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Departments of *Anesthesiology,
Orthopedic Surgery and
Biomechanics Unit, University Hospital of Zurich/Balgrist, Zurich, Switzerland
Address correspondence and reprint requests to Alain Borgeat, MD, Chief of Staff Anesthesiology, University Clinic of Zurich/Balgrist, Forchstrasse 340, CH-8008 Zurich, Switzerland. Address e-mail to aborgeat{at}balgrist.unizh.ch
| Abstract |
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Implications: We compared the patient-controlled interscalene analgesia technique with ropivacaine 0.2% and bupivacaine 0.15% after major open shoulder surgery. For similar pain control ropivacaine is associated with better preservation of strength in the hand and less paresthesia in the fingers.
| Introduction |
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| Patients and Methods |
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Patients were assigned a number between 1 to 60 by choosing a sealed envelope containing a number. Each patient number was passed on to a pharmacist who prepared the anesthetic set (bolus and maintenance package) of either ropivacaine or bupivacaine according to a computerized randomization list. All patients had an ISB performed before the induction of general anesthesia. The brachial plexus was identified using a nerve stimulator ( Stimuplex, DIGTM ; B. Braun Melsungen AG, Melsungen, Germany) connected to the proximal end of the metal inner needle of a plastic cannula ( ContiplexTM ; B. Braun Melsungen AG). Placement of the needle was considered successful when a contraction of the triceps muscle was obtained with a current output of <0.5 mA. A catheter (Contiplex; 23F with stylet) was introduced distally between the anterior and middle scalene muscles for up to 34 cm. The catheter was subcutaneously tunneled over 34 cm through an 18-gauge IV cannula and fixed to the skin with adhesive tape. ISB was performed with either 40 mL ropivacaine 0.6% or 40 mL bupivacaine 0.5%. All patients received the drug by means of the catheter. Interscalene block was confirmed by a sensory (inability to recognize cold temperature) and motor block (inability to extend the arm, pins and needles type of paresthesia in the tip of the first and third finger) involving the radial and median nerve within 20 min after the administration of local anesthetic.
The general anesthetic technique used (when necessarypatients wish) was standard for all patients. They were premedicated with 0.1 mg/kg midazolam given orally 1 h before the ISB. After the block was complete, the induction was performed with 1.52 mg/kg of propofol and anesthesia was maintained with 810 mg · kg-1 · h-1 of propofol. Tracheal intubation was facilitated using 0.8 mg/kg rocuronium and 11.5 µg/kg of fentanyl was given within 3 min before tracheal intubation. Those who had no general anesthesia were allowed to receive propofol for sedation, if needed. All patients received an infusion of local anesthetics through the interscalene catheter in the recovery room, starting 6 h after the initial ISB. Both groups had a continuous infusion (0.2% ropivacaine vs 0.15% bupivacaine) at a rate of 5 mL/h plus a bolus dose of 4 mL with a lockout time of 20 min. The infusion was stopped 48 h after the ISB and the study was completed 54 h after the ISB. All patients received 2 g of propacetamol (the predrug of acetaminophen) IV four times a day on a regular basis. Rescue treatment consisted of morphine 0.1 mg/kg subcutaneously given on patient request.
Hand strength was measured by means of a soft rubber bulb, the "bulb grip device" ( Fig. 1), connected to an electronic pressure transducer (Abbott Critical Care Systems, Abbott, Ireland). The bulb could be held in the hand and squeezed comfortably and was filled with water to offer resistance. The rubber bulb is oval-shaped, as in common use for inflating the pneumatic cuff of a conventional sphygmomanometer. The inlet to the bulb was sealed with a plug after being filled with water. The hydrostatic pressure, which increased on being squeezed, was measured with the pressure transducer connected to the bulb outlet. The transducer delivered an analog electrical signal, directly proportional to the pressure. The pressure transducer was of the electrical resistance type, using a Wheatstone bridge circuit. The bridge was supplied from a 5V stabilized DC source and its output amplified by means of a DC amplifier (x100) before being led to a chart recorder ( Watanabe® Type WX 441 ; Watanabe Instrument Corp., Tokyo, Japan) adjusted to 0.1 V/cm sensitivity and set to a sweep rate of 1 cm/s (Fig. 1). The system was calibrated by use of a Bourdon-type manometer with a range of 0 to 760 mm Hg that allowed pressure to be read from a scale, graduated in steps of 10 mm Hg, simultaneously. For the purpose of calibration, an external source of pressure that could be adjusted by means of a valve was also connected to the system. The pressure was adjusted in steps of approximately 50 mm Hg from 0 to 650 mm Hg, and the output voltage was recorded. The output signal exhibited a linear relationship of 729 mm Hg/V, or 72.9 mm Hg/cm on the chart recorder. Analysis of four calibration sequences showed a linear regression coefficient of 0.996 with a standard deviation of ±17.7 mm Hg. The sensitivity of the device was mainly determined by the chart recorder, which could easily be read to within ±1mm (corresponding to ±7mm Hg). Strength of the hand was assessed by one of the surgeons involved in the study. Because the grip strength is dependent on the position of the limbs, the control measurement (preoperative value) was taken in the postoperative position. All patients were able to use the device. The measurement was repeated 24 h, 48 h, and 54 h after the initial ISB. Each measurement was repeated three times and the one with the highest reading chosen.
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The primary end point of the study was the strength of the hand on the operated side. From our previous experience (4,5), we estimated the variation of strength between the patients in this clinical setting to be 25%. Using type I (
) and type II (ß) errors of 0.05 and 0.2 respectively, and considering a 20% difference in the strength between the groups as a minimal relevant difference, we calculated that a sample of 25 patients per group would be necessary. To increase the power, we added five more patients per group. Data are reported as mean ± SD unless otherwise stated. Demographic data, time of first bolus, and patient satisfaction and number of auto-administered boli were assessed using the Mann-Whitney U-test. The strength in the hand and the pain scores were compared between the two groups by using the Mann-Whitney U-test with Bonferronis correction for multiple comparisons. Side effects were analyzed using Fishers exact test. The incidence of paresthesia was evaluated by Fishers exact test with Bonferronis correction for multiple comparisons. For all determinations, a P value < 0.05 was considered significant.
| Results |
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| Discussion |
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The evaluation of motor block associated with the application of local anesthetics still has no "gold standard" for reference. The use of the Bromage scale (6) or its modified version have been extensively applied during labor (7,8), after abdominal surgery (9,10) and in orthopedics (11,12). However, such scales may not permit detection of subtle variations in motor block and cannot be applied in patients after major open shoulder surgery. The assessment of hand strength is a good means to evaluate and compare the effects of a brachial plexus block (interscalene, infraclavicular, or axillary) on motor function. Available devices such as the Jamar dynamometer (13) proved, in our experience, to be difficult for patients to handle in this clinical setting because of its weight and decreased compliance. To overcome the conditions imposed by this type of surgery on the positioning of the arm, we built the "bulb grip device," which is only 90 g when filled with water, easy to grip and handle, reliable, and permits the detection of small strength differences.
We chose to administer a bolus of 40 mL of either ropivacaine 0.6% or bupivacaine 0.5%, in contrast to 30 mL in our previous studies (4,5), as some patients wished to have the surgical procedure without general anesthesia. The analgesic regimen of 0.2% ropivacaine and 0.15% bupivacaine was chosen because our previous studies (4,5) have shown these two concentrations to be associated with good and comparable pain control after this type of surgery. Our previous experience has shown that smaller concentration than the above of either ropivacaine or bupivacaine do not produce adequate postoperative pain control in this context. This concentration difference of 25% (0.2% ropivacaine versus 0.15% bupivacaine) that leads to similar pain control complies with the shown difference in pharmacodynamics (potency) as shown by Capogna et al. (14) for these two drugs, although a direct comparison may not be applicable because in the latter study epidurals were studied. This point is crucial, as similar pain control is the required condition to be unbiased with respect to the effects of the therapy on the motor function of the hand. We do not believe that some patients having general anesthesia might have influenced the results because these patients received only 100 µg fentanyl for endotracheal intubation and a small-dose continuous infusion of propofol for maintenance of anesthesia, the effects of which rapidly disappear.
The pain was assessed at rest and in motion during the effort to squeeze the rubber bulb. Interestingly, the maximum effort needed to squeeze the bulb does not increase pain intensity. This observation points out that with use of the interscalene catheter technique with local anesthetic, good control of pain at rest will allow easy passive/active early rehabilitation (observation confirmed by our physiotherapist team), which is not the case with the IV opioid technique. Indeed, all patients who have a very small level of pain with the continuous ISB are able to perform movement of the shoulder without any significant increase in level of pain.
During the course of the trial, we did not feel it necessary to assess the sensory and motor block other than with VAS and hand strength because the randomized, double-blinded design of the study, similar ISB procedure, placement of the catheter in the proximity of the radial nerve in all patients, and absence of block failure or catheter dislocation should prevent any significant difference in block extension in either group.
Chance randomization led to an increased number of women in the Bupivacaine group. To avoid a bias resulting from sex difference, we performed a second statistical analysis by excluding the women and found the results to be similar. This led us to conclude that sex did not have a statistical influence on the results in the present study.
Most studies that compared ropivacaine and bupivacaine in the postoperative period after various surgical procedures found either a similar motor block or a decrease in motor block in patients receiving ropivacaine (15,16). However, the clear-cut differences in motor block between ropivacaine and bupivacaine may have been obscured by a different sensory block shown by the need of more analgesics in one group or the other (14) or by the method of assessment, the Bromage scale or its modified version. Indeed, Zaric et al. (17) demonstrated that the Bromage scale does not correlate with more sophisticated means of measurement, such as electromyographic and mechanical assessment of isometric muscle force. In this investigation, we measured the dose response of sensory and motor block during continuous epidural infusion of 0.1, 0.2, or 0.3% ropivacaine in volunteers, as compared with bupivacaine 0.25% and isotonic saline. The different solutions were infused for 21 h. They found that motor block was minimal with 0.1% ropivacaine, moderate with 0.2 and 0.3% ropivacaine, and most intense with 0.25% bupivacaine. The regression phase was significantly shorter with all three concentrations of ropivacaine than with bupivacaine. However, the sensory block, as evaluated by the thermo test, did not show any difference between the groups. Despite the different concentration of local anesthetics used in our protocol, some of the observations made by Zaric et al. (17) correlated with our results. Indeed, for an equivalent analgesia, the motor block assessed by hand strength was more pronounced in the Bupivacaine group, as well as the prolongation of regression phase, shown not only by hand strength, but also by the persistence of paresthesia. The transient paresthesia may not be considered in the present context as a complication, but most likely as a prolonged more intense motor blockade in the Bupivacaine group.
The total number of auto-administered boli was similar in the two groups, confirming the results found in our previous investigations (4,5) using a similar protocol for bupivacaine 0.15% and ropivacaine 0.2% respectively. Interestingly, the patients needed only 20% of the total number of boli permitted (18.3% and 19.3% for the Bupivacaine and Ropivacaine groups, respectively). We may therefore wonder if it would be possible to use a smaller local anesthetic concentration; however, in a previous pilot study (unpublished results), we found that bupivacaine 0.1% and ropivacaine 0.15% provided insufficient analgesia in more than 50% of patients after major open shoulder surgery.
We believe a better sensorimotor dissociation of ropivacaine is probably the most likely way to explain our results, although a different extension of the block could have occurred, but seems unlikely, as the technique was exactly the same in both groups. Rosenberg and Heinonen (2), using isolated sheathed vagus and phrenic nerves of rats, showed that ropivacaine at a small concentration produced a rapid and profound block of A
and C fibers and was more potent than similarly small concentration of bupivacaine in blocking the same fibers. At larger concentrations, ropivacaine and bupivacaine had similar blocking activity. An animal experimental study conducted by Wildsmith et al. (3) demonstrated that ropivacaine blocked C fibers faster than A fibers and was a potent producer of frequency-dependent block. It is known that low pKa and high lipid solubility are associated with preferential blockade of A fibers; high pKa and low lipid solubility are associated with preferential blockade of C fibers (1). The lower lipid solubility of ropivacaine compared with bupivacaine is presumed to retard penetration of myelin sheaths. The combination of higher degree of sensorimotor dissociation with ropivacaine at small concentrations and the property of being a potent producer of frequency-dependent block may in part explain some of its advantages for postoperative analgesia.
The incidence of nausea and vomiting was infrequent and similar in both groups and within the range of our previous results (4,5). The degree of patient satisfaction was high in the two groups and comparable to the one found in the previous trials (4,5).
In conclusion, this study demonstrates that the administration of ropivacaine 0.2% and bupivacaine 0.15% through an interscalene catheter after major open shoulder surgery provides good and comparable control of postoperative pain with few side effects and a high degree of patient satisfaction. However, the application of ropivacaine 0.2% by the PCIA technique is associated with a decreased incidence of paresthesia in the fingers and offers a better preservation of motor function, assessed by hand strength. If these factors facilitate early rehabilitation and improve patient well being, this warrants further investigations.
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