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© 2001 International Anesthesia Research Society
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Abstract |
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To assess the effect of local anesthetic wound instillation on visceral and somatic pain, we studied 36 patients undergoing total abdominal hysterectomy and bilateral salpingo-oophorectomy. A standard general anesthetic was administered. On completion of the operation, a multiorifice 20-gauge epidural catheter was placed above the superficial abdominal fascia such that the tip was at the midpoint of the surgical wound. After surgery, either bupivacaine 0.25% (Bupivacaine group) or sterile water (Control group) was administered via a patient-controlled analgesia device programmed to deliver 9.0 mL with a 60-min lockout interval. During the first 6 h after surgery, rescue IV morphine (2 mg) was administered every 10 min until a visual analog scale score of <30 mm was achieved. Thereafter, on patient request, rescue meperidine 1 mg/kg IM was administered. When compared with the Control group, significantly (P < 0.001) less rescue analgesia was administered to patients in the Bupivacaine group. Rescue morphine administered during the first 6 h after surgery was 6 ± 4 mg versus 12 ± 6 mg (P < 0.001) for the Bupivacaine and Control groups, respectively. Rescue meperidine administered was 29 ± 37 mg versus 95 ± 36 mg (P < 0.001) for the Bupivacaine and Control groups, respectively. Nausea and antiemetic drug administration was significantly (P = 0.003) less in the Bupivacaine group. Pain scores were similar between the groups. Patient satisfaction was significantly (P = 0.04) more in the Bupivacaine group. We conclude that bupivacaine wound instillation decreases opioid requirements and nausea in the first 24 h after total abdominal hysterectomy with bilateral salpingo-oophorectomy.
IMPLICATIONS: Bupivacaine instillation via an electronic patient-controlled analgesia device provides effective analgesia after total abdominal hysterectomy with bilateral salpingo-oophorectomy.
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Introduction |
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As a result of their analgesic properties and lack of opioid-induced adverse effects, local anesthetic drugs have become increasingly popular for treating surgical pain (1–4). In addition to providing good postoperative analgesia, local anesthetic infiltration is simple, safe, and inexpensive. However, because of the short duration of action associated with local anesthetic drugs, the need for repeated drug administration constitutes a major limitation to their widespread use. To overcome this limitation, repeated local anesthetic wound instillation has been attempted.
By using an elastometric (balloon) pump to facilitate patient-controlled local anesthetic wound instillation in the home setting, Rawal et al. (5) demonstrated the analgesic efficacy of this technique after a variety of day-case procedures. Similarly, ropivacaine instillation after cesarean delivery was associated with opioid sparing and improved patient comfort (6). However, the analgesic efficacy of local anesthetic wound instillation after surgical procedures associated with more extensive tissue damage is unknown. Because cesarean delivery and total abdominal hysterectomy (TAH) with bilateral salpingo-oophorectomy (BSO) are both performed through a Pfannenstiel incision, the somatic pain after these two procedures is probably similar. However, compared with cesarean delivery, TAH with BSO is associated with more extensive tissue damage (7). Thus, TAH with BSO is ideally suited to assess the postoperative analgesic efficacy of local anesthetic wound instillation after a surgical procedure associated with both somatic and visceral pain. Therefore, we performed a prospective, randomized, placebo-controlled, double-blinded study designed to assess the efficacy of bupivacaine wound instillation after TAH with BSO.
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Methods |
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Thirty-six ASA physical status I, II, and III patients undergoing TAH with BSO were enrolled into this IRB-approved, prospective, randomized, placebo-controlled, double-blinded study. In all cases, written informed consent was obtained before patient inclusion in the study.
Patients with a history of clinically significant cardiovascular, pulmonary, hepatic, renal, neurologic, psychiatric, or metabolic disease were excluded from the study. All perioperative data were collected by a coinvestigator who was blinded as to the patient randomization. In all cases, surgery was performed through a Pfannenstiel incision.
Before surgery, all patients were educated in the use of the patient-controlled analgesia (PCA) device. In the preanesthetic holding area, baseline 100-mm visual analog scales (VAS) (0 = minimal and 100 = maximal) were completed for pain, nausea, sleepiness, and anxiety.
No preanesthetic medication was administered. A standardized general anesthetic technique, consisting of IV fentanyl 7–10 µg/kg and thiopental 3–5 mg/kg for the induction and 0.5%–1.5% isoflurane (end-tidal) and 70% nitrous oxide in oxygen for the maintenance of anesthesia, was administered. Tracheal intubation was facilitated by succinylcholine 1.0 mg/kg IV, and surgical relaxation was maintained with IV vecuronium by using a peripheral nerve stimulator. After the induction of anesthesia, end-tidal CO2 concentration was monitored and the urinary bladder catheterized.
On completion of the operation, a multiorifice 20-gauge epidural catheter (B. Braun, Melsungen, Germany) was placed by the surgeon above the fascia with the catheter tip sited at the point that demarcated 50% of the length of the surgical wound and was secured on the skin with sterile tape. With use of an aseptic technique, the catheter was connected to the PCA device (GrasebyTM PCA Pump 3300; Graseby, Watford, Herts, UK). According to a computer-generated randomization schedule, the pump was filled with either 0.25% bupivacaine (Bupivacaine group) or an equal volume of sterile water (Control group). The PCA device was programmed to deliver 9 mL with a lockout time of 60 min and no basal infusion. Because of the physical characteristics of the catheter (i.e., resistance) and the PCA device (i.e., driving pressure), local anesthetic instillation was performed over a 5-min period. All patients received IM diclofenac 75 mg on conclusion of the surgical procedure and at 12-h intervals thereafter.
During the first 6 h after surgery, rescue morphine 2 mg IV was administered by a coinvestigator who was blinded to patient randomization. A VAS for pain >40 mm 20 min after initiating the PCA device constituted the trigger for rescue morphine administration. Thereafter, morphine 2 mg IV was administered at 10-min intervals until a pain score of 
30 mm was recorded. Patients were discharged from the postanesthesia care unit (PACU) 6 h after surgery. After PACU discharge, meperidine 1 mg/kg IM was administered upon patient request for additional analgesia. Perioperative nausea was treated with ondansetron 4 mg IV.
An investigator blinded to the study drug administered evaluated postoperative pain intensity on admission to the PACU, hourly for the first 6 h after surgery, and at 24 h after surgery. At these time intervals, the following variables were recorded: rescue analgesic drug requirements; VAS for pain at rest, on coughing, and after a 20-degree leg raise; VAS for nausea, sleepiness, and anxiety; and the number and volume of local anesthetic instillations.
Patients were interviewed 24 h after surgery and specifically asked about the occurrence of fever, nausea, vomiting, and drowsiness (with a scale of none, mild, moderate, or severe). In addition, by using a scale of poor, satisfactory, good, or excellent, patient satisfaction with their overall postoperative analgesia was recorded. On completion of the postoperative interview, by using aseptic technique, the catheter was removed, and the distal 5 cm was cultured for bacterial contamination. In addition, white cell count was monitored before the operation and on the third postoperative day.
Prestudy power analysis determined a sample size of 18 patients per group to have a 85% chance (ß = 0.15) for detecting a 3-mg difference in rescue morphine requirements during the first 6 h after surgery at the 95% confidence interval limitations (
= 0.05) (6).
Data are expressed as numbers, percentages, or mean ± SD or SEM. In all cases, normality was assessed with the Kolmogorov-Smirnov test (with the Lilliefors’ modification). Depending on the results of the Kolmogorov-Smirnov analysis, either parametric or nonparametric analysis was performed. Demographic and anesthetic data, as well as doses of drugs administered and white blood cell counts, were analyzed and compared by using Student’s t-test. The number of patients receiving rescue morphine, meperidine, and ondansetron, as well as the incidence of nausea, vomiting, dizziness, drowsiness, and fever, was analyzed by using Fisher’s exact test. The severity of the nausea and patient satisfaction were analyzed by using frequency table analysis. Pooled satisfaction results (excellent and good versus satisfactory and poor) were analyzed by using the Fisher’s exact test. The number of attempts to activate the PCA device and actual injections were analyzed with the Kruskal-Wallis test. Patient-generated VAS were analyzed with the Mann-Whitney U-test. In all cases, P < 0.05 was considered to be statistically significant.
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Results |
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The two study groups were demographically comparable. The mean age and weight were 48 ± 7 yr vs 47 ± 9 yr and 72 ± 16 kg vs 64 ± 10 kg for the Bupivacaine and Control groups, respectively. Furthermore, anesthetic time, surgery time, and the length of the surgical incision, as well as PACU and hospital admission times, were similar between the groups (Table 1). Intraoperative fentanyl administration was 8.5 ± 1.2 µg/kg vs 9.1 ± 1.3 µg/kg for the Bupivacaine and Control groups, respectively. All patients enrolled completed the study.
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The number of attempts to activate the PCA device was not affected by patient randomization. The actual numbers of pump infusions during the 24-h study period were 14 ± 4 and 10 ± 5 for the Bupivacaine and Control groups, respectively. The volume infused via the PCA device was 125 ± 38 mL versus 98 ± 39 mL for the Bupivacaine and Control groups, respectively (Table 2).
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Significantly (P < 0.001) less rescue analgesia was administered to patients in the Bupivacaine group when compared with the Control group. During the first 6 h after the operation, the total rescue morphine administered was 6 ± 4 mg vs 12 ± 6 mg (P < 0.001) for the Bupivacaine and Control groups, respectively. The total rescue meperidine administered during the next 18 h after surgery was 29 ± 37 mg vs 95 ± 36 mg (P < 0.001) for the Bupivacaine and Control groups, respectively (Table 2).
Resting pain scores were similar between the groups. However, at 4 h after the operation, pain scores after coughing and leg raise were significantly lower in the Bupivacaine group (P = 0.006 and P = 0.009, respectively) (Fig. 1).
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) and Control group (•) at the 95% confidence interval. *P = 0.006, **P = 0.009.During the first 6 h after surgery, the incidence of nausea and antiemetic treatment was significantly (P = 0.003) less in the Bupivacaine group compared with the Control group (44% vs 100%, respectively) (Table 3). However, during this time period, the incidence of anxiety and sleepiness was infrequent and similar between the groups.
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At the 24-h interview, all patients stated that the delivery system was easy to use. With the four-point satisfaction (for overall analgesia) score, no significant difference in patient satisfaction was noted. However, comparing excellent and good versus satisfactory and poor revealed that in the Bupivacaine group, a significantly (P = 0.04) larger number of patients described their satisfaction with their overall postoperative analgesia as excellent or good (Table 4). At 24 h after surgery, the incidence of fever, nausea, and sleepiness was similar between the groups. White cell counts before and on conclusion of the study were comparable between the groups. Finally, bacteriologic culture of the catheter tip was negative in all cases.
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Discussion |
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Patient-controlled local anesthetic wound instillation provides safe and effective postoperative analgesia after a variety of day-case operations, as well as cesarean delivery (5,6). However, before its widespread use for the treatment of postoperative pain, the factors affecting the analgesic efficacy of wound instillation must be rigorously investigated. First, the analgesic efficacy of local anesthetic wound instillation after surgical procedures associated with visceral and somatic pain is unknown. Second, the factors determining local anesthetic spread and the optimal site of drug administration (above or below the fascia) require further investigation. Third, the instillation volume and drug concentration may influence the success of this technique. Finally, the analgesic efficacy of wound instillation may be limited after surgical procedures performed through an extensive incision. To answer these questions, a stepwise series of prospective, randomized, controlled, double-blinded studies must be performed. Furthermore, for meaningful interpretation, each study must investigate a single variable.
Like cesarean delivery, TAH with BSO is performed through a Pfannenstiel incision. However, after incision and superficial dissection, tissue trauma during cesarean delivery is limited to the lower uterine segment. By contrast, TAH with BSO is associated with extensive surgical dissection and tissue damage. Therefore, we postulate that visceral pain constitutes the major postoperative difference between these two procedures. Considering the similarities and differences between these two procedures as well as the fact that wound instillation after cesarean delivery was associated with opioid sparing and improved patient comfort, we postulated that TAH with BSO is ideally suited to assess the analgesic efficacy of local anesthetic would instillation after procedures associated with significant somatic and visceral pain.
The results of our study indicate that after TAH with BSO, patient-controlled bupivacaine wound instillation decreases opioid requirements. Furthermore, the incidence of postoperative nausea and antiemetic drug administration was significantly less in the Bupivacaine group. Although the etiology of postoperative nausea and vomiting is multifactorial, we postulate that the decreased incidence of nausea and vomiting in the Bupivacaine group is probably caused by bupivacaine-induced opioid sparing.
It is interesting to note that pain scores were statistically similar between the groups. Furthermore, although pain scores generated on coughing and leg raise were lower in the Bupivacaine group, a statistical difference was reached only during the fourth postoperative hour. These findings are probably multifactorial. First, the trigger for rescue morphine administration was based on subjective pain perception. Second, rescue morphine was administered when a VAS for pain >40 mm was recorded 20 minutes after wound instillation. Thereafter, rescue morphine was administered at 10-minute intervals until a pain score of 30 mm was recorded. We postulate that the criteria by which rescue morphine was administered decreased the sensitivity of the pain scores as a measure of the analgesic efficacy of bupivacaine wound instillation and resulted in equilibration of the patient-generated pain scores.
The relative contribution of somatic and visceral pain after abdominal surgery is unknown and difficult to elucidate (8). As a result, the mechanism by which bupivacaine wound instillation decreased postoperative pain and opioid requirements in our study is unclear. It is possible that pain of somatic origin is the major cause of discomfort after TAH with BSO. However, previous studies have demonstrated that local anesthetic wound infiltration does not decrease postoperative opioid requirements or improve patient comfort (9,10). Although repeated bupivacaine wound instillation may simply be better than single injections at relieving somatic pain, it is also possible that the technique decreases both somatic and visceral pain. Somatic pain is attenuated because, after local anesthetic infiltration into the surgical wound, these drugs modulate peripheral pain transduction by inhibiting the transmission of noxious impulses from the site of injury (11). However, the mechanism by which local anesthetics attenuate noxious impulses generated by visceral tissues distant to the site of drug infiltration is more difficult to explain. Systemic absorption of local anesthetic drugs may induce a systemic analgesic effect (12–14). This hypothesis is supported by the observation that, when administered systemically to decerebrated animals, local anesthetics decrease dorsal horn neuronal excitability (15,16). Certainly our technique leads to significant systemic levels of local anesthetic. After repeated ropivacaine wound instillation for the treatment of postcesarean delivery pain, systemic blood ropivacaine accumulation was noted in a time-dependent manner (6). It is possible that repeated local anesthetic wound instillation decreases injury-induced C-fiber activity with consequent attenuation of peripheral and central sensitization (8,17–19). The relative contribution of each of these mechanisms by which repeated local anesthetic instillation decreases visceral afferent input requires further investigation.
When analyzing the suitability of a new treatment regimen, it is important to consider both its therapeutic efficacy and the incidence of possible unwanted side effects. Although there seems to be no association between local anesthetic wound instillation and neurotoxicity or catheter-related infection (6), it should be remembered that all local anesthetics are myotoxic (20,21). In addition, myonecrosis may occur after the IM injection of local anesthetics or their injection into surrounding subcutaneous tissue (22–24). However, the extent of muscle injury is directly related to the dose and number of drug administrations (21,25). Although experimental myotoxic responses are both intense and reproducible, in the clinical setting local anesthetic-induced myotoxicity seems to be rare (26), probably because local anesthetic-induced analgesia and anesthesia is achieved at a dosage insufficient to produce clinically recognizable myotoxicity. Conversely, because experimental studies show myonecrosis after single injections of small dosages of local anesthetics, it is possible that myotoxicity occurs but is not recognized because of rapid and complete muscle cell recovery. In our study, myotoxicity was not specifically assessed. However, considering our study design, this complication is unlikely. First, only 9 mL/h of bupivacaine (0.25%) was administered. Second, the local anesthetic was not injected directly into muscle or subcutaneous tissue.
Few studies have evaluated the analgesic efficacy of wound instillation after TAH with BSO. In a study by Kristensen et al. (12), instillation catheters were placed between the muscle layer and peritoneum. Thereafter, bolus injections of bupivacaine (15 mL of a 2.5 mg/mL solution) were administered every four hours for 48 hours after surgery. However, unlike in our study, bupivacaine administration did not decrease pain or analgesic requirements when compared with control. We postulate that the dosage, timing of bupivacaine administration, and site of catheter placement contributed to these negative results. Furthermore, analgesia was not patient controlled.
This study may be criticized in that during the 6- to 24-hour follow-up period, pain intensity was mea-sured and compared by using rescue narcotic requirements rather than VAS for pain. However, it was considered ethically unacceptable to wake a sleeping postoperative patient to measure pain perception. Furthermore, VAS reflects pain perception only at the time of measurement. Because pain and discomfort will spontaneously disturb sleep, we suggest that narcotic usage during this follow-up period is an acceptable alternative to a VAS measured according to a protocol-determined time scale. A second criticism relates to the fact that patient follow-up was stopped 24 hours after surgery. However, the aim of this study was to evaluate the analgesic efficacy of wound instillation during the immediate postoperative period. Having established that this technique decreases postoperative pain after TAH with BSO, the influence of wound instillation on intermediate and long-term outcome requires further investigation.
We conclude that patient-controlled bupivacaine wound instillation via a PCA device decreases postoperative nausea and narcotic usage in the first 24 h after TAH with BSO.
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