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

2026년 5월 13일 업데이트: 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

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

96

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 태국
    • Mueang
      • Chiang Mai, Mueang, 태국, 50200
        • Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Artid Samerchua, MD
        • 수석 연구원:
          • Kittitorn Supphapipat, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
절차: 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.
활성 비교기: 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.
절차: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pain intensity during movement at 6 hours postoperatively (Pain-move-6hour)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Pain intensity at rest and during movement
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Perioperative period
Block-related complication will include the occurrence of hematoma, intra-abdominal puncture, and local anesthetic systemic toxicity (LAST).
Perioperative period

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Chiang Mai University

수사관

  • 수석 연구원: Kittitorn Supphapipat, MD, Department of Anesthesiology, Faculty of Medicine, Chiang Mai University

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 10일

기본 완료 (추정된)

2030년 12월 31일

연구 완료 (추정된)

2031년 6월 30일

연구 등록 날짜

최초 제출

2026년 5월 6일

QC 기준을 충족하는 최초 제출

2026년 5월 13일

처음 게시됨 (실제)

2026년 5월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 13일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ANE-2568-0679

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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