A Comparative Study to Assess Pain Control and Post-Operative Analgesic Consumption With or Without the Infiltration of Bupivacaine at Port Sites in Patients Undergoing Elective Laparoscopic Cholecystectomy at a Tertiary Care Hospital
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
研究概览
简要总结
Laparoscopic cholecystectomy (LC) has revolutionized the treatment of gallbladder diseases, offering advantages such as reduced postoperative pain, shorter hospital stays, and faster recovery compared to traditional open cholecystectomy. However, despite these advantages, postoperative pain remains a significant challenge, particularly at the port sites and due to intra-abdominal insufflation. The management of postoperative pain is crucial, as inadequate pain control can lead to delayed recovery, increased length of stay, and patient dissatisfaction. Therefore, effective analgesic strategies are integral to optimizing outcomes in patients undergoing laparoscopic surgery.
Pain after laparoscopic surgery is typically classified as somatic pain, originating from the abdominal wall at the port sites, and visceral pain, resulting from the distension of the peritoneum due to insufflation. While systemic analgesics such as opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used to manage this pain, their adverse effects—such as sedation, nausea, vomiting, and delayed gastrointestinal recovery—often limit their effectiveness. Opioid-induced side effects, in particular, remain a concern, as these drugs are known to impair the patient’s ability to return to normal activities, including early mobilization, and increase the risk of postoperative complications.
To mitigate the need for systemic analgesics, regional techniques, including the local infiltration of anesthetics at port sites, have gained attention as promising alternatives. Local anesthetics such as bupivacaine have been increasingly used for their prolonged analgesic effects at the surgical site. Bupivacaine, a long-acting amide local anesthetic, provides superior analgesia by inhibiting nerve conduction through sodium channel blockade, thereby offering prolonged pain relief without systemic side effects. Local infiltration of bupivacaine at the port sites has been shown to reduce postoperative pain, minimize the consumption of analgesics, and improve patient comfort postoperatively, suggesting that it may serve as a valuable adjunct to multimodal pain management strategies in laparoscopic procedures.
Although numerous studies have explored the benefits of local anesthesia in laparoscopic surgery, the literature lacks conclusive evidence regarding the efficacy of bupivacaine infiltration at port sites specifically in the context of laparoscopic cholecystectomy. Many studies have shown that local anesthetic infiltration at incision sites results in reduced pain scores and lower opioid consumption. However, variation in methodology, such as differences in anesthetic doses, surgical technique, and postoperative care protocols, has led to inconsistent findings. Furthermore, limited studies have focused on the long-term impact of local anesthetics on patient satisfaction and overall recovery, which remain important factors for improving clinical outcomes.
This study aims to address this gap by evaluating the effects of bupivacaine infiltration at the port sites on postoperative pain levels, analgesic consumption, and overall patient recovery in patients undergoing elective laparoscopic cholecystectomy. By comparing two groups—one receiving local bupivacaine infiltration and the other receiving standard analgesic treatment without infiltration—this research will provide valuable insights into the role of local anesthetics in minimizing postoperative pain and enhancing recovery.
Given that laparoscopic cholecystectomy is one of the most frequently performed elective surgeries worldwide, the findings of this study have the potential to refine pain management strategies and contribute to improved patient care. By providing evidence-based recommendations, this research could help establish a more effective and patient-friendly approach to postoperative pain management, minimizing opioid use, enhancing recovery, and reducing the risk of adverse effects. Furthermore, the outcomes of this study may influence clinical practice guidelines and pain management protocols in hospitals and tertiary care centers globally, advancing the quality of care provided to surgical patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients aged 18 to 65 years.
- •Patients with a preoperative diagnosis of symptomatic cholelithiasis or chronic cholecystitis.
- •Patients scheduled for elective laparoscopic cholecystectomy.
- •Patients willing to provide written informed consent.
- •Patients classified as ASA Grade I or II (American Society of Anesthesiologists Physical Status Classification)
- •Both genders will be included in the study.
排除标准
- •Patients undergoing emergency cholecystectomy (e.g., acute cholecystitis, gallbladder perforation, gallstone ileus, emphysematous cholecystitis).
- •Patients with known allergy or hypersensitivity to Bupivacaine or amide-type local anesthetics.
- •Patients requiring conversion to open cholecystectomy during surgery.
- •Patients with coagulopathy or on anticoagulant/antiplatelet therapy (unless stopped appropriately pre-operatively).
- •Patients with severe hepatic, renal, or cardiac disease (e.g., ASA Grade III and above).
研究者
Dr B R SOYAL
Shimoga institute of medical sciences
