Day-case laparoscopy: a comparison of prophylactic opioid, NSAID or local anesthesia for postoperative analgesia

Acta Anaesthesiol Scand 2000; 44: 536–542 Printed in Denmark. All rights reserved

Copyright C Acta Anaesthesiol Scand 2000 ACTA ANAESTHESIOLOGICA SCANDINAVICA

ISSN 0001-5172

Day-case laparoscopy: a comparison of prophylactic opioid, NSAID or local anesthesia for postoperative analgesia ¨ . AYPAR M. A. SALMAN, M. ERCAN YU¨CEBAS¸, F. COS¸KUN and U

Department of Anesthesiology and Reanimation, Hacettepe University Faculty of Medicine, Ankara, Turkey

Background: The study was aimed to evaluate the analgesic efficacy, postoperative comfort, recovery characteristics and side effects of three different analgesic agents administered prophylactically. Methods: Eighty patients undergoing day-case minor operative laparoscopy were randomly allocated into four groups to receive tenoxicam 20 mg i.v. (Group T), fentanyl 100 mg i.v. (Group F), 5 ml of bupivacaine 2.5 mg/ml for infiltration of trocar sites (Group B), 30, 10 and 5 min before incision respectively. Bupivacaine, 35 ml, 2.5 mg/ml was also administered into the pelvic cavity in Group B. Group P received only placebo. Postoperative pain, analgesic requirements, first response to verbal stimulus, first analgesic requirement, ability to walk without help, to drink and to void, blood pressures, SpO2 and respiration rates were recorded in the PACU. Postoperative pain was evaluated by verbal rating scale. Pain scores, analgesic requirements and side effects were evaluated by telephone calls until the 48th postoperative hour. Results: Postoperative pain scores were lower and time to re-

quirement of rescue analgesics was longer in groups F and B compared to Group P. In the PACU, analgesic requirements were lower in Group B, compared to Group P. Nausea and vomiting were increased in Group F. Conclusion: Tenoxicam 20 mg i.v. was found to be ineffective whereas bupivacaine was superior to other groups in reducing pain and analgesic requirements. Bupivacaine also increased time to first analgesics and obtained better recovery characteristics, underlining its value in prophylactic pain management compared to the other two agents.

A

increased perception of subsequent postoperative pain. The optimal management of pain must therefore include pain treatment before, during and after the operation. The aim of the present study was to evaluate the analgesic efficacy, postoperative comfort, recovery characteristics, need of rescue analgesics and the side effects of three different agents, an opioid, a non-steroidal anti-inflammatory drug (NSAID) and a local anesthetic, used for preventing postoperative pain.

majority of laparoscopic operations, especially the ones for diagnostic purposes, are performed on a day-case basis. Even though pain after laparoscopy is less severe and shorter than pain after laparotomy, the early discharge of the patient is possible only when postoperative pain is effectively controlled. Pain after laparoscopy may be associated with the distension of vessels and nerves secondary to the distension of the peritoneum and irritation of the phrenic nerve (1). Numerous methods have been used such as systemic analgesics, local anesthesia or regional blocks for the treatment of postoperative pain. Even though effective analgesics are available, 30–70% of patients suffer severe postoperative pain (2). On demand intramuscular (i.m.) opioids do not produce adequate postoperative analgesia in a great majority of patients and they also prolong the recovery period (2, 3). Recently, advances in the pathophysiology of pain has pointed out the theory of central sensitization (4, 5). According to this theory, initial sensitization of the central nervous system (CNS) results in GREAT

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Received 21 April, accepted for publication 15 November 1999

Key words: Surgery, outpatient; surgical procedures, laparoscopic; pain, postoperative; analgesics, opioid, fentanyl; anti-inflammatory agents, non-steroidal, tenoxicam; anesthetics, local, bupivacaine. c Acta Anaesthesiologica Scandinavica 44 (2000)

Methods After approval of the local ethics committee, informed consent was obtained from 80 ASA I or II patients planned to undergo minor operative laparoscopy under general anesthesia. Patients with a history of bronchial asthma, peptic ulceration, clinically significant cardiovascular, renal, hepatic diseases, allergy to any of the drugs to be used in the study and patients with bleeding disorders were excluded from the study. No premedication was

Prophylactic analgesia for laparoscopy

used; 500 ml of intravenous (i.v.) normal saline was administered preoperatively. The age, weight and day of menstrual cycle of the patients were recorded. A verbal rating scale (VRS) ranging from 0 to 10 was described to the patients. Since some patients suffered preoperative pain, basal pain scores were recorded. The patients were allocated to one of the four study groups consisting of 20 patients each, according to a table of random numbers. The patients in the first group (Group P) received 2 ml solvent of tenoxicam (TilcotilA, Roche) as an i.v. placebo, 30 min before incision and 2 ml i.v. normal saline 10 min before incision. Before surgical incision, sites of trocars were infiltrated with a total of 5 ml saline 5 min before incision and 35 ml intraperitoneal (i.p.) normal saline was administered into the pelvic cavity, when the patient was in the supine position. The patients in the second group (Group T) received tenoxicam (TilcotilA, Roche), 20 mg i.v. 30 min before incision and the third group (Group F) received fentanyl citrate (FentanylJanssen), 100 mg i.v. 10 min before incision instead of placebo. The patients in the last group (Group B) received 5 ml of bupivacaine hydrochloride diluted to 2.5 mg/ml (MarcaineA 0.5%, Eczacıbas¸ı-Astra) for infiltration of trocar sites and 35 ml bupivacaine diluted to 2.5 mg/ml and applied into the pelvic cavity. The anesthesiologists performing injections, recording data and the surgeon performing infiltrations were blinded to the contents of injectors previously labeled by another anesthesiologist. Anesthesia was induced with propofol (DiprivanA, Zeneca), 2 mg/kg i.v. and atracurium besilate (TracriumA, Wellcome), 0.5 mg/kg i.v. Endotracheal intubation was performed in all cases. Anesthesia was maintained with 60% nitrous oxide in oxygen and 1% isoflurane. All operations were performed by the same surgeon. Carbon dioxide was used for establishment of pneumoperitoneum. After the termination of pneumoperitoneum, carbon dioxide was expelled, as much as possible, from the principal trocar with the help of brief pressure on the abdomen. Any residual muscle relaxation was antagonized with atropine sulfate (Atropin Su¨lfat, Haver), 0.5 mg i.v. and neostigmine (ProstigmineA, Roche), 50 mg/kg i.v. The patients were transferred to the postanesthesia care unit (PACU) when their spontaneous ventilation caused no desaturation after extubation. The time from induction to extubation was recorded as anesthesia time. The time from skin incision to end of the operation was recorded as operation time. In the PACU, non-invasive blood pressures, respiration rates and oxygen saturations of hemoglobin measured by pulse oximeter (SpO2) were monitored.

The time of the patients’ first response to verbal stimulus, first analgesic requirement, ability to walk without help, to drink and to void were recorded by the same anesthesiologist, who was blinded to the prophylactic analgesic treatment of the patients. The patients were assessed at the 30th minute, and the 1st, 2nd, 3rd and 6th hour after operation. At each assessment they were asked if they had nausea, vomiting or any pain. If they had pain they were asked to rate their pain according to the VRS. They were then asked if they required ‘‘pain relief medication’’. The patients with VRS scores over 5 and demanding medication were administered morphine sulfate, 3 mg i.v. The patients with VRS scores less than 5 but demanding medication were administered metamizol (NovalgineA, Hoechst), 1 g i.v. The time from first response of the patient to verbal stimuli to the first analgesic requirement was recorded as conscious analgesia time. The patients demanding analgesics between assessment times were also administered analgesics according to the same analgesic protocol. Additional analgesics were not administered at intervals less than 20 min. Non-invasive mean blood pressures, respiration rates and SpO2 were also recorded at each assessment. The patients were discharged from the PACU after gaining the ability to drink without vomiting, to void and to walk without any or with only minor help. At the postoperative 3rd hour the patients were asked if they had vomited, suffered any shoulder pain or nausea. Total amount of analgesics used in the PACU was recorded. Analgesic scores were obtained according to total dose of i.v. analgesics required in the PACU. The patients that required no analgesics scored 0, those who received 1 g of metamizol scored 1, 3 mg of morphine sulfate scored 2, 1 g of metamizol and 3 mg of morphine sulfate scored 3 and those who received 6 mg of morphine sulfate scored 4. The patients were prescribed oral ibuprofen 400 mg (BrufenA, Atabay-Boots Pharmaceuticals) on demand, with instructions to take one pill at a time with minimum intervals of two hours and a maximum daily dose of 6 pills (2400 mg). The patients were contacted by telephone at postoperative 24th and 48th hours and their pain scores (VRS), existence of shoulder pain, nausea, vomiting, analgesic dose used and other side effects that may have occurred were asked. The patients were reminded that they would be contacted by telephone upon discharge from the hospital. The patients discharged before the 6th postoperative hour were instructed to write down their VRS scores at the 6th postoperative hour in order to be obtained via the telephone call at the 24th postoperative hour. Sample size was based on power analysis with two-

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M. A. Salman et al. Table 1

Results

Demographic data (mean∫SD).

Group Group Group Group Total

P T F B

Age (years)

Weight Anesthesia Operation Preoperative (kg) time (min) time (min) VRS scores

29∫7.0 31∫7.6 30∫6.0 30∫7.0

60∫7.1 53∫9.9 62∫11.5 61∫8.2

29∫13.4 31∫17.7 30∫17.0 30∫12.1

24∫12.9 26∫16.7 25∫16.2 25∫11.7

0.25∫0.55 0.05∫0.22 0.05∫0.22 0.20∫0.52

30∫6.8

60∫9.2

30∫15.0

25∫14.2

0.14∫0.41

tailed a value of 0.05, b of 0.15, a difference in VRS scores of 3 and a standard deviation of 2.2. Data were analyzed using SPSS for Windows program release 6.0 on an IBM compatible PC. Data were first tested by Kolmogorov-Smirnov goodness-of-fit test. Data with normal distribution were analyzed by one-way ANOVA and post hoc independent groups t-tests, whereas Kruskal-Wallis one-way ANOVA and post hoc MannWhitney U-Wilcoxon Rank sum tests were used for data without normal distribution. Frequencies of complications were compared with Pearson’s Chi-square test. Consecutive measurements from the same patient were analyzed using multivariate repeated measures analysis of variance, where applicable. P values less than 0.05 were accepted as significant for analysis of variance. A downward adjustment of a level was performed in order to compensate for the multiple post hoc comparisons.

The ages, weights, anesthesia and operation time of the four groups were similar (Table 1). Preoperative VRS scores were not different in the four groups. The patients also demonstrated similar distribution regarding their menstrual cycle days in the four study groups. In groups B, F and T, pain scores were lower than the placebo group in the postoperative period but these differences were not always statistically significant. In Group F, VRS scores were significantly lower than the placebo group in the postoperative 1st, 2nd and 3rd hours. In Group B, patients’ VRS scores were significantly lower than the placebo group till the 48th postoperative hour. Even though pain scores were reduced compared to placebo in group T, these data were not statistically significant (Fig. 1). Intravenous analgesics were not required in 6 patients in Group P (30%), 8 patients in Group T (40%), 8 patients in Group F (40%) and 14 patients in Group B (70%). Analgesic scores, which indicate the analgesics required in the first 3 h postoperatively were also found to be lower in Group B compared to Group P. Time to first analgesic requirements was significantly longer in groups B and F compared to both Group P and Group T. The conscious analgesia time was longer in groups B and F compared to Group T and Group P (Table 2). In the postoperative period 3–48 h patients in Group F had suffered nausea at higher frequencies

Fig. 1. Mean Verbal Rating Scale Scores, * P⬍0.008 compared to Group P.

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Prophylactic analgesia for laparoscopy Table 2 Early postoperative analgesia time and postoperative analgesic requirements (mean∫SD). Group P Time to first analgesic (min) Conscious analgesia time (min) Number of patients with no i.v. analgesic requirements in PACU Analgesic score Morphine requirement in the first postoperative 3 h (mg) Metamizol requirement in the first postoperative 3 h (gr) Ibuprofen requirement on the first postoperative day (pills) Ibuprofen requirement on the second postoperative day (pills) * P⬍0.008 compared to Group P;

†

21.0∫14.3 14.0∫14.4 6 1.4∫1.1 5.4∫5.4 0.2∫0.4 2.9∫0.8 2.0∫0.6

Group T 17.3∫8.5 6.3∫8.8 8 1.1∫1.2 3.6∫5.4 0.3∫0.5 2.6∫1.6 2.3∫1.6

Group F

Group B †

48.3∫34.5* 40.8∫35.7*† 8 1.4∫1.3 5.8∫6.0 0.1∫0.3 2.3∫1.7 2.6∫1.8

48.3∫24.6*† 42.5∫25.4*† 14 0.5∫0.8* 1.8∫3.7 0.1∫0.3 2.1∫1.2 1.5∫1.1

P⬍0.008 compared to Group T.

Table 3 Postoperative nausea, vomiting and shoulder pain (number and percentage of patients with complications in each group). Group P Nausea in the first postoperative 3 h Nausea in the postoperative period 3–48 h Vomiting in the first postoperative 3 h Vomiting in the postoperative period 3–48 h Shoulder pain in the first postoperative 3 h Shoulder pain in the postoperative period 3–48 h * P⬍0.008 compared to Group P;

.

12 6 3 0 6 18

Group T (20%) (5%). (10%) (5%) (15%) (70%)

Group F

(60%) (30%) (15%) (0%). (30%) (90%)

4 1 2 1 3 14

12 11 8 10 1 20

(60%) (55%) (40%) (50%)* (5%) (100%)

Group P

Group T

Group F

Group B

7.7∫2.3 390∫80 356∫111 603∫328

7.8∫3.4 401∫149 293∫130 662∫851

9.2∫6.7 490∫303 473∫390 436∫334

4.9∫2.7*.† 388∫189 288∫222*. 277∫386*†

Group B 6 4 1 2 3 16

(30%) (20%) (5%) (10%) (15%) (80%)

P⬍0.008 compared to Group F.

Table 4 Recovery characteristics (mean∫SD).

Response to verbal stimuli (min) Oral intake time (min) Voiding time (min) Walking time (min) * P⬍0.008 compared to Group P;

.

P⬍0.008 compared to Group F;

compared to patients in Group T (Table 3). Vomiting occurred in a higher percentage of patients in Group F than the other groups, being significant when compared to Group P in the postoperative period 3–48 h. No significance was observed in shoulder pain frequencies among the four groups in the postoperative period. Recovery characteristics are listed in Table 4. Time from the end of anesthesia to the first response to verbal stimuli was found to be significantly shorter in Group B than the other three groups. Time to first oral intake that could be tolerated was not statistically different in the study groups. Time to the first postoperative voiding was increased in Group F; however, voiding time in Group F was found to be significantly longer only than Group B. Group B patients were also

†

P⬍0.008 compared to Group T.

able to void sooner than the placebo group. Time to walking without help was found to be significantly reduced in Group B patients compared to groups P and T. In the first postoperative 3 h when the patient was monitored in the PACU, respiration rates and arterial oxygen partial pressures measured by pulse oximeter were not significantly different among the patients in different study groups. Mean blood pressure was found to be slightly increased in the placebo group, constituting a statistical significance (Table 5).

Discussion The scientists and clinicians studying the pathophysiology of acute pain have gained a new view which

539

M. A. Salman et al. Table 5 Mean blood pressures, mmHg (mean∫SD).

Preoperative Postoperative 30th minute Postoperative 1st hour Postoperative 2nd hour Postoperative 3rd hour

Group P

Group T

Group F

Group B

94∫11

98∫16

90∫10

96∫13

86∫8 87∫8 89∫7 93∫6

81∫8 79∫6* 79∫7* 83∫11*

80∫5* 80∫6* 81∫6* 85∫7*

82∫9 83∫11 82∫8* 84∫11*

* P⬍0.008 compared to Group P.

implies that pain does not arise from the activation of a unique pain system but it is an expression of dysfunction in the somatosensory system. According to experimental data, the nociceptive impulses that are brought to the central nervous system (CNS) by the C fiber afferents produce long-lasting changes of the dorsal horn neurons (4). A noxious stimulus can change the excitability of these neurons and alter their receptive field properties. High doses of analgesics are required in order to suppress this state whereas small doses of analgesics administered before central sensitization may be effective in reducing the subsequent pain effectively. This may explain the reason for longer postoperative analgesic effects of preoperatively administered analgesics. In our study, 100 mg of fentanyl administered preoperatively reduced VRS scores of the patients up to 3 h postoperatively, which is beyond the effect of a low single dose of this drug. The same effect was demonstrated with the use of bupivacaine, which was found to reduce the VRS scores of the patients up to the 48th postoperative hour compared to placebo. However, 20 mg of i.v. tenoxicam did not reduce the VRS scores compared to placebo. In all of the postoperative assessments, VRS scores of the patients in Group T were lower than those in Group P, but these differences were not statistically significant. NSAIDs are used widely in day-case surgery, solely or as adjutants in reducing opioid requirements (2, 6– 9). Laparoscopic tubal manipulation may release prostaglandins, which are found in human oviduct and ovarian follicle in high concentrations. Prostaglandins may lead to an increase in nociceptive impulses and result in pain (1). This pain may be controlled by prostaglandin synthase inhibitors. The postoperative analgesic efficacy of numerous NSAIDs have been demonstrated in many studies in laparoscopic operations. Tenoxicam is an oxicam class NSAID with a long half-life of plasma concentration (72 h) (10). Although its pre-emptive role in day-case surgery have been demonstrated by Colbert et al., it

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has not been studied in laparoscopy as yet (3). Tenoxicam 20 mg i.v. did not show a significant effect in reducing postoperative pain in our study. This finding is consistent with the study of Windsor et al. (11). However, in a study by Munro et al. the patients received 40 mg of tenoxicam i.v. on skin closure following laparoscopic cholecystectomy and a significant reduction in postoperative morphine consumption was determined (26). Since tenoxicam has a long half-life, it may be expected to reach effective plasma levels after several doses. We used the single 20 mg dose following the recommendation of the manufacturers, but this dose may not be enough to demonstrate a significant postoperative analgesic effect of the drug. Although the drug was administered intravenously in our study in order to avoid any delay in obtaining higher plasma concentrations, higher loading doses rather than the 20 mg may be required to reach effective plasma concentrations due to its long half-life. Our study was performed on 80 patients divided into four groups and this setting has the power to demonstrate a difference of 3 or more on the VRS. Studies performed on larger patient groups may be able to demonstrate a significant analgesic effect of the drug that we failed to demonstrate with our sample size. Further studies are warranted in determining the efficacy of tenoxicam in postoperative analgesia. Time to first analgesic and conscious analgesia time were significantly longer statistically in groups B and F compared to both Group P and Group T. Longer analgesic free periods were also observed in the studies by Kiss and Kilian and Ke et al. (12, 13). However, the significance of these data in our study are reduced by the fact that many patients did not require any analgesic at all in the PACU. This reduced the size of the groups to be compared, thus diminishing the power of the statistical analysis. Local anesthetics, administered both i.p. and in infiltration of the incision sites, are being used for the treatment of postoperative pain in laparoscopies (1, 14–16). Bupivacaine has a long effect and is effective in reducing especially the postoperative shoulder pain in laparoscopic operations. Even though it possesses toxic properties, its i.p. use has been found to be safe in laparoscopic surgeries (14, 16). Only bupivacaine was found to reduce the postoperative i.v. analgesic requirements in the three analgesic treatment groups compared to placebo in our study. We found i.v. fentanyl and wound infiltration and i.p. administration of bupivacaine effective in decreasing postoperative pain. These findings are consistent with data obtained in various studies (12, 13, 17–21). Postoperative nausea and vomiting (PONV) are fre-

Prophylactic analgesia for laparoscopy

quently observed complications of laparoscopic surgery. Female patients are reported to have higher incidence of PONV than males and the highest incidence of PONV (54%) is reported in gynecologic laparoscopy (22). Postoperative nausea and vomiting in gynecologic laparoscopy is also associated with the day of the menstrual cycle of the patients (23). Since opioids are known to be associated with higher incidences of PONV, care must be taken in order to reduce this complication. NSAIDs are associated with less PONV in their perioperative use (6). In our study we observed a higher incidence of nausea in Group F compared to Group T. This is consistent with the findings of Chia and Liu (24). Vomiting was also found to be more frequent in Group F compared to the other three groups, resulting in a statistical significance compared to placebo only in the period between the postoperative 3rd and 48th hours. Shoulder pain incidence did not show any significant difference among the groups till the postoperative 48th hour. Shoulder tip pain is reported to be lower with the application of intraperitoneal bupivacaine to the subdiaphragmatic region (20, 21). However, irrigation of the pelvic cavity with bupivacaine did not reduce the incidence of shoulder pain in our study, even though it was found effective in reducing overall pain scores. Early discharge of the patient is important in the rational utilization of the medical staff, OR and PACU facilities. The patients in Group B were found to have shorter time to first response to verbal stimuli. Ability to void and to walk without help were also found to be gained sooner in group B patients. No difference was observed in respiratory rates and SpO2 in the PACU among the four groups. The slight increase in MAP in group P was well correlated with the higher pain scores in this group, probably leading to the activation of the sympathetic system in combination with the effect of high intraabdominal pressures during pneumoperitoneum (25). However, this statistically significant difference does not imply any clinical importance. In conclusion, while prophylactic tenoxicam, 20 mg i.v., was ineffective in reducing pain or analgesic requirements, fentanyl was found effective in reducing pain and increasing time to first analgesic requirement after laparoscopy. Bupivacaine, in the doses we used, was found to be superior to the other two drugs in reducing pain, decreasing analgesic requirements, increasing time to first analgesics, and obtaining better recovery characteristics and is thus a valuable agent in the management of pain following operative laparoscopy.

Acknowledgement The authors would like to thank Dr. Sibel Kahraman for her valuable criticism and comments on the manuscript.

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Address: M. Alper Salman M.D. Department of Anesthesiology and Reanimation Hacettepe University Faculty of Medicine Hacettepe Ankara TR-06100, Turkey