|Year : 2017 | Volume
| Issue : 3 | Page : 256-261
“Comparison of preincisional port site infiltration of 0.5% levobupivacaine versus 0.5% ropivacaine for postoperative pain relief in patients undergoing laparoscopic appendicectomy: A one year hospital-based double-blind randomized controlled trial”
Santosh Subarao Patil, Vandana A Gogate
Department of Anaesthesiology, KLE University's Jawaharlal Nehru Medical College; KLE Dr. Prabhakar Kore Hospital and MRC, Belagavi, Karnataka, India
|Date of Web Publication||5-Sep-2017|
Santosh Subarao Patil
C/O S. B. Khot, Plot No - 97, Sector No – 01, M. M. Extension, Ramnagar, Belagavi - 590 010, Karnataka
Source of Support: None, Conflict of Interest: None
Introduction: Administration of local anesthetic into the wound before incision has been found to reduce postoperative pain following laparoscopic surgery. Levobupivacaine and ropivacaine which are less cardiotoxic and neurotoxic than bupivacaine are being used for local infiltration.
Objective: To compare the efficacy of preincisional port site infiltration of 0.5% levobupivacaine versus 0.5% ropivacaine for postoperative pain relief in patients undergoing laparoscopic appendicectomy.
Methodology: By computer-generated randomization table, sixty adult patients undergoing elective laparoscopic appendicectomy under general anesthesia were divided into two groups. Group 1 patients received 14 mL of 0.5% levobupivacaine preincisional port site infiltration and Group 2 patients received 14 mL of 0.5% ropivacaine preincisional port site infiltration, 6 mL at the umbilical port, and 4 mL at each working port. In the postoperative period, anesthesia resident blinded to the drug used assessed for postoperative pain at 0, 1, 2, 3, 4, 5, 6, 10, 14, 18, and 24 h using visual analog scale (VAS) pain scale. If VAS >3 rescue analgesia in the form of injection tramadol 2 mg/kg intravenous (IV) was given. Time of first rescue analgesia as well as total opioid consumption at the end of 24 h was noted.
Results: The mean VAS scores were comparable in both the groups at different time intervals postoperatively (P > 0.05). The total amount of rescue analgesic consumed over 24 h in the form of injection. Tramadol IV was 126 ± 14.76 in Group 1 and 122 ± 12.77 in Group 2 and was comparable (P = 0.641).
Conclusion: Preincisional port site infiltration with both 0.5% levobupivacaine and 0.5% ropivacaine is equally effective in providing pain relief.
Keywords: 0.5% levobupivacaine, 0.5% ropivacaine, laparoscopic appendicectomy, postoperative pain, preincisional port site infiltration
|How to cite this article:|
Patil SS, Gogate VA. “Comparison of preincisional port site infiltration of 0.5% levobupivacaine versus 0.5% ropivacaine for postoperative pain relief in patients undergoing laparoscopic appendicectomy: A one year hospital-based double-blind randomized controlled trial”. Indian J Health Sci Biomed Res 2017;10:256-61
|How to cite this URL:|
Patil SS, Gogate VA. “Comparison of preincisional port site infiltration of 0.5% levobupivacaine versus 0.5% ropivacaine for postoperative pain relief in patients undergoing laparoscopic appendicectomy: A one year hospital-based double-blind randomized controlled trial”. Indian J Health Sci Biomed Res [serial online] 2017 [cited 2019 Jun 17];10:256-61. Available from: http://www.ijournalhs.org/text.asp?2017/10/3/256/214004
| Introduction|| |
It is well known that laparoscopic surgeries cause less postoperative pain, allow early ambulation and discharge, than open surgeries.,, However, laparoscopic surgery is not completely pain free.
Administration of local anesthetic (LA) into the wound before incision (preemptive analgesia) has been found to reduce postoperative pain in laparoscopic surgeries., Bupivacaine is a commonly used LA for local infiltration but is associated with cardiovascular and neurotoxicity. To overcome this shortcoming, levobupivacaine and ropivacaine which are less cardiotoxic and neurotoxic when compared to bupivacaine are being used in regional anesthesia., However, very few studies have compared levobupivacaine and ropivacaine.
| Methodology|| |
The present study, a 1-year double-blind randomized controlled trial, was conducted at a tertiary care hospital on patients undergoing laparoscopic appendicectomy under general anesthesia between January 2015 and December 2015.
A total of sixty patients were included in the study, thirty in each group.
The inclusion criteria were as follows:
- American Society of Anesthesiologists (ASA) Grade I and II
- Age between 18 and 60 years
- Patients undergoing laparoscopic appendicectomy under general anesthesia.
The exclusion criteria were as follows:
- Patients not willing to give consent
- Patients with known allergic reactions to LAs
- Patients in whom time from port site infiltration to endotracheal extubation is more than 2 h.
After obtaining approval from the Ethical Committee and written informed consent from patients satisfying inclusion and exclusion criteria, sixty adult patients undergoing elective laparoscopic appendectomy were included in the study.
A thorough preanesthetic evaluation was done. Investigations such as complete blood count, random blood sugar, blood urea, and serum creatinine were advised. Chest radiography and electrocardiography (ECG) were advised if the patient was more than 40 years of age. Patients were advised overnight fasting, and procedure was explained. Patients were divided into two groups by computer-generated randomization table, Group 1 and Group 2.
Under strict aseptic precaution, 18- or 20-gauge intravenous (IV) cannula was secured. The patient was shifted into the operation theatre (OT), and standard monitors such as pulse oximeter, noninvasive blood pressure, and ECG were connected. Intraoperative vital parameters were recorded and maintained within normal limits.
Following preoxygenation, the patient was premedicated with injection glycopyrrolate 0.005 mg/kg IV, injection midazolam 0.05 mg/kg IV, and injection pentazocine 0.5 mg/kg. Induction of anesthesia was done with injection thiopentone sodium 5 mg/kg IV sufficient to obtund the eyelash reflex, followed by injection vecuronium 0.1 mg/kg IV. Tracheal intubation was performed by an experienced anesthesiologist with an appropriate-sized endotracheal tube. Immediately, after intubation, cuff of the endotracheal tube was filled with a volume of room air required to prevent a palpable air leak. Anesthesia was maintained with 0.5 MAC halothane and vecuronium and supplemented with oxygen 33% in nitrous oxide. Intracuff pressure was maintained throughout the procedure to prevent palpable air leak.
The patient was painted with povidone iodine and surgical spirit sequentially. Parts draped. Study drug was prepared in identical 20 mL syringes by an anesthesia resident containing 14 mL of the study drug. An anesthesiologist who is blinded to the study drug infiltrated the drug at the port site before the ports were inserted, 6 mL at the umbilical port and 4 mL at each working port under strict aseptic precautions. Laparoscopic appendectomy was done according to standard protocol, by a well-trained surgical team. Intraoperative vitals recorded. Residual neuromuscular relaxation with vecuronium was antagonized with injection neostigmine IV (0.05 mg/kg body weight) and injection glycopyrrolate IV (0.01 mg/kg body weight) on completion of surgery.
In the postoperative period, anesthesia resident blinded to the drug used assessed for postoperative pain at 0, 1, 2, 3, 4, 5, 6, 10, 14, 18, and 24 h using visual analog scale (VAS) pain scale. If VAS >3 rescue analgesia in the form of injection tramadol 2 mg/kg was given. Total opioid consumption at the end of 24 h was noted. Adverse effects if any of LAs as well opioids were noted.
The data were entered into the Microsoft Excel spreadsheet. The data were analyzed using SPSS statistical software version 20.0 (IBM Corp. Released 2013. IBM SPSS Statistics for Windows, Version 22.0. Armonk, NY: IBM Corp.). Student's unpaired t-test was used to compare quantitative variables in both groups, and the qualitative variables were compared using student's paired t-test for each group independently. The categorical data are compared using Chi-square test. Nonparametric data were analyzed using Mann–Whitney Test. All data were expressed as mean ± standard deviation. A probability (“ P” value) of ≤0.05 at 95% confidence interval was considered as statistically significant.
| Results|| |
In our study, we found no statistically significant difference between Group 1 and Group 2 with regard to mean age (38.1 ± 10.44 and 36.9 ± 11.54 years, respectively; P = 0.650), mean weight (63.2 ± 7.70 and 61.7 ± 6.02 kg, respectively; P = 0.415), mean height (163.1 ± 7.13 and 162.5 ± 7.81 cm, respectively; P = 0.783) [Table 1], percentage of male and female [Table 2] ASA physical Status I (70% and 73.33% patients, respectively), and ASA Grade II (30% and 26.66% patients, respectively) [Table 3].
In our study, the mean VAS score at 0th h postoperatively was 1.56 ± 1.91 in Group 1 and 1.56 ± 2.07 in Group 2 and was comparable (P = 0.837).
The mean VAS score at 1st h postoperatively decreased to 1.1 ± 1.18 in Group 1 and 0.83 ± 1.01 in Group 2 and was comparable (P = 0.424). The mean VAS score further decreased and at 6th h postoperatively was 0.53 ± 0.73 in Group 1 and 0.7 ± 0.95 in Group 2 and was comparable (P = 0.661). The mean VAS score further decreased to 0.1 + 0.31 in Group 1 and 0.2 ± 0.41 in Group 2, 24th h postoperatively and was comparable (P = 0.282).
Hence, the mean VAS scores were comparable in both the groups [Table 4] and [Graph 1].
In our study, five patients out of thirty in Group 1 and six patients out of thirty in Group 2 required rescue analgesia. The number of patients who required rescue analgesia was comparable in both the groups (P = 0.843). The maximum VAS score recorded was 6 in both the groups and was identical [Table 5] and [Graph 2].
In our study, the total amount of rescue analgesic consumed over 24 h in the form of injection tramadol IV was 126 ± 14.76 in Group 1 and 122 ± 12.77 in Group 2 and was comparable (P = 0.641) [Table 6] and [Graph 3].
In our study, the total duration of surgery was 99.83 ± 8.42 in Group 1 and 97.46 ± 8.25 in Group 2 and was comparable in both the groups (P = 0.276) [Table 7] and [Graph 4].
| Discussion|| |
Acute appendicitis is the common gastrointestinal emergency encountered in adults. As compared to open techniques, laparoscopic surgeries involving multiple small incisions results in less postoperative pain, faster recovery, and early discharge from the hospital which enables early resumption of routine activities by the patient.,,
However, laparoscopic surgeries are not pain free. Pain after laparoscopic surgeries results from port site incision, stretching of the parietal peritoneum, peritoneal inflammation, and phrenic nerve irritation caused by residual carbon dioxide in the peritoneal cavity. Various modalities have been tried to achieve postoperative pain relief following laparoscopic surgery. These include port site infiltration with LAs, intraperitoneal instillation of LAs, parenteral opioids, and nonsteroidal anti-inflammatory drugs (NSAIDs).,
Incision for operative ports is the most common cause for postoperative pain following laparoscopic surgery. Hence, preemptive port site infiltration with LA is an effective means of reducing postoperative pain following laparoscopic appendectomy. Port site infiltration has been found to be useful in reducing opioid requirement in the postoperative period following laparoscopic surgery., This modality of analgesia is cost effective, with least systemic side effects and convenient compared to other modalities.
Concept of preemptive analgesia is based on the hypothesis that the most effective way to eliminate or reduce postoperative pain is to prevent nociceptive input from afferent stimuli to the central nervous system (CNS), hence preventing CNS hyperexcitability.
Liu et al. studied the effect of port site infiltration with LAs (ropivacaine vs. placebo) on postoperative pain following laparoscopic cholecystectomy. They used 6 mL of LA at umbilical port and epigastric port and 4 mL at each working port. The study concluded that port site infiltration with LA is an effective method of reducing postoperative pain. Several other studies have also used the same amount of LA for port site infiltration. Hence, in our study, we have used 6 mL and 4 mL of LA at umbilical and working port, respectively.
In our study, the mean VAS score was <3 and was comparable (P > 0.05) at all the recorded time intervals in both the groups. Hence, both levobupivacaine and ropivacaine were found to be equally effective in providing postoperative analgesia following laparoscopic appendicectomy.
Out of thirty patients in each group, five patients in Group 1 and six patients in Group 2 recorded VAS score >3 and required rescue analgesia. Maximum VAS score recorded in Group 1 was 6 and in Group 2 was also 6. When compared statistically, the difference was not found to be significant (P = 0.843). The maximum VAS score was recorded at 0 h in both Group 1 and Group 2. All patients who required rescue analgesia required it at 0 h, i.e., immediate postoperative. However, in these patients, the second dose of rescue analgesia was not required. Hence, in our study, preemptive port site infiltration with both levobupivacaine and ropivacaine was found to be effective in preventing postoperative pain following laparoscopic appendicectomy. Between the two drugs, there was no distinct advantage of either.
In a study, Cervini et al. studied the effect of preemptive infiltration with 0.5% bupivacaine on parenteral narcotic requirement in the postoperative period following laparoscopic appendicectomy. They concluded that preemptive infiltration with bupivacaine decreased the need for postoperative parenteral narcotics following laparoscopic appendicectomy.
Ingelmo et al. found that in children receiving one minimum alveolar anesthetic concentration of sevoflurane, there were no significant differences in the ED50 for caudal levobupivacaine and ropivacaine. They concluded by saying that that caudal levobupivacaine and ropivacaine have a similar potency. Hence, we compared 0.5% levobupivacaine and 0.5% ropivacaine which have been found to be equipotent. Ropivacaine 0.5% showed similar characteristics as levobupivacaine 0.5% when used in axillary, interscalene, sciatic, or combined femoral and sciatic nerve block.,,,,
In another study done by Goldstein et al., for prevention of postoperative pain in patients undergoing laparoscopic gynecologic surgeries, a total of 180 patients were randomly assigned into three groups to receive an intraperitoneal instillation of 20 mL of either bupivacaine 0.5% (Group B), ropivacaine 0.75% (Group R), or saline (Group S) at the end of surgery. The morphine consumption in Group R was significantly less than in Group B and Group S. Ropivacaine 0.5% showed similar characteristics as levobupivacaine 0.5% when used in axillary, interscalene, sciatic, or combined femoral and sciatic nerve block.,,
With the expanding role of ambulatory and minimally invasive surgery, the need to facilitate an earlier discharge improving postoperative discomfort related to pain due to surgery and repeated intramuscular/IV analgesia has become an increasingly important issue. The present study showed that single time preincisional port site infiltration with both 0.5% levobupivacaine and 0.5% ropivacaine in patients undergoing laparoscopic appendectomy is equally effective in terms of postoperative pain relief and decreases the need of analgesics such as opioids or NSAIDs with minimal discomfort and adverse effects. Thus reduces need for hospital stay just for analgesia postoperatively while the patient resumes daily routine activities early. However, large multicentric studies are required to confirm these findings. Further research with lower concentrations of LAs can be undertaken to decrease the dose of LA used.
| Conclusion|| |
Preincisional port site infiltration with both 0.5% levobupivacaine and 0.5% ropivacaine is equally effective in providing postoperative pain relief in patients undergoing elective laparoscopic appendectomy.
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Conflicts of interest
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| References|| |
Downs SH, Black NA, Devlin HB, Royston CM, Russell RC. Systematic review of the effectiveness and safety of laparoscopic cholecystectomy. Ann R Coll Surg Engl 1996;78:241-323.
McMahon AJ, Russell IT, Ramsay G, Sunderland G, Baxter JN, Anderson JR, et al
. Laparoscopic and minilaparotomy cholecystectomy: A randomized trial comparing postoperative pain and pulmonary function. Surgery 1994;115:533-9.
Squirrell DM, Majeed AW, Troy G, Peacock JE, Nicholl JP, Johnson AG. A randomized, prospective, blinded comparison of postoperative pain, metabolic response, and perceived health after laparoscopic and small incision cholecystectomy. Surgery 1998;123:485-95.
Fornari M, Miglietta C, Di Gioia S, Garrone C, Morino M. The use of intraoperative topical bupivacaine in the control of postoperative pain following laparoscopic cholecystectomy. Minerva Chir 1996;51:881-5.
Ure BM, Troidl H, Spangenberger W, Neugebauer E, Lefering R, Ullmann K, et al
. Preincisional local anesthesia with bupivacaine and pain after laparoscopic cholecystectomy. A double-blind randomized clinical trial. Surg Endosc 1993;7:482-8.
Liu YY, Yeh CN, Lee HL, Wang SY, Tsai CY, Lin CC, et al
. Local anesthesia with ropivacaine for patients undergoing laparoscopic cholecystectomy. World J Gastroenterol 2009;15:2376-80.
Whiteside JB, Wildsmith JA. Developments in local anaesthetic drugs. Br J Anaesth 2001;87:27-35.
McClure JH. Ropivacaine. Br J Anaesth 1996;76:300-7.
Kuthiala G, Chaudhary G. Ropivacaine: A review of its pharmacology and clinical use. Indian J Anaesth 2011;55:104-10.
] [Full text]
Birnbaum BA, Wilson SR. Appendicitis at the millennium. Radiology 2000;215:349-52.
Møiniche S, Mikkelsen S, Wetterslev J, Dahl JB. A qualitative systematic review of incisional local anaesthesia for postoperative pain relief after abdominal operations. Br J Anaesth 1998;81:377-83.
Memdov C, Mentes O, Simsek A, Kece C, Yagci G, Harlak A. Comparison of analgesic effects of intraperitoneal lornoxicam and ropivacaine administration in laparoscopic cholecystectomy. Balkan Med J 2010;27:142-9.
Ahn SR, Kang DB, Lee C, Park WC, Lee JK. Postoperative pain relief using wound infiltration with 0.5% bupivacaine in single-incision laparoscopic surgery for an appendectomy. Ann Coloproctol 2013;29:238-42.
Cantore F, Boni L, Di Giuseppe M, Giavarini L, Rovera F, Dionigi G. Pre-incision local infiltration with levobupivacaine reduces pain and analgesic consumption after laparoscopic cholecystectomy: A new device for day-case procedure. Int J Surg 2008;6 Suppl 1:S89-92.
Kehlet H, Gray AW, Bonnet F, Camu F, Fischer HB, McCloy RF, et al
. Aprocedure-specific systematic review and consensus recommendations for postoperative analgesia following laparoscopic cholecystectomy. Surg Endosc 2005;19:1396-415.
Morsy KM, Mohamad Abdalla EE. Postoperative pain relief after laparoscopic cholecystectomy: Intraperitoneal lidocaine versus nalbuphine. Ain Shams J Anaesthesiol 2014;7:40-4.
Cervini P, Smith LC, Urbach DR. The effect of intraoperative bupivacaine administration on parenteral narcotic use after laparoscopic appendectomy. Surg Endosc 2002;16:1579-82.
Ingelmo P, Frawley G, Astuto M, Duffy C, Donath S, Disma N, et al
. Relative analgesic potencies of levobupivacaine and ropivacaine for caudal anesthesia in children. Anesth Analg 2009;108:805-13.
Bicer C, Eskitascioglu T, Aksu R, Ulgey A, Yildiz K, Madenoglu H. Comparison of preincisional infiltrated levobupivacaine and ropivacaine for acute postoperative pain relief after septorhinoplasty. Curr Ther Res Clin Exp 2011;72:13-22.
Goldstein A, Grimault P, Henique A, Keller M, Fortin A, Darai E. Preventing postoperative pain by local anesthetic instillation after laparoscopic gynecologic surgery: A placebo-controlled comparison of bupivacaine and ropivacaine. Acta Anesth Scand 2008;41:193-8.
Bajwa SJ, Kaur J. Clinical profile of levobupivacaine in regional anesthesia: A systematic review. J Anaesthesiol Clin Pharmacol 2013;29:530-9.
] [Full text]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]