此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Rectus Sheath Block Versus Transversus Abdominis Plane Block for Analgesia in Laparoscopic Bariatric Surgery (RSB-TAPB)

2026年5月13日 更新者：Kittitorn Supphapipat, MD、Chiang Mai University

Comparison of Rectus Sheath Block and Transversus Abdominis Plane Block for Analgesia in Laparoscopic Bariatric Surgery: A Randomized Controlled Trial

This randomized controlled trial aims to compare the analgesic efficacy of rectus sheath block (RSB) and transversus abdominis plane block (TAPB) in patients undergoing laparoscopic bariatric surgery. Both techniques are regional anesthesia methods used as part of multimodal analgesia to reduce postoperative pain and opioid requirements.

Eligible participants will be randomly assigned to receive either a RSB or a TAPB after general anesthesia. Postoperative pain scores, opioid consumption, recovery outcomes, area of sensory loss, time to first rescue analgesia, and block-related adverse events will be assessed and compared between the two groups.

This study will help determine which regional anesthesia technique provides more effective postoperative analgesia for laparoscopic bariatric surgery

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Laparoscopic bariatric surgery provides sustained weight loss for patients with obesity and is associated with improved metabolic outcomes and increased life expectancy. Despite its minimally invasive approach, laparoscopic bariatric surgery is often associated with moderate-to-severe postoperative pain, which may require significant opioid use. Postoperative opioid administration may increase the risk of opioid-related adverse effects, including opioid-induced ventilatory depression and postoperative nausea and vomiting. These concerns are particularly important in patients with obesity, who may have an increased risk of obstructive sleep apnea and opioid-related respiratory complications.

Enhanced Recovery After Surgery principles recommend opioid-sparing strategies, including regional anesthesia and local anesthetic techniques, as part of multimodal analgesia for bariatric surgery. Several regional analgesic techniques have been used for laparoscopic bariatric surgery, including local infiltration analgesia, transversus abdominis plane block, rectus sheath block, and other fascial plane blocks.

Transversus abdominis plane block is commonly used for abdominal surgery and provides somatic analgesia to the anterolateral abdominal wall. However, its analgesic efficacy in laparoscopic bariatric surgery remains variable, partly due to differences in block technique, injection site, local anesthetic regimen, and technical challenges in patients with obesity. Excessive subcutaneous tissue may make identification of the target fascial plane more difficult and may increase the risk of inaccurate needle placement or incomplete sensory blockade.

Rectus sheath block is another regional anesthesia technique used for abdominal surgery. It involves the injection of local anesthetic between the rectus abdominis muscle and the posterior rectus sheath, providing analgesia to the anterior abdominal wall, particularly around the midline and periumbilical region. Rectus sheath block may be technically easier to perform than transversus abdominis plane block in patients with obesity because of its more superficial needle trajectory. Previous studies suggest that rectus sheath block may reduce postoperative pain and opioid consumption compared with systemic analgesia alone or local infiltration analgesia.

Although both rectus sheath block and transversus abdominis plane block may improve postoperative analgesia after laparoscopic bariatric surgery, their relative efficacy remains unclear. No previous study has directly compared these two techniques for postoperative analgesia in this surgical population.

This randomized controlled trial will compare the analgesic efficacy and opioid-sparing effects of ultrasound-guided rectus sheath block (RSB) and ultrasound-guided transversus abdominis plane block (TAPB) in patients undergoing laparoscopic bariatric surgery. Eligible participants will be randomly assigned to receive either RSB or TAPB as part of perioperative multimodal analgesia.

The study will assess postoperative pain intensity, opioid consumption, quality of recovery, rescue analgesic requirements, and block-related adverse events. The primary analysis will evaluate whether one technique provides superior analgesia. If superiority is not demonstrated, equivalence will be assessed. The findings may help guide the selection of regional anesthesia techniques for postoperative analgesia in patients undergoing laparoscopic bariatric surgery.

研究类型

介入性

注册 (估计的)

96

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 泰国
    • Mueang
      • Chiang Mai、Mueang、泰国、50200
        • Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University
        • 接触：
        • 接触：
        • 首席研究员：
          • Artid Samerchua, MD
        • 首席研究员：
          • Kittitorn Supphapipat, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Patients aged 20-60 years old
  • Scheduled for elective LBS including laparoscopic sleeve gastrectomy, proximal jejunal bypass, and Roux-en-Y gastric bypass
  • American Society of Anesthesia (ASA) physical status III
  • Have ability to communicate and understand the study and accept to participate in the study

Exclusion Criteria:

  • Patients who have following underlying disease: severe hepatic impairment [diagnosed of cirrhosis (Child-Pugh C)], coagulopathy (diagnosed of disease associated with abnormal coagulation), pre-existing neurological deficits, chronic pain (diagnosed of chronic pain disease or current use regular analgesic drugs), or any drug addiction.
  • Known allergy to bupivacaine or weighing less than 60 kg, as the planned doses of bupivacaine may exceed safe maximum limits.
  • Patient with previous foregut surgery including esophageal, gastric, liver and pancreases resection.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Rectus Sheath Block Group
Participants in this group will receive bilateral ultrasound-guided rectus sheath block using 30 mL of 0.25% bupivacaine with epinephrine 5 µg/mL on each side, in addition to standard perioperative multimodal analgesia.
程序：Rectus Sheath Block
Bilateral rectus sheath block will be performed by an anesthesiologist experienced in ultrasound-guided regional anesthesia. The ultrasound probe will be positioned at the midpoint between the xiphoid process and the umbilicus along the mid-clavicular line. After aseptic preparation of the puncture site and ultrasound probe, a needle will be advanced using an in-plane, lateral-to-medial approach under continuous ultrasound guidance. After correct needle-tip placement between the rectus abdominis muscle and the posterior rectus sheath, 30 mL of 0.25% bupivacaine with epinephrine 5 µg/mL will be injected on each side after negative aspiration. Local anesthetic spread will be monitored in real time, and the procedure will be repeated on the contralateral side using the same technique.
有源比较器：Transversus Abdominis Plane Block Group
Participants in this group will receive bilateral ultrasound-guided transversus abdominis plane block using 30 mL of 0.25% bupivacaine with epinephrine 5 µg/mL on each side, in addition to standard perioperative multimodal analgesia.
程序：Transversus Abdominis Plane Block
Bilateral transversus abdominis plane block will be performed by an anesthesiologist experienced in ultrasound-guided regional anesthesia. The ultrasound probe will be placed on the lateral abdominal wall between the costal margin and iliac crest at the mid-axillary line. Depth, frequency, and gain will be adjusted to clearly visualize the fascial plane between the internal oblique and transversus abdominis muscles. After aseptic preparation of the puncture site and ultrasound probe, a needle will be advanced using an in-plane approach under continuous ultrasound guidance. After correct needle-tip placement in the transversus abdominis plane, 30 mL of 0.25% bupivacaine with epinephrine 5 µg/mL will be injected on each side after negative aspiration. Local anesthetic spread within the fascial plane will be monitored in real time, and the procedure will be repeated on the contralateral side using the same technique.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Pain intensity during movement at 6 hours postoperatively (Pain-move-6hour)
大体时间：6 hours postoperatively
Pain intensity will be assessed using the Numerical Rating Scale (NRS), an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable. Patients will be asked to rate their pain intensity by selecting the number that best reflected their level of pain during movement at 6 h postoperatively. Patients will be instructed to perform a standardized movement (including coughing, deep breathing, or changing position from supine to sitting) and then rate the pain intensity experienced during that movement.
6 hours postoperatively

次要结果测量

结果测量
措施说明
大体时间
Pain intensity at rest and during movement
大体时间：0, 2, 6, 12, 24, and 48 hours postoperatively
Postoperative pain intensity will be assessed using the NRS. Pain scores will be recorded both at rest and movement at 0, 2, 6, 12, 24, and 48 hours (except for movement at 6 hours which was defined as primary outcome) (Pain-rest-0hour, Pain-rest-2hour, Pain-rest-6hour, Pain-rest-12hour, Pain-rest-24hour, Pain-rest-48hour and Pain-move-0hour, Pain-move-2hour, Pain-move-12hour, Pain-move-24hour, Pain-move-48hour) postoperatively. For pain at rest, patients will be asked to rate their pain while lying comfortably without active movement. For pain during movement, patients will be instructed to perform a standardized movement (including coughing, deep breathing, or changing position from supine to sitting) and then rate the pain intensity experienced during that movement.
0, 2, 6, 12, 24, and 48 hours postoperatively
Intraoperative fentanyl consumption
大体时间：During intraoperative period
Total intraoperative fentanyl consumption will be recorded for each patient and expressed in microgram. Fentanyl will be administered to standard clinical practice. The cumulative dose of fentanyl administered from induction of anesthesia until the end of surgery will be extracted from the anesthesia record
During intraoperative period
Area of sensory loss
大体时间：30 minutes postoperatively
The area of sensory loss will be assessed by testing for loss of cold sensation using a cold stimulus (ice). Sensory testing will be performed over the anterior abdominal wall, and dermatomal coverage will be recorded and mapped according to patient-reported loss of cold sensation compared with the contralateral or adjacent non-blocked area.
30 minutes postoperatively
Time to first rescue analgesia
大体时间：within 48 hours postoperatively
Time to first rescue analgesia will be defined as the interval, in minutes, from the end of surgery to the first activation (buttom press) of the patient-controlled analgesia (PCA) device. Data will be extracted from the PCA device electronic record
within 48 hours postoperatively
Postoperative opioid consumption
大体时间：0-24 hours and 24-48 hours postoperatively
Postoperative opioid consumption will be defined as the cumulative dose of opioids administered during the postoperative period and will be expressed as intravenous morphine milligram equivalents (MME). All opioid doses administered via patient-controlled analgesia (PCA) will be extracted from PCA device logs and converted to MME using standard conversion factors
0-24 hours and 24-48 hours postoperatively
QoR-14
大体时间：24 and 48 hours postoperatively
Postoperative quality of recovery will be assessed using the Thai version of the 14-item Quality of Recovery questionnaire (QoR-14), a validated patient-reported outcome measure. The QoR-14 evaluates multiple domains of postoperative recovery, including physical comfort, emotional state, physical independence, psychological support, and pain. Each item is scored on an 11-point numerical scale ranging from 0 to 10, yielding a total score from 0 to 140, with higher scores indicating a better quality of recovery.
24 and 48 hours postoperatively
Incidence and severity of nausea and vomiting
大体时间：0-2, 2-6, 6-12, 12-24 and 24-48 hours postoperatively.
The incidence and severity of postoperative nausea and vomiting will be assessed using a four-point numerical scale, where 0 = no nausea and vomiting, 1 = mild nausea, 2 = severe nausea or a single episode of vomiting, and 3 = more than one episode of vomiting.
0-2, 2-6, 6-12, 12-24 and 24-48 hours postoperatively.
Block-related complications
大体时间：Perioperative period
Block-related complication will include the occurrence of hematoma, intra-abdominal puncture, and local anesthetic systemic toxicity (LAST).
Perioperative period

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Chiang Mai University

调查人员

  • 首席研究员：Kittitorn Supphapipat, MD、Department of Anesthesiology, Faculty of Medicine, Chiang Mai University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月10日

初级完成 (估计的)

2030年12月31日

研究完成 (估计的)

2031年6月30日

研究注册日期

首次提交

2026年5月6日

首先提交符合 QC 标准的

2026年5月13日

首次发布 (实际的)

2026年5月18日

研究记录更新

最后更新发布 (实际的)

2026年5月18日

上次提交的符合 QC 标准的更新

2026年5月13日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ANE-2568-0679

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

Individual participant data will not be shared because this is a single-centre investigator-initiated study with a limited sample size, and the data contain potentially sensitive patient information. De-identified summary data may be made available upon reasonable request to the principal investigator

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅