A Comparison of Two Regional Techniques for Bariatric Sleeve Gastrectomy

NCT05839704 | Unknown

• 1 other identifier: NUIG-2023-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Regional anaesthetic techniques, or nerve blocks, are commonly used to provide postoperative pain relief for patients undergoing surgery. At present in University Hospital Galway, it is standard practice for patients undergoing bariatric sleeve gastrectomy surgery to receive a regional anaesthetic technique to improve their postoperative pain. There are a number of different regional anaesthetic options available for this surgery, but as yet, published evidence regarding which specific approach confers most benefit for patients is lacking. This study aims to compare two regional anaesthetic techniques - erector spinae plane blockade versus serratus anterior plane blockade plus subcostal transversus abdominus plane blockade - and assess if one approach provides a superior quality of recovery postoperatively for sleeve gastrectomy patients over the other.

Conditions

Bariatric Surgery Candidate; Weight Loss; Surgery

Keywords

Sleeve Gastrectomy; Regional Anaesthesia; Opioid Sparing Anaesthesia

Outcome Measures

Primary Outcomes (1)

• QoR-15 score at 24h

  The QoR-15 score will be taken by the outcome assessor on the post operative ward.

  24 hours after the block is administered

Secondary Outcomes (6)

• Pain scores at rest and on movement

  24 hours after block administration

• Time to first analgesia in recovery room

  Immediate post op recovery up to 24 hours

• 24hr opioid consumption

  24 hours post block administration

• Length of stay

  30 days

• Incidence of PONV/use of antiemetic rescue;

  24 hours post block administration

Study Arms (2)

Bilateral Erector Spinae Plane Block

EXPERIMENTAL

Patients in this arm will receive standard anaesthesia as per our bariatric anaesthesia protocol. They will also receive preoperative ultrasound guided bilateral single shot erector spinae plane blocks at the level of the 8th transverse process.

Procedure: Bilateral Erector Spinae Plane Block

Abdominal Wall Blocks

ACTIVE COMPARATOR

Patients in this arm will receive standard anaesthesia as per our bariatric anaesthesia protocol. They will also receive bilateral subcostal transversus abdominus plane blocks and a left sided serrratus plane block, postoperatively, while under general anaesthetic.

Procedure: Abdominal Wall Blocks

Interventions

Bilateral Erector Spinae Plane Block PROCEDURE

Patient will receive local ropivacaine 0.75% with lignocaine 1% with adrenaline, administered under ultrasound into the erector spinae plane at the level of T8.

Bilateral Erector Spinae Plane Block

Abdominal Wall Blocks PROCEDURE

Patient will receive local ropivacaine 0.75% with lignocaine 1% with adrenaline, administered under ultrasound into the subcostal transversus abdominus plane bilaterally and the serratus plane on the left side

Abdominal Wall Blocks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \> 35
• Undergoing laparoscopic sleeve gastrectomy surgery
• Ability to provide written informed consent
• ASA grade I-III

You may not qualify if:

• Inability to provide informed consent
• Pre-existing infection at block site
• Severe coagulopathy
• Allergy to local anaesthesia
• Previous history of chronic pain condition
• Previous history of opioid dependence/abuse
• Predicted inability to cooperate with completion of QoR-15 score on postoperative day 1
• Postoperative admission to ICU for prolonged ventilation postoperatively

Sponsors & Collaborators

• University College Hospital Galway: lead

Study Sites (1)

University Hospital Galway

Galway, Ireland

RECRUITING

Related Publications (1)

• Wiseman PN, Van der Walt M, O'Riordan M, Brosnan K, Shaikh M, Cosgrave D. A comparison of efficacy of erector spinae plane block versus serratus anterior plane block plus subcostal transversus abdominus plane block for bariatric laparoscopic sleeve gastrectomy surgery: study protocol for a randomised clinical trial. Trials. 2024 Sep 28;25(1):634. doi: 10.1186/s13063-024-08472-4.

  PMID: 39342346 DERIVED

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

David Cosgrave

CONTACT

091544074; davidw.cosgrave@hse.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The patient, care provider and primary investigator will not be blinded to the intervention. The outcomes assessor who collects the post operative data will be blinded to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr David Cosgrave

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 3, 2023
• Study Start: March 2, 2023
• Primary Completion: December 31, 2023
• Study Completion: July 30, 2024
• Last Updated: May 3, 2023

Record last verified: 2023-04

Locations

IE (1)