Analgesic Efficacy of Serratus Intercostal Plane Block Versus Port Infiltration in Laparoscopic Cholecystectomy: Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- efectiveness of analgesia (SIPB versus IP)
研究概览
简要总结
Most patients undergoing laparoscopic cholecystectomy (LC) experience moderate to severe pain in the first 24 hours after surgery. Port infiltration is the usual analgesic method while serratus-intercostal plane blockade (SIPB) has shown its efficacy in open cholecystectomy pain control. The aim of the present study was to compare the efficacy of both techniques in pain control.
OBJECTIVE The prospective randomised study has the working hypothesis is based on evaluating whether serratus-intercostal block (modified BRILMA) is equal or superior to laparoscopic port infiltration (PI) in terms of quality of postoperative recovery and pain control.
Secondary objectives of the study will be to assess the absence of adverse effects.
MATERIAL AND METHODS the investigators present a low-intervention clinical trial. The sample will be composed of 128 patients divided into two groups according to the analgesic technique (serratus-intercostal and port infiltration), following a 1:1 randomisation, consecutively until the sample size is reached and fulfilling the following criteria: signature of informed consent, over 18 years of age, ASA I-III, undergoing laparoscopic cholecystectomy.
Intraoperatively, patients will receive standard monitoring and induction. Analgesia will consist of a multimodal strategy (8 mg dexamethasone, 1 g paracetamol and 50 mg dexketoprofen pre-incisionally, intraoperative fentanyl on demand and the corresponding regional technique).
In the postoperative period, the main variable to be evaluated in forms designed for this purpose will be the difference in pain assessed by means of an numeric rating scale (NRS scale) and the quality of recovery will be measured by means of the modified Postoperative Quality of Recovery Score (QoR-15 ) recovery scale (15 responses).
详细描述
Background
Postoperative pain remains a significant concern following laparoscopic cholecystectomy (LC), with most patients experiencing moderate to severe pain within the first 24 hours. Traditionally, port-site infiltration (PI) with local anesthetics is employed for analgesia. However, the serratus-intercostal plane block (SIPB), also known as the modified BRILMA block, has demonstrated efficacy in pain management for open cholecystectomy. Its role in LC remains to be clarified.
Objective
The primary objective of this prospective randomised study is to evaluate whether SIPB (modified BRILMA block) provides equivalent or superior postoperative analgesia and quality of recovery compared to port-site infiltration in patients undergoing LC.
Secondary objective: To assess the incidence of adverse effects related to each analgesic technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
both groups are masked about the receiving analgesia
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-II-III
- •laparoscopic cholecystectomy
排除标准
- •Alergy to used drugs
研究组 & 干预措施
port infiltration
patients receiving port infiltration as analgesia
干预措施: serratus intercostal plane block as analgesic technique (Procedure)
结局指标
主要结局
efectiveness of analgesia (SIPB versus IP)
时间窗: one year
The working hypothesis is based on evaluating whether serratus-intercostal block (modified BRILMA) is equal or superior to laparoscopic port infiltration (PI) in terms of quality of postoperative recovery (QoR15) and pain control (NRS) 0-10
次要结局
- side efects(one year)
- Postoperative recovery(One year)
- Postoperative pain control(One year)
研究者
María Teresa Fernandez
MD, principal investigator
Hospital del Rio Hortega