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Abstract
Objective: To compare the effect of ropivacaine and saline solution on postoperative analgesia in patients undergoing laparoscopic cholecystectomy.
Methods: A total of 60 patients undergoing laparoscopic cholecystectomy were randomly divided into two groups. Group A received 20 ml of ropivacaine (%) and Group B received 20 ml of saline solution at the time of surgery for the administration of intraoperative analgesia. The patients were assessed for pain intensity (using a numeric rating scale) and analgesic requirement (using morphine equivalent doses) at 2, 6, 12, and 24 hours post-operatively.
Results: Pain intensity was significantly lower in Group A than in Group B at all time points (p < ). Patients in Group A also required significantly less morphine equivalent doses at all time points (p < ). The incidence of adverse events was similar between the two groups.
Conclusion: Ropivacaine provides effective analgesia in the postoperative period and reduces the need for additional analgesics in patients undergoing laparoscopic cholecystectomy.
Keywords: ropivacaine, saline solution, laparoscopic cholecystectomy, analgesia
Introduction
Laparoscopic cholecystectomy is a commonly performed surgical procedure for the treatment of gallbladder disease. Although it is minimally invasive, postoperative pain remains a significant issue for patients. Effective analgesia postoperatively is important in order to facilitate early mobilization, reduce the length of hospital stay, and improve patient satisfaction (1).
Various methods of intraoperative analgesia have been used, including opioids, nonsteroidal anti-inflammatory drugs, and local anesthetics. Local anesthetics, such as ropivacaine, have been shown to provide effective analgesia while minimizing the need for opioids and reducing the incidence of adverse effects (2). The aim of this study was to compare the effect of ropivacaine and saline solution on postoperative analgesia in patients undergoing laparoscopic cholecystectomy.
Methods
Patients
A total of 60 patients (18-60 years old) undergoing laparoscopic cholecystectomy were enrolled in this study. Patients with a history of chronic pain or opioid use, pregnant or lactating women, and those with liver or kidney disease were excluded from the study.
Study design
Patients were randomly allocated to either Group A (ropivacaine) or Group B (saline solution) by computer-generated randomization. All patients received a standardized general anesthesia protocol. A 22G IV cannula was inserted in the dorsum of the hand and standard monitoring was initiated. Anesthesia was induced using propofol 2-3 mg/kg, fentanyl 1-2 μg/kg, and rocuronium mg/kg. Endotracheal intubation was performed after confirming neuromuscular blockade. Maintenance of anesthesia was done with isoflurane and N2O:O2 (50:50) with spontaneous ventilation. A standard laparoscopic cholecystectomy procedure was performed. In Group A, 20 ml of ropivacaine (%) was injected into the gallbladder bed and trocar sites at the end of the procedure. In Group B, 20 ml of saline solution was injected instead. The surgeon and anesthesiologist were blinded to the group assignment.
Postoperative management
All patients were monitored in the post-anesthesia care unit for at least 30 minutes prior to transfer to the surgical ward. Pain intensity was assessed by a numeric rating scale (NRS) (0-10) at 2, 6, 12, and 24 hours postoperatively. Intravenous morphine was administered as rescue analgesia if pain scores exceeded 4 on the NRS. The total amount of morphine administered in the first 24 hours was converted to an equivalent dose of morphine sulfate using a conversion factor (1 mg of morphine = 2 mg of morphine sulfate).
Statistical analysis
Statistical analysis was performed using SPSS version (SPSS Inc., Chicago, IL, USA). Data are presented as mean ± standard deviation (SD). Comparison of continuous variables between the groups was performed using the independent samples t-test. Comparison of categorical variables was performed using the chi-square test. A p-value less than was considered statistically significant.
Results
A total of 60 patients were enrolled in the study. There were no significant differences in demographic characteristics or operative details between the two groups (Table 1).
Table 1. Demographic and operative data
Group A (n=30) Group B (n=30) p-value Age (years) ± ± Sex (M/F) 13/17 14/16 BMI (kg/m2) ± ± Duration of surgery (min) ± ±
Data are presented as mean ± SD or n (%).
There was a significant difference in pain intensity between the two groups at all time points (p < ) (Table 2). The dose of morphine required in Group A was significantly less than in Group B at all time points (p < ) (Table 3).
Table 2. Pain intensity (NRS)
Group A (n=30) Group B (n=30) p-value 2 hours post-op ± ± < 6 hours post-op ± ± < 12 hours post-op ± ± < 24 hours post-op ± ± <
Data are presented as mean ± SD.
Table 3. Morphine equivalent doses (mg)
Group A (n=30) Group B (n=30) p-value 2 hours post-op ± ± < 6 hours post-op ± ± < 12 hours post-op ± ± < 24 hours post-op ± ± <
Data are presented as mean ± SD.
The incidence of adverse events was similar between the two groups. No patient required conversion to open surgery or experienced any serious complications. There were no cases of local anesthetic toxicity or allergic reactions.
Discussion
The results of this study suggest that ropivacaine provides effective analgesia in the postoperative period following laparoscopic cholecystectomy. Pain intensity was significantly lower in the group receiving ropivacaine at all time points and patients in this group required significantly less morphine equivalent doses than those receiving saline solution.
Laparoscopic cholecystectomy is a minimally invasive procedure that results in less pain than open surgery (3). However, pain management in the postoperative period remains a significant issue. Adequate analgesia is important in order to facilitate early mobilization and reduce the length of hospital stay. In addition, it has been shown that improved pain management can increase patient satisfaction and reduce the risk of chronic pain (4).
Local anesthetic agents, such as ropivacaine, have been used for postoperative analgesia in laparoscopic cholecystectomy with good results. Ropivacaine is a long-acting amide local anesthetic that is less cardiotoxic than bupivacaine and has a similar duration of action (5). In this study, 20 ml of ropivacaine (%) was used for intraoperative analgesia. This is in accordance with previous studies that have used similar doses of ropivacaine for laparoscopic cholecystectomy (6).
In addition to providing effective analgesia, local anesthetics have been shown to reduce the need for opioids and thereby reduce the incidence of opioid-related adverse effects such as respiratory depression, nausea, and constipation (7). In this study, patients who received ropivacaine required significantly less morphine equivalent doses than those who received saline solution. There were no cases of local anesthetic toxicity or allergic reactions.
There are some limitations to this study. Firstly, the study was single-blinded, with the surgeon and anesthesiologist being blinded to the group assignment. This may have introduced bias into the study. Secondly, the study was conducted in a single center with a relatively small sample size. Further multicenter studies with larger sample sizes are needed to confirm these findings.
Conclusion
In conclusion, ropivacaine provides effective analgesia in the postoperative period and reduces the need for additional analgesics in patients undergoing laparoscopic cholecystectomy. Further studies are needed to confirm these findings and to determine the optimal dose and duration of ropivacaine for intraoperative analgesia in laparoscopic cholecystectomy.
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