|Year : 2019 | Volume
| Issue : 1 | Page : 16-19
Use of combined wound and intraperitoneal ropivacaine instillation in laparoscopic cholecystectomy for postoperative pain management: A prospective randomized study at a referral center in Northeast India
Mohan Kant Thakur1, Kshetrimayum Raju Singh2, Laishram Jaleshwar Singh3, Chongtham Arun Kumar Singh4
1 Senior Resident, Deen Dayal Upadyay Hospital, Delhi, India
2 Associate Professor, Regional Institute of Medical Sciences, Imphal, Manipur, India
3 Assistant Professor, Regional Institute of Medical Sciences, Imphal, Manipur, India
4 Professor, Regional Institute of Medical Sciences, Imphal, Manipur, India
|Date of Web Publication||14-Oct-2019|
Mohan Kant Thakur
Deen Dayal Upadyay Hospital, Delhi
Source of Support: None, Conflict of Interest: None
Background: Although laparoscopic cholecystectomy(LC) causes less postoperative pain than conventional laparotomy, still patients often suffer from considerable pain during early postoperative hours. In this study, efficacy of ropivacaine was studied in post-operative pain relief through peripheral local administration in patients undergoing LC.
Aims and Objectives: The primary aim of the study is to evaluate the effect of intraperitoneal and local wound instillation of 0.75% Ropivacaine on post operative pain relief and duration of post-operative hospital stay in LC patients.
Materials and Methods: This Prospective randomized Double blind clinical study was performed for 2 years on 190 patients. The primary endpoints of the study for the postoperative pain assessment were Visual Analog Scale (VAS) scores at 6 and 24 hours after LC and the amount of analgesics required in the postoperative period. These variables were compared between intervention and control groups.
Results: The VAS score for pain abdomen in the intervention group (ropivacaine group) was significantly less, compared to the placebo group at 6 (P < 0.020) and 24 h (P < 0.001). Similarly, the mean of amount of analgesics used was much less in intervention group (46.5±13.2) than that in the placebo group (112.4±26.4).
Conclusion: This study concludes that the combined intraperitoneal and local wound instillation of ropivacaine has a significant effect on the postoperative pain management in LC.
Keywords: Laparoscopic cholecystectomy, local anesthetic, postoperative pain
|How to cite this article:|
Thakur MK, Singh KR, Singh LJ, Kumar Singh CA. Use of combined wound and intraperitoneal ropivacaine instillation in laparoscopic cholecystectomy for postoperative pain management: A prospective randomized study at a referral center in Northeast India. J Med Soc 2019;33:16-9
|How to cite this URL:|
Thakur MK, Singh KR, Singh LJ, Kumar Singh CA. Use of combined wound and intraperitoneal ropivacaine instillation in laparoscopic cholecystectomy for postoperative pain management: A prospective randomized study at a referral center in Northeast India. J Med Soc [serial online] 2019 [cited 2019 Dec 14];33:16-9. Available from: http://www.jmedsoc.org/text.asp?2019/33/1/16/269114
| Introduction|| |
In 1987, the first laparoscopic cholecystectomy (LC) was performed by Philippe Mouret in France. Over the last several years, this minimally invasive procedure has emerged worldwide as the preferred treatment of choice for patients with uncomplicated cholelithiasis and cholecystitis. Benefits in comparison to conventional laparotomy are shorter lived effects on pulmonary function, less postoperative pain, earlier recovery of peristalsis, short hospital stay, faster postoperative recovery, and minimal scar. However, patients often suffer from considerable pain during the first 24 postoperative hours.
Pain after laparoscopic surgery has three components, namely, visceral pain from stretching of intra-abdominal cavity and peritoneal inflammation, shoulder pain from phrenic nerve irritation caused by residual CO2 in the peritoneal cavity, and peritoneal pain due to surgical incision which is much less in intensity by virtue of its small size. Opioids and nonsteroidal anti-inflammatory drugs are generally used for the management of postoperative pain after LC.
Studies have shown that infiltrating local anesthesia after surgery, through the port site and intraperitoneally, reduced the intensity of pain, the number of patients requiring postoperative analgesia, the number of doses required, and hence the duration of hospital stay.
A number of local anesthetics (LAs) have been used in practice, namely lignocaine, bupivacaine, and the latest being ropivacaine. The reason for preferring ropivacaine in our study is that it is a long-acting agent (6–12 h) and lesser cardiotoxic than bupivacaine.
Postoperative somatovisceral and port-site pain after LC remains one of the hurdles to overcome in a procedure that otherwise helps to considerably decrease the patient's discomfort and hospital stay. Thus, any method to decrease the postoperative pain would add to the already multiple advantages of LC. Hence, we undertook this study to evaluate the efficacy of ropivacaine in postoperative pain relief through peripheral local administration in patients undergoing LC.
| Patients and Methods|| |
We studied a total of 190 patients who underwent elective LC over a span of 2 years. The study was approved by the institutional ethics committee, and informed consent was taken from all the participants. All the participants were subjected to similar processes of clinical evaluation and laboratory and imaging studies. Patients were randomly allotted to two groups, with one receiving port-site infiltration of LA and an intraperitoneal LA diluted with 0.9% normal saline (NS) and the other receiving placebo control through a port site and an intraperitoneal instillation of 0.9% NS.
For intraperitoneal instillation, 5 mg/kg of 0.75% ropivacaine in 200 ml of 0.9% NS was used within the operative field. The first 100 ml of the infusion was administered in the right subdiaphragmatic region and the second 100 ml in the left subdiaphragmatic region. All infusion fluids were drained out after completion of the LC. For local port-site infiltration, 20 ml of 0.75% ropivacaine was instilled just before the wound closure under direct vision, i.e., 6 ml at the epigastric port, 6 ml at the umbilical port, and 4 ml at each working port. In the placebo control group, 200 ml of only 0.9% NS was used in the operative field for intraperitoneal instillation and 20 ml of 0.9% NS was instilled under direct vision, as in the intervention group. Prior sensitivity test for ropivacaine was done by intradermal injection of 0.75% ropivacaine in patients of both the groups.
A 10-cm vertical Visual Analog Scale (VAS) ranging from no pain to worst possible pain was used to assess the postoperative pain at 6 h after surgery and at 24 h after surgery. The pain score recorded by the resident blinded to the patient groups is defined as the VAS score. Outcome was measured in terms of operative time, operative outcomes, VAS scores at 6 h and 24 h after surgery, amount of analgesics required postoperatively, and the days of hospital stay. Diclofenac was used for pain relief in the postoperative period, and tramadol was further used as rescue pain relief if diclofenac does not work well.
| Results|| |
The two groups were comparable in relation to age, gender (majority were females in both groups), religion, residence (urban or rural), body weight, body mass index, and presence of hypertension and diabetes. There was 5-min difference in the timing of operation, but it was found to be statistically insignificant (P > 0.05). Mean VAS of the intervention group was lower than mean VAS of the placebo group. In the intervention group, no-distress patients (22.1%) were more than that of the placebo group (6.3%) and also for the other VAS groups [Table 1]. This finding was found to be statistically significant (P < 0.05). At 24 h, there was more improvement in VAS in the intervention group than the placebo group, which was statistically significant [Table 2]. Use of analgesic was also drastically reduced in the intervention group (46.5 ± 13.2 mg) than that of the placebo group (46.5 ± 13.2 mg) (P < 0.05) [Table 3]. The intervention group stayed for 2.3 days (approx. 2 days) and the placebo group stayed for around 3 days in the hospital after operation, and this finding was found to be statistically significant (P < 0.05).
|Table 1: Distribution of respondents by Visual Analog Scale score at 6 h|
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|Table 2: Distribution of respondents by Visual Analog Scale score at 24 h|
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| Discussion|| |
This prospective randomized double-blind clinical study was conducted in the Department of Surgery, Regional Institute of Medical Sciences, Imphal, Manipur, for 2 years among 190 patients (95 in each group) undergoing elective LC to evaluate and compare the postoperative pain relief in LC patients using intraperitoneal and local wound instillation of 0.75% ropivacaine than those receiving none.
Ropivacaine is a long-acting LA that was developed after the emergence of bupivacaine-related severe toxicity. It is a pure left isomer and has less toxic potential on the central nervous system and the circulatory system. Although the peak concentration of ropivacaine (0.75%, 300 mg) was 3.01–4.32 μg/ml when injected intraperitoneally immediately after pneumoperitoneum and at the end of the surgery, it did not induce any clinical evidence of toxicity. The large dose of ropivacaine (300 mg) not only produced similar analgesia (when compared with 100 mg), but also led to large plasma concentrations. Considering the patients' safety, the maximum dosage of ropivacaine used in the present trial was 200 mg, which is a safe dose for infiltration anesthesia in an adult patient.
Intraperitoneal 5 mg/kg of 1.0% levoropivacaine in 200 ml of NS ahead of the surgery plus incisional 20 ml of 1.0% levoropivacaine at four port sites immediately after wound closure decreased the immediate postoperative pain and the duration of hospital stay in a study by Yeh et al. However, it is not a randomized double-blinded trial unlike our study.
In this study, VAS score was used to compare the postoperative pain; at 6 h, VAS score of 0–1 (no distress) was more in the intervention group (22.1%) than that of placebo group (6.3%) [Table 1]. More severe pain at 6 h was observed in the placebo-controlled group in this study. At 24 h, the number of patients with no distress increased up to 43.2% in the intervention group than up to 18.9% in the placebo-controlled group [Table 2]. Simply, this study demonstrates that the combination of intraperitoneal instillation and local wound instillation of 0.75% ropivacaine reduces abdominal pain significantly after LC. The VAS score for pain abdomen in the intervention group (ropivacaine group) was significantly less, compared to the placebo group at the 6th (P < 0.020) and 24th h (P < 0.001) [Figure 1] and [Figure 2]. These findings are in concordance with those of Labaille et al.
|Figure 1: Distribution of respondents by Visual Analog Scale score at 6 h|
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|Figure 2: Distribution of respondents by Visual Analog Scale score at 24 h|
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This study finding is also in concordance with various authors like Gupta et al., Trikoupi et al., Kucuk et al., Memedov et al., Pavlidis et al., and Park et al., who have found that the intraperitoneal instillation of local anesthesia decreases the visceral pain after laparoscopic surgery. Hence, our study demonstrates that intraperitoneal instillation of ropivacaine reduces the incidence and intensity of upper abdominal pain after LC.
| Conclusion|| |
In this study, mean VAS score at 6 h was significantly reduced in the intervention group. The number of patients with no distress was also high among the intervention group at 6 h, although findings were similar at 24 h. Moreover, amount of analgesic used also drastically reduced in the intervention group. Thus the intervention group was better than the study group in allaspects.
Thus, to conclude, combined intraperitoneal and local wound instillation of ropivacaine has a significant effect on the postoperative pain management in LC.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]