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临床试验/NCT07650760
NCT07650760招募中4 期

Comparison of Intraperitoneal Bupivacaine and Normal Saline Irrigation for Postoperative Pain Relief After Laparoscopic Cholecystectomy

Wah Medical college , POF hospital1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2026年7月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
106
试验地点
1
主要终点
Post operative pain relief

研究概览

简要总结

This randomized clinical trial compared intraperitoneal irrigation of bupivacaine(a local anesthetic) vs a control group receiving normal saline for relief of post operative pain following laparoscopic gallbladder surgery. A total of 106 patients divided into two equal groups, with one group receiving bupivacaine and the other treated using normal saline(control).Previous studies on the subject found that bupivacaine significantly reduced postoperative pain. Although conventional intravenous analgesics remain widely used, bupivacaine may be a better option, especially in difficult surgical cases.

详细描述

This randomized clinical trial was conducted to compare the effectiveness of intraperitoneal bupivacaine and normal saline for relief of post operative pain following laparoscopic cholecystectomy. A total of 106 patients undergoing elective laparoscopic gallbladder surgery were enrolled and randomly assigned into two equal groups. Non-probability consecutive sampling technique will be used to recruit patients.Patients with clinical findings of choledocholithiasis/pancreatitis/cholecystitis, who need intraoperative conversion to an open procedure, are pregnant or lactating, do not have the capacity to express pain, or have any contraindication to the drugs under study, will be excluded.In Group A, the patients received intraperitoneal irrigation of bupivacaine , while in Group B, only normal saline was used. The standard procedure of laparoscopic cholecystectomy will be similar in both groups, except for the difference that group A patients will undergo intraperitoneal instillation of 500ml normal saline solution, whereas those allocated into group B will have peritoneal irrigation using 20ml of 10% bupivacaine solution diluted in 480ml of normal saline to make a 500ml irrigation solution at the time of peritoneal closure. To ensure double blinding, the primary surgeon and patient will be blinded to the type of solution used. The time of extubation will be noted, which will be used to determine the duration of analgesia. Patients will be followed up for VAS scores at time intervals of 1, 2, 4, 6, 12, and 24 hours postoperatively. When the patient complains of pain, intravenous tramadol of 37.5mg mixed with an antiemetic will be administered.To reduce confounding, all procedures are done by the same consultant surgeon; no additional postoperative analgesic advised, and a blinded surgeon will evaluate the patient for the pain scores at these intervals, with due recording of the dosages of rescue analgesics and duration of analgesia.Past literature has provided some insight into the efficacy of bupivacaine in reducing postoperative pain, but existing evidence is not enough to establish clinical practice guidelines. Our study has the rationale of strengthening the existing body of evidence by extending the research.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

This study was conducted as a double-blinded randomized controlled trial. In this design, the outcome assessor (observer) was blinded to the group allocation, while the operating surgeon was also not aware of the intervention being performed.Blinding was achieved by ensuring that the trained observer responsible for recording postoperative outcomes, including post operative pain, did not know whether bupivacaine or normal saline was used during the procedure. This helped to minimize observer bias in outcome measurement

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Adult consented patients of any gender aged 18 to 60 years Fit to undergo elective laparoscopic cholecystectomy

排除标准

  • • Patients who had developed choledocholithiasis or pancreatitis pre-operatively
  • Where conversion to open cholecystectomy is needed intraoperatively
  • Pregnant or lactating
  • Inability to express pain appropriately, like in psychiatric disorders
  • With any contraindication to the use of bupivacaine or normal saline, e.g., hypersensitivity

研究组 & 干预措施

Placebo : group B: saline

Placebo Comparator

Placebo : group B: saline Group B is the arm where patients have received only intraperitoneal normal saline .

干预措施: Saline (0.9% NaCl) (Drug)

Experimental : group A: bupivacaine

Experimental

Group A is the arm where patients have received intraperitoneal bupivacaine during laparoscopic gallbladder surgery, and their post operative pain is compared .

干预措施: Bupivacain (Drug)

结局指标

主要结局

Post operative pain relief

时间窗: From the completion of the procedure til one hour after surgery

The study primarily aimed to compare post operative pain relief following intraperitoneal irrigation of bupivacaine vs normal saline.

次要结局

未报告次要终点

研究者

发起方
Wah Medical college , POF hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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