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Rectus Sheath BlockRSB-TAPBNCT07592091

Rectus Sheath Block Versus Transversus Abdominis Plane Block for Analgesia in Laparoscopic Bariatric Surgery

A study testing Rectus Sheath Block and Transversus Abdominis Plane Block in people with Rectus Sheath Block and Transverse Abdominis Plane Block, run by Chiang Mai University at 1 site in Thailand.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 60 years
What is being tested?
Rectus Sheath Block and Transversus Abdominis Plane Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteThailand
Study dates
10 May 2026to 30 Jun 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kittitorn Supphapipat, MD contact

+66891920066

kittitorn.pans@gmail.com

Artid Samerchua, MD contact

+66826944496

artidsamerchua@gmail.com

Thailand1 site
  • Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University

    Chiang Mai, Mueang, 50200

    Kittitorn Supphapipat, MD, +66891920066, kittitorn.pans@gmail.com

    Artid Samerchua, MD, +66826944496, artidsamerchua@gmail.com

Other trials in Thailand

About this study

Official title: 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

Read the detailed description

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.

Being tested
Rectus Sheath Block, Transversus Abdominis Plane Block
Keywords
Rectus Sheath Block, Transversus abdominis plane block, Laparoscopic bariatric surgery, opioid consumption, analgesia
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rectus Sheath BlockProcedure or surgery

    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.

  • Transversus Abdominis Plane BlockProcedure or surgery

    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.

Study groups in NCT07592091
Study groupRoleWhat they receive
Rectus Sheath Block GroupExperimentalParticipants 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.
Receives: Procedure: Rectus Sheath Block
Transversus Abdominis Plane Block GroupActive comparatorParticipants 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.
Receives: Procedure: Transversus Abdominis Plane Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 hours postoperatively

Secondary outcomes (8)
  1. Pain intensity at rest and during movement

    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.

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

  2. Intraoperative fentanyl consumption

    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

    Measured: During intraoperative period

  3. Area of sensory loss

    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.

    Measured: 30 minutes postoperatively

  4. Time to first rescue analgesia

    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

    Measured: within 48 hours postoperatively

  5. Postoperative opioid consumption

    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

    Measured: 0-24 hours and 24-48 hours postoperatively

  6. QoR-14

    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.

    Measured: 24 and 48 hours postoperatively

  7. Incidence and severity of nausea and vomiting

    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.

    Measured: 0-2, 2-6, 6-12, 12-24 and 24-48 hours postoperatively.

  8. Block-related complications

    Block-related complication will include the occurrence of hematoma, intra-abdominal puncture, and local anesthetic systemic toxicity (LAST).

    Measured: Perioperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2026
  2. Study start10 May 2026 (estimated)
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion30 Jun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07592091
Sponsor's protocol ID
ANE-2568-0679
Acronym
RSB-TAPB
Status last verified
Apr 2026
First submitted
6 May 2026
Last updated
18 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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

Publications

  • 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.

    PubMed 35312948
  • 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.

    PubMed 41345817

Questions about this trial

What is this clinical trial studying?

A study testing Rectus Sheath Block and Transversus Abdominis Plane Block in people with Rectus Sheath Block and Transverse Abdominis Plane Block, run by Chiang Mai University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kittitorn Supphapipat, MD (+66891920066, kittitorn.pans@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity during movement at 6 hours postoperatively (Pain-move-6hour) (time frame: 6 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07592091, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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