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临床试验/NCT07253610
NCT07253610已完成不适用

Investigation of the Effects of Bilateral Rectointercostal Fascial Plane Block on Postoperative Acute Pain in Patients Undergoing Laparoscopic Sleeve Gastrectomy

Samsun University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
Cumulative Opioid Consumption in the First 24 Hours After Surgery

研究概览

简要总结

This randomized controlled study aims to evaluate the effectiveness of the bilateral rectointercostal fascial plane (RIB) block for postoperative pain management in patients undergoing laparoscopic sleeve gastrectomy. The study compares RIB block combined with standard general anesthesia to standard intravenous patient-controlled analgesia alone. The primary outcome is total opioid consumption within the first 24 postoperative hours, while secondary outcomes include pain scores, patient satisfaction, postoperative nausea and vomiting, and block-related complications.

详细描述

Adequate pain relief in the postoperative period is a crucial determinant of patient comfort, early mobilization, and overall recovery after laparoscopic sleeve gastrectomy. Effective analgesia not only enhances patient satisfaction but also reduces postoperative complications, facilitates respiratory function, and shortens hospital stay. Conversely, inadequate pain control may lead to delayed mobilization, nausea, vomiting, increased opioid requirements, and prolonged recovery.

In recent years, regional anesthesia techniques, particularly abdominal wall and fascial plane blocks, have become an integral part of multimodal analgesia strategies designed to reduce opioid consumption and minimize related adverse effects. The rectointercostal fascial plane (RIB) block, first described by Tulgar et al. in 2023, is a novel regional technique that targets the thoracoabdominal intercostal nerves by injecting local anesthetic between the rectus abdominis and intercostal muscles at the level of the costal cartilage. This block has shown promising results in providing effective postoperative analgesia after upper abdominal laparoscopic surgeries.

The present randomized controlled study was designed to evaluate the effectiveness of the bilateral rectointercostal fascial plane block compared with standard intravenous patient-controlled analgesia in patients undergoing laparoscopic sleeve gastrectomy. The primary outcome is total opioid consumption during the first 24 postoperative hours, and the secondary outcomes include pain scores at rest and during movement, patient satisfaction, incidence of postoperative nausea and vomiting, and block-related complications.

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
Double (Participant, Outcomes Assessor)

盲法说明

Double-blind design: Participants and the outcomes assessor were blinded to group allocation. The anesthesiologist performing the block was not blinded due to the nature of the intervention.

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age between 18 and 65 years
  • •Body mass index (BMI) > 35 kg/m²
  • •American Society of Anesthesiologists (ASA) physical status II-III
  • •Scheduled for elective laparoscopic sleeve gastrectomy under general anesthesia
  • •Provided written informed consent to participate in the study

排除标准

  • •Chronic opioid use or dependence
  • •History of chronic pain
  • •Known allergy or contraindication to local anesthetics or opioids
  • •Severe cardiac, hepatic, or renal disease
  • •Severe psychiatric disorder (e.g., psychosis, dementia)
  • •STOP-BANG score ≥ 5 (high risk for obstructive sleep apnea)
  • •Block failure or incomplete block after local anesthetic injection

研究组 & 干预措施

Bilateral Rectointercostal Fascial Plane Block Group

Experimental

Participants in this group will receive bilateral rectointercostal fascial plane (RIB) block under ultrasound guidance prior to induction of general anesthesia. Following surgery, standard intravenous patient-controlled analgesia (PCA) with morphine will be administered.

干预措施: Bilateral Rectointercostal Fascial Plane Block (Other)

Bilateral Rectointercostal Fascial Plane Block Group

Experimental

Participants in this group will receive bilateral rectointercostal fascial plane (RIB) block under ultrasound guidance prior to induction of general anesthesia. Following surgery, standard intravenous patient-controlled analgesia (PCA) with morphine will be administered.

干预措施: Intravenous Patient-Controlled Analgesia (IV PCA) with Morphine (Other)

Control Group (General Anesthesia + PCA)

Active Comparator

Participants in this group will receive only general anesthesia followed by standard intravenous patient-controlled analgesia (PCA) with morphine. No fascial plane block will be performed.

干预措施: Intravenous Patient-Controlled Analgesia (IV PCA) with Morphine (Other)

结局指标

主要结局

Cumulative Opioid Consumption in the First 24 Hours After Surgery

时间窗: Postoperative day 1 (0-24 hours after surgery)

The primary outcome is defined as the total cumulative opioid consumption during the first 24 hours after surgery. Opioid use will be recorded as the total amount of morphine administered via intravenous patient-controlled analgesia (PCA). Patients will be instructed to request analgesia through the PCA device whenever their numeric rating scale (NRS) pain score is ≥4. No basal infusion will be used

次要结局

未报告次要终点

研究者

发起方
Samsun University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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