NCT07592091

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
62mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Jun 2031

First Submitted

Initial submission to the registry

May 6, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

May 10, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2031

Last Updated

May 18, 2026

Status Verified

April 1, 2026

Enrollment Period

4.6 years

First QC Date

May 6, 2026

Last Update Submit

May 13, 2026

Conditions

Keywords

Rectus Sheath BlockTransversus abdominis plane blockLaparoscopic bariatric surgeryopioid consumptionanalgesia

Outcome Measures

Primary Outcomes (1)

  • Pain intensity during movement at 6 hours postoperatively (Pain-move-6hour)

    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

Secondary Outcomes (8)

  • Pain intensity at rest and during movement

    0, 2, 6, 12, 24, and 48 hours postoperatively

  • Intraoperative fentanyl consumption

    During intraoperative period

  • Area of sensory loss

    30 minutes postoperatively

  • Time to first rescue analgesia

    within 48 hours postoperatively

  • Postoperative opioid consumption

    0-24 hours and 24-48 hours postoperatively

  • +3 more secondary outcomes

Study Arms (2)

Rectus Sheath Block Group

EXPERIMENTAL

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.

Procedure: Rectus Sheath Block

Transversus Abdominis Plane Block Group

ACTIVE COMPARATOR

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.

Procedure: Transversus Abdominis Plane Block

Interventions

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.

Rectus Sheath Block Group

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.

Transversus Abdominis Plane Block Group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University

Chiang Mai, Mueang, 50200, Thailand

Location

Related Publications (2)

  • Xue Q, Chu Z, Zhu J, Zhang X, Chen H, Liu W, Jia B, Zhang Y, Wang Y, Huang C, Hu X. Analgesic Efficacy of Transverse Abdominis Plane Block and Quadratus Lumborum Block in Laparoscopic Sleeve Gastrectomy: A Randomized Double-Blinded Clinical Trial. Pain Ther. 2022 Jun;11(2):613-626. doi: 10.1007/s40122-022-00373-1. Epub 2022 Mar 21.

  • Samerchua A, Tepmalai K, Chakrabandhu B, Supphapipat K, Lapisatepun P, Leurcharusmee P, Prapussarakul K, Jinadech T, Jungsakulrujirek K, Wanvoharn M. Analgesic Effect of Rectus Sheath Block Versus Local Infiltration Analgesia in Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Trial. Obes Surg. 2026 Jan;36(1):182-192. doi: 10.1007/s11695-025-08405-3. Epub 2025 Dec 4.

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kittitorn Supphapipat, MD

    Department of Anesthesiology, Faculty of Medicine, Chiang Mai University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kittitorn Supphapipat, MD

CONTACT

Artid Samerchua, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either rectus sheath block or transversus abdominis plane block. Outcomes will be assessed at multiple postoperative time points
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor, Department of Anesthesiology, Faculty of Medicine, Chiang Mai University

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 18, 2026

Study Start

May 10, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

June 30, 2031

Last Updated

May 18, 2026

Record last verified: 2026-04

Locations