Krankenhäuser des Landkreises Aichach, Friedberg, Germany

In this study, the pharmacokinetics, tolerability and efficacy of 40 ml of ropivacaine 7.5 mg/ml (300 mg) for axillary brachial plexus block were investigated. With institutional review board approval, 10 patients presenting for surgery of the upper limb were enrolled in this open study. The axillary plexus was identified with a nerve stimulator and the study drug was injected into the neurovascular sheath. Fifteen venous blood samples were obtained from each patient for pharmacokinetic measurements over a 24-h period. All blocks were sufficient for surgery after 45 min without any need for supplemental analgesia or general anesthesia. The mean (SD) peak plasma concentration was 2.3 (0.8) mg/l at median tmax 54 min (range 16-92 min). The mean (SD) maximum free plasma concentration was calculated to be 0.12 (0.06) mg/l (range 0.07-0.29 mg/l). The t 1/2 was about 6 h. There were no clinical signs or symptoms of central nervous system and/or cardiac toxicity in any patient. Ropivacaine 7.5 mg/ml, used in a dose of 300 mg, was effective and well tolerated for axillary brachial plexus block.

PMID: 11996328 - www.pubmed.com

PURPOSE: To compare analgesia after intraoperative single shot "3-in-1" femoral nerve block (FNB) in combination with general anesthesia using ropivacaine 0.25%, ropivacaine 0.5% with bupivacaine 0.25% for total knee replacement (TKR).

METHODS: We performed a randomized, double-blind study in 48 patients for elective TKR under general anesthesia. Patients were randomized to one of four groups (C: sham block, R1: "3-in-1" FNB using 30 mL of ropivacaine 0.25%, R2: "3-in-1" FNB using 30 mL of ropivacaine 0.5%, B: "3-in-1" FNB using 30 mL of bupivacaine 0.25%). Verbal pain score (VPS) both at rest and movement were assessed for 48 hr after TKR (0=none; 1=mild; 2=moderate; 3=severe). Total morphine consumption and its associated side effects, duration of hospitalization after operation were also compared.

RESULTS: There were no differences in patients' physical characteristics, intraoperative morphine usage, operation time, tourniquet time or length of hospitalization between the four groups. When compared with group C, the VPS was significantly lower in groups R1, R2 and B at one, four, eight, 24 and 48 hr after TKR (P <0.05). The morphine requirement of groups R1, R2 and B were also significantly lower when comparing with group C up to 48 hr postoperatively (P <0.05). There were no significant differences in VPS and postoperative morphine requirement at any time between groups R1, R2 and B.

CONCLUSION: "3-in-1" FNB with ropivacaine provided analgesia that was clinically comparable to that of bupivacaine up to 48 hr after TKR. Increasing the concentration of ropivacaine from 0.25% to 0.5% failed to improve the postoperative analgesia of "3-in-1" FNB.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 11744586 - www.pubmed.com

We report a patient to whom ropivacaine 1.1 mg kg(-1) was administered for brachial plexus blockade and who developed grand mal convulsions because of inadvertent i.v. injection. No symptoms of cardiovascular toxicity occurred. Venous blood samples were taken 15, 45, 75 and 155 min after the injection. The measured total plasma concentrations of ropivacaine were 3.3, 1.6, 1.2 and 1.0 mg litre(-1) respectively. Initial plasma concentration after the end of the injection period was estimated at 5.75 mg litre(-1) using a two-compartment pharmacokinetic model.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 11878534 - www.pubmed.com

OBJECTIVES: To evaluate the distribution of sensory blockade, the onset time and the duration of the axillary plexus block obtained after the administration of 40 mL of 1.5% lignocaine with adrenaline or 40 mL of plain 1.5% mepivacaine.

STUDY DESIGN: Prospective, randomised, comparative, double blind study.

PATIENTS AND METHODS: One hundred and fifty five patients undergoing hand surgery were randomised into two groups: in group L, 73 patients were given 1.5% lignocaine with 1/200,000 adrenaline and in group M, 82 patients received 1.5% mepivacaine. The entire volume was injected on the first evoked motor activity obtained for a current less than 0.5 mA. Sensory and motor block of each of the four major nerves of the hand and forearm were assessed using light touch and motor strength respectively. The block was considered complete when all nerves were anaesthetised (median, radial, musculocutaneous and ulnar).

RESULTS: The percentage of complete sensitive blockade was 22% in group L and 24% in group M. Complete motor blockade was respectively 27% in group L and 40% in group M. The median time required to obtain a complete sensory blockade was 18 min for both group. The median time required to obtain a complete motor blockade was 17 min in-group L and 16 min in-group M. The duration of the sensory blockade was not different for both groups (i.e., 255 76 min versus 231 70 min in group L and M respectively. The duration of the motor blockade was longer in group L compared to group M (199 64 min versus 231 74 min respectively, p < 0.05).

CONCLUSION: Following axillary plexus block, 1.5% mepivacaine improves neither the extension nor the duration of sensory blockade achieved by 1.5% lignocaine with adrenaline.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 11695288 - www.pubmed.com

Ropivacaine, the S-(-)-enantiomer of N-(2,6-dimethylphenyl)-1-propyl-2-piperidinecarboxamide is a new long-acting local anesthetic. This review demonstrates that it is effective in brachial plexus anesthesia. It is at least as efficient as bupivacaine in terms of quality, duration of analgesia, anesthesia, and motor block. It could have some advantages over bupivacaine in terms of onset time of sensory and motor block, but this remains controversial. In single-shot brachial plexus block, it is equipotent to bupivacaine and has a similar pharmacokinetic profile. Its minimal effective concentration is 0.5%, and the benefit of increasing its concentration to 0.75 or 1% remains debatable. Its use during continuous brachial plexus block has been much less studied, and conflicting results involving efficacy during continuous interscalene block and inefficacy during continuous axillary block have been obtained. Further investigations are required to assess its efficacy during such block. Because of lower CNS and cardiac toxicity, ropivacaine is safer than bupivacaine. It would be thus the preferred local anesthetic for brachial plexus blockade when long-lasting anesthesia and analgesia is required.

PMID: 11895140 - www.pubmed.com

BACKGROUND: The aim of this prospective, randomized, double-blind study was to evaluate the effects of adding 1 microg/kg clonidine to 20 ml of ropivacaine 0.75% for axillary brachial plexus anesthesia.

METHODS: With Ethical Committee approval and written consent, 30 ASA physical status I-II in-patients, undergoing upper extremity orthopedic procedures were randomly allocated to receive axillary brachial plexus block with 20 ml of 0.75% ropivacaine alone (group ropivacaine, n = 15) or 0.75% ropivacaine + 1 microg/kg clonidine (group ropivacaine-clonidine, n = 15). Nerve blocks were placed using a nerve stimulator with the multiple injection technique (stimulation frequency was 2 Hz; stimulation intensity was decreased to < or = 0.5 mA after each muscular twitch; the anesthetic volume was equally divided among arm flexion, arm extension, wrist flexion, and thumb adduction). A blinded observer recorded the time required to achieve surgical block [loss of pinprick sensation in the innervation areas of the hand (C6-C8) with concomitant inability to move the wrist and hand] and first analgesic request.

RESULTS: No differences in demography, degree of sedation, peripheral oxygen saturation, and hemodynamic variables were observed between the two groups. Readiness for surgery required 15 min (5-36 min) with 0.75% ropivacaine and 20 min (5-30 min) with the ropivacaine-clonidine mixture. The degree of pain measured at first analgesic request, and consumption of postoperative analgesics were similar in the two groups; while first postoperative analgesic request occurred after 13.8 h (25th-75th percentiles: 9.1-13 h) in the ropivacaine group and 15.2 h (25th-75th percentiles: 10.7-16 h) in the ropivacaine-clonidine group (p = 0.04).

CONCLUSIONS: Adding 1 microg/kg clonidine to 20 ml of ropivacaine 0.75% for axillary brachial plexus anesthesia provided a 3 h delay in first analgesic request postoperatively, without clinically relevant effects on the degree of sedation and cardiovascular homeostasis.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 11382830 - www.pubmed.com

PURPOSE: To evaluate the effect of adding clonidine to ropivacaine, for axillary brachial plexus blockade, on the onset and duration of sensory and motor block and duration of analgesia.

METHODS: In a prospective randomised double blind placebo controlled study axillary brachial plexus blockade was performed in 50 patients using 40 ml ropivacaine 0.75%. Group (A) had 150 microg clonidine and Group (B) 1 ml normal saline added to the local anesthetic. Sensory function was tested using pinprick (sharp sensation, blunt sensation or no sensation) and temperature with an ice cube compared with the opposite arm, (cold/not cold). Motor function was assessed using a modified Bromage scale. Postoperative analgesia was standardised. Onset and duration of sensory and motor blockade, duration of analgesia, postoperative pain score, and analgesic requirement were compared.

RESULTS: The clonidine patients showed an increase in duration of sensory loss from 489 min to 628 min with a mean difference of 138 min (95% confidence interval of 90 to 187 min), motor blockade from 552 min to 721 min with a mean difference of 170 min (95% confidence interval of 117 to 222 min), and analgesia from 587 min to 828 min with mean difference of 241 min (95% confidence interval of 188 to 294 min). There was no difference in onset time. No side effects were noted.

CONCLUSION: The addition of 150 microg of clonidine to ropivacaine, for brachial plexus blockade, prolongs motor and sensory block and analgesia, without an increased incidence of side effects.

Publication Types:
Clinical Trial
Randomized Controlled Trial

PMID: 11032270 - www.pubmed.com

INTRODUCTION: The new long-acting local anesthetic ropivacaine is a chemical congener of bupivacaine and mepivacaine. The admixture of clonidine to local anesthetics in peripheral nerve block has been reported to result in a prolonged block. The aim of the present study was to evaluate the effects of clonidine added to ropivacaine on onset, duration and quality of brachial plexus block.

METHODS: Patients were randomly allocated into two groups. In group I brachial plexus was performed using 40 ml of ropivacaine 0.75% plus 1 ml of NaCL 0.9%, and in group II brachial plexus was performed using 40 ml of ropivacaine 0.75% plus 1 ml (0.150 mg) of clonidine. Onset of sensory and motor block of radial, ulnar, median and musculocutaneous nerve were recorded. Motor block was evaluated by quantification of muscle force, according to a rating scale from 6 (normal contraction force) to 0 (complete paralysis). Sensory block was evaluated by testing response to a pinprick in the associated innervation areas. Finally, the duration of the sensory block was registered. Data were expressed in meanSD. For statistical analysis a Student t-test was used. A P-value of < or = 0.05 was considered as statistically significant.

RESULTS: The duration of blockade was without significant difference between the groups. Group I: 71890 min; Group II: 727117 min. There was no intergroup difference in sensory and motor onset or in quality of blockade.

CONCLUSION: The addition of clonidine to ropivacaine 0.75% does not lead to any advantage of block of the brachial plexus when compared with pure ropivacaine 0.75%.

Publication Types:
Clinical Trial
Randomized Controlled Trial

Comment in:
Acta Anaesthesiol Scand. 2000 Oct;44(9):1163-4

PMID: 10710260 - www.pubmed.com

BACKGROUND AND OBJECTIVES: Although ropivacaine has been extensively studied for epidural anesthesia, very few reports exist on brachial plexus block. We therefore decided to investigate the clinical features of axillary brachial plexus anesthesia with two different concentrations of ropivacaine (0.5% and 0.75%) and to compare the results with those obtained with 0.5% bupivacaine.

METHODS: Three groups of patients were randomized and prospectively studied. They received, in a double-blind fashion, 32 mL of the local anesthetic solution into the midaxilla, by a nerve-stimulator technique. Onset time in each of the stimulated nerves was recorded both for the sensory and motor block. Peak time (ready to surgery), rate of supplemental blocks, need for intraoperative opioids, duration of sensory and motor block, postoperative analgesic requirements, and patient satisfaction were also recorded.

RESULTS: The rate of complete sensory and motor block observed with both ropivacaine groups was higher at 10, 15, and 20 minutes postinjection (P < .001). The mean peak time was shorter with ropivacaine than with bupivacaine (R50 = 16.37 minutes, R75 = 14.7 minutes, B = 22.3 minutes, P < .05). The quality of the anesthesia was higher with ropivacaine, as measured by the intraoperative needs for opioids and the overall patient's satisfaction (P < .05). No significant differences were noted with all the other studied parameters.

CONCLUSION: Ropivacaine showed advantages over bupivacaine for axillary brachial plexus block. Because no statistical differences were found between the two ropivacaine groups, we therefore conclude that 0.75% does not add benefit and that 0.5% ropivacaine should be used to perform axillary brachial plexus blocks.

Publication Types:
Clinical trial
Randomized controlled trial

PMID: 10588554 - www.pubmed.com

BACKGROUND: Bupivacaine provides reliable, long-lasting anesthesia and analgesia when given via the caudal route. Ropivacaine is a newer, long-acting local anesthetic that (at a concentration providing similar pain relief) has less motor nerve blockade and may have less cardiotoxicity than bupivacaine.

METHODS: In a double-blind trial, 81 healthy children, undergoing ambulatory surgical procedures, were randomly allocated to receive caudal analgesia with either bupivacaine or ropivacaine, 0.25%, 1 mVkg. All blocks were placed by an attending anesthesiologist or an anesthesia fellow after induction of general anesthesia.

RESULTS: Data were available for 75 children. There were no significant differences between the two groups in baseline characteristics or in anesthesia, surgery, recovery room, or day surgery unit durations. The quality and duration of postoperative pain relief did not differ. Motor and sensory effects were similar. Time to first micturition did not differ.

CONCLUSION: Ropivacaine (0.25%, 1 ml/kg) provided adequate postoperative analgesia with no difference from bupivacaine (0.25%, 1 ml/kg) in quality and duration of pain relief, motor and sensory effects, or time to first micturition in our study children.

Publication Types:
Clinical trial
Randomized controlled trial

PMID: 10551577, UI: 20017739 - www.pubmed.com

BACKGROUND: The authors compared the effects of patient-controlled interscalene analgesia (PCIA) with ropivacaine 0.2% and patient-controlled intravenous analgesia (PCIVA) with opioids on hemidiaphragmatic excursion and respiratory function after major shoulder surgery.

METHODS: Thirty-five patients scheduled for elective major shoulder surgery were prospectively randomized to receive either PCIA or PCIVA. All patients received an interscalene block before surgery. In the PCIA group, a catheter was introduced between the anterior and middle scalene muscles. Six hours after the initial block, patients received for 48 h either a continuous infusion of 0.2% ropivacaine through the interscalene catheter at a rate of 5 ml/h plus a bolus dose of 3 or 4 ml with a lockout time of 20 min (PCIA group) or a continuous intravenous infusion of nicomorphine at a rate or 0.5 mg/h plus a bolus dose of 2 or 3 mg with a lockout time of 20 min (PCIVA group). Hemidiaphragmatic excursion and respiratory function were assessed with the patient in a 45 degrees semirecumbent position the day before the operation and 20 min (in the operating room), 24 h, and 48 h after the initial block by means of ultrasonography and spirometry, respectively. Pain relief was regularly assessed, side effects were noted, and patient satisfaction was rated 6 h after the end of the study.

RESULTS: Hemidiaphragmatic excursion was similar in the two groups 20 min after interscalene block. Hemidiaphragmatic excursion was increased in the PCIA group on the nonoperated side 24 and 48 h after the interscalene block (P < 0.05). Pulmonary function was similar in the two groups at each time. Pain was better controlled in the PCIA group at 12 and 24 h (P < 0.05). The incidence of nausea and vomiting were 5.5% versus 60% for the PCIA and PCIVA groups, respectively (P < 0.05). Patient satisfaction was greater in the PCIA group (P < 0.05).

CONCLUSIONS: The use of PCIA or PCIVA techniques to provide analgesia after major shoulder surgery is associated with similar effects on respiratory function. In the PCIA group, hemidiaphragmatic excursion showed a significantly greater amplitude 24 and 48 h after the initial block on the nonoperated side. The PCIA technique provided better pain control, a lower incidence of side effects, and a higher degree of patient satisfaction.

PMID: 10638905, UI: 20102443 - www.pubmed.com

The purpose of this prospective, randomized, double-blinded study was to evaluate the sensory onset time and the quality of sensory block of ropivacaine, a new long-acting local anesthetic, compared with bupivacaine, for 3-in-1 blocks. Fifty ASA physical status I-III patients undergoing hip surgery after trauma were randomly assigned to two study groups of 25 patients each. The two study groups received a 3-in-1 block with either 20 mL of ropivacaine 0.5% or 20 mL of bupivacaine 0.5%. Blocks in both groups were performed using a nerve stimulator. The sensory onset time and the quality of sensory block was assessed by pinprick test in the central sensory region of each of the three nerves and compared with the same stimulation in the contralateral leg. We used a scale from 100% (normal sensation) to 0% (no sensory sensation). We did not find significant differences in sensory onset times between the ropivacaine group and the bupivacaine group (30+/-11 vs 32+/-10 min). The quality of sensory blocks was also comparable between the study groups (19%+/-20% vs 21%+/-15%). We conclude that the sensory onset time and quality of sensory block during 3-in-1 blocks performed with ropivacaine are comparable to those with bupivacaine. Ropivacaine is described as being less potent than bupivacaine, making this local anesthetic promising for 3-in-1 blocks because of its reportedly lower incidence of cardiovascular and central nervous system complications. IMPLICATIONS: Ropivacaine 0.5% has a sensory onset time and quality of sensory block during 3-in-1 blocks similar to that of bupivacaine 0.5%. Ropivacaine is described as being less potent than bupivacaine, making it a promising local anesthetic for 3-in-1 blocks because of its reportedly lower cardiovascular and central nervous system toxicity.

Publication Types:
Clinical trial
Randomized controlled trial

PMID: 10624992, UI: 20088330 - www.pubmed.com

The onset time and duration of action of ropivacaine during an interscalene block are not known. The potentially improved safety profile of ropivacaine may allow the use of higher concentrations to try and speed onset time. We compared bupivacaine and ropivacaine to determine the optimal long-acting local anesthetic and concentration for interscalene brachial plexus block. Seventy-five adult patients scheduled for outpatient shoulder surgery under interscalene block were entered into this double-blind, randomized study. Patients were assigned (n = 25 per group) to receive an interscalene block using 30 mL of 0.5% bupivacaine, 0.5% ropivacaine, or 0.75% ropivacaine. All solutions contained fresh epinephrine in a 1:400,000 concentration. At 1-min intervals after local anesthetic injection, patients were assessed to determine loss of shoulder abduction and loss of pinprick in the C5-6 dermatomes. Before discharge, patients were asked to document the time of first oral narcotic use, when incisional discomfort began, and when full sensation returned to the shoulder. The mean onset time of both motor and sensory blockade was <6 min in all groups. Duration of sensory blockade was similar in all groups as defined by the three recovery measures. We conclude that there is no clinically important difference in times to onset and recovery of interscalene block for bupivacaine 0.5%, ropivacaine 0.5%, and ropivacaine 0.75% when injected in equal volumes.

IMPLICATIONS: In this study, we demonstrated a similar efficacy between equal concentrations of ropivacaine and bupivacaine. In addition, increasing the concentration of ropivacaine from 0.5% to 0.75% fails to improve the onset or duration of interscalene brachial plexus block.

Publication Types:
Clinical trial
Randomized controlled trial

PMID: 9842819, UI: 99056953 - www.pubmed.com

OBJECTIVE: To compare analgesia produced after surgery for severe hand trauma, by a continuous axillary block obtained either with a continuous injection (CA) or controlled by the patient (PCA). STUDY DESIGN: Prospective, randomized study.

PATIENTS: Forty-two ASA physical class 1 and 2 patients were enrolled over a twelve-month period and randomly allocated either into the CA or the PCA group.

METHODS: After recovery from the surgical block, the axillary plexus was located using a nerve stimulator and a 20 G catheter (Contiplex B Braun) inserted over 5 centimeters into the axillary sheath. In the CA group (n = 21) patients received 0.1 mL.kg-1.h-1 of 0.25% bupivacaine and in the PCA group (n = 21) patients received 0.1 mL.kg-1 boluses of 0.25% bupivacaine with a one hour lock-out period. Data collected were pain intensity rated according to he visual analog scale (VAS), the total volume of bupivacaine injected, the quantity of nalbuphine administered as 10 mg boluses when VAS was = 5, and the patient's satisfaction after removal of the catheter. Statistical analysis used Student t test, ANOVA and chi 2 test.

RESULTS: The mean duration of catheter use was 5 +/- 3 days. During this period the amount of bupivacaine was significantly reduced in the PCA group when compared to the CA group (P < 0.001). Similarly, the PCA group required significantly less nalbuphine. Finally, in this group, the satisfaction index was higher than in the CA group (95 versus 52% respectively, P < 0.01).

CONCLUSION: Continuous axillary plexus blockade provides safe and effective postoperative analgesia. With the PCA technique results a lower quantity of bupivacaine is required and patient's satisfaction better.

Publication Types:
Clinical trial
Randomized controlled trial

PMID: 9835978, UI: 99052698 - www.pubmed.com

A double-blind, controlled trial was conducted to determine whether warming local anaesthetic reduces the onset time of axillary brachial plexus block. Forty patients were randomised into two groups. The control group received local anaesthetic solution at room temperature (22 +/- 1 degrees C), while the experimental group received the solution at body temperature (37 +/- 1 degrees C). A solution of 40 ml of lignocaine 1.5% with adrenaline 1:200,000 was used for all patients. Warming the local anaesthetic was not demonstrated to reduce the latency of onset of blockade.

Publication Types:
Clinical trial
Randomized controlled trial

PMID: 8122736, UI: 94168265 - www.pubmed.com

Three patients, presenting with various traumatic, vasospastic and chronic neuromuscular disorders of the upper body, received continuous axillary block ranging from 4 to 16 days. Intermittent injections of 0.25% bupivacaine were used to provide analgesia, sympathetic blockade and muscle relaxation. No systemic or neurological side-effects were recorded. Nerve function recovered promptly after stopping the injections. It is concluded that continuous brachial plexus blockade is a clinically safe and effective technique for the relief of acute traumatic pain and vasospastic disorders of the upper limb. The technique, its merits and possible complications are discussed.

PMID: 2239126, UI: 91050344 - www.pubmed.com

We estimated in this study the efficacy of axillary plexus blockade with 60 ml prilocaine 0.5% (300 mg). Following electrostimulation of the median, radial or ulnar nerve (depending on the area of the hand to be operated on), we injected prilocaine in two groups of patients (large volume group, 60 ml prilocaine 0.5% in 20 s; n = 114 patients; normal volume group, 40 ml prilocaine 1% in 20 s; n = 30 patients). Anesthesia of the median and ulnar nerves was virtually complete in all patients, but anesthesia of the radial and musculocutaneous nerves was complete in only 67% (radial) and 75% (musculocutaneous) in the group with normal injection volume. The injection of a larger volume but a lower concentration of prilocaine (300 mg) achieved better anesthesia of the radial (81%) and musculocutaneous (92%) nerves by 30-60 min after the injection. This difference was significant (p less than 0.05). The measurement of higher subfascial pressure in the axillary plexus following the larger volume of 60 ml than after 40 ml could explain the improved efficacy in overcoming anatomical hindrances in the plexus space. Estimation of the prilocaine concentration in the central venous blood 120 min after injection did not reveal different plasma concentrations in the two groups. The plasma concentrations were far below toxic levels. Only the time of plasma peak was earlier in the group with the larger volume, which was attributed to the larger area of diffusion of the vascular system in the plexus space.

PMID: 2389068, UI: 90356847 - www.pubmed.com

Department of Anaesthetics, Addenbrooke's Hospital, Cambridge. A double-blind study was set up to investigate the effect of warming local anaesthetic solutions on the latency of onset of subclavian perivascular brachial plexus blocks. Twenty-four adult patients were randomly allocated into two equal groups. In group A the local anaesthetic was injected at room temperature, while in group B the local anaesthetic solution was prewarmed to 37 degrees C in a thermostatically controlled heating block. All blocks were performed using 0.5 ml/kg of a solution prepared by mixing equal volumes of 0.5% bupivacaine with adrenaline 1:200,000, and 1% prilocaine. The speed of onset of sensory blockade was significantly increased when the temperature of the local anaesthetic solution was increased to 37 degrees C. There were no adverse side effects in either group.

Publication Types:
Clinical trial
Randomized controlled trial

PMID: 2337214, UI: 90247618 - www.pubmed.com