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A Comparison of Two Regional Techniques for Bariatric Sleeve Gastrectomy

Primary Purpose

Bariatric Surgery Candidate, Weight Loss, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Bilateral Erector Spinae Plane Block
Abdominal Wall Blocks
Sponsored by
University College Hospital Galway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery Candidate focused on measuring Sleeve Gastrectomy, Regional Anaesthesia, Opioid Sparing Anaesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: BMI > 35 Undergoing laparoscopic sleeve gastrectomy surgery Ability to provide written informed consent ASA grade I-III Exclusion Criteria: 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

Sites / Locations

  • University Hospital GalwayRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bilateral Erector Spinae Plane Block

Abdominal Wall Blocks

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

QoR-15 score at 24h
The QoR-15 score will be taken by the outcome assessor on the post operative ward.

Secondary Outcome Measures

Pain scores at rest and on movement
Self reported pain scores using verbal rating scale
Time to first analgesia in recovery room
The time from end of surgery to first administration of analgesia in recovery
24hr opioid consumption
Total opioid consumption in oral morphine equivalents will be recorded at 24 hours
Length of stay
The length of stay in hospital from surgery to ready to discharge
Incidence of PONV/use of antiemetic rescue;
The self reported occurrence of any post operative nausea and vomiting and the total dose of antiemetics administered
Incidence and severity of postoperative complications using Comprehensive Complication Index calculator
The Comprehensive Complications Index Calculator will be used to assess for any complications related to surgery or anaesthesia.

Full Information

First Posted
April 20, 2023
Last Updated
May 1, 2023
Sponsor
University College Hospital Galway
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1. Study Identification

Unique Protocol Identification Number
NCT05839704
Brief Title
A Comparison of Two Regional Techniques for Bariatric Sleeve Gastrectomy
Official Title
Comparison of Bilateral Erector Spinae Plane Block Versus Serratus Anterior Plane Block Plus Subcostal Transversus Abdominus Plane Block for Bariatric Sleeve Gastrectomy Surgery: A Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Hospital Galway

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The World Health Organisation describes obesity as an excessive accumulation of fat that presents a risk to health. Obesity is commonly defined as a BMI of greater than 30. Obesity is a growing public health concern worldwide, with WHO statistics estimated in 2016 that 650 million people worldwide were obese, and this figure is predicted to rise annually. Obesity is an independent risk factor for a myriad of medical conditions, including but not limited to type 2 diabetes mellitus, obstructive sleep apnoea, hypertension, hyperlipidaemia and ischaemic heart disease. Obesity is also a difficult condition to treat, involving lifestyle modifications, psychological therapies, medical management and surgery. Limited long-term success of behavioural and pharmacological therapies in serious obesity have led to increasing interest in bariatric surgery. Surgery is considered for those patients who are suffering from complications of obesity, are at high risk of morbidity and mortality and who have not achieved adequate weight loss with lifestyle modification and medical management. Bariatric surgery can result in very substantial weight loss, resolution of obesity-related comorbidities and greatly improved quality of life for patients. Successful treatment of obesity via bariatric surgery has been shown to eliminate type two diabetes mellitus in up to 80% of patients. Bariatric surgery has been similarly shown to improve or eliminate obstructive sleep apnoea, hypertension and gastroesophageal reflux disease. During the past two decades, an increasing number of bariatric surgical procedures have been performed worldwide. The most prevalent procedures from 2000 - 2010 were gastric bypass or gastric banding surgeries. In the past decade however, laparoscopic sleeve gastrectomy has become increasingly popular. Sleeve gastrectomy is a permanent method of reducing the size of the stomach. The SLEEVEPASS (2018) and SM-BOSS (2018) trials conferred similar weight loss and improvement in comorbidities such as type 2 diabetes after sleeve gastrectomy when compared with gastric bypass, but with lower morbidity and mortality rates. Sleeve gastrectomy has also been shown to decrease concentrations of ghrelin, the human "hunger hormone", which may explain the reduction in hunger and rapid weight loss in many patients postoperatively. Unfortunately, bariatric surgery is frequently complicated by considerable postoperative pain, which can be difficult to manage. These patients often suffer from obstructive sleep apnoea and are at risk of respiratory dysfunction postoperatively, particularly when opioid analgesia is administered, with alternative analgesic methods preferred. The Guidelines for Perioperative Care in Bariatric Surgery, published in 2016, highlighted the successful use of regional analgesia techniques for bariatric surgical patients. The ERAS (Enhanced Recovery After Surgery) Society 2021 guidelines recommend opioid sparing analgesia, which is our current practice in UHG, with a note on lacking evidence regarding which specific regional anaesthesia approach is preferable. Several regional analgesic options exist, including serratus anterior plane block, transversus abdominis plane (TAP) block and quadratus laborum block. Abdominal wall blocks such as the transversus abdominus plane block have been investigated with equivocal results, likely in part because they provide only somatic analgesia. At present in University Hospital Galway, the method utilised for regional analgesia for the majority of laparoscopic sleeve gastrectomy surgery is a combination of both serratus anterior plane block and subcostal TAP block. The erector spinae plane block (ESB) is a relatively novel regional anaesthesia technique first described in 2016. A very limited number of studies to date have been performed regarding ESB in bariatric surgery, with early indications suggesting that it may provide an opportunity to provide increased postoperative analgesia in this cohort of patients. An extensive literature review revealed a total of four randomised trials investigating the efficacy of ESB in bariatric surgery patients. Two of these trials compare ESB vrs. no block, while two compare ESB vrs. TAP block. To date, there have been no clinical trials or case reports published comparing erector spinae plane block vrs the combination of both serratus anterior plane block and subcostal TAP block in laparoscopic sleeve gastrectomy patients. This study aims to contribute to filling this gap in the literature by examining quality of recovery postoperatively to establish whether there is a difference between analgesia provided by erector spinae plane block versus that provided by serratus anterior plane block + subcostal TAP block in this cohort of patients. Of note, all patients undergoing this surgery in UHG would usually receive a regional analgesia technique, regardless of their enrolment in this study. The aim of this study is to compare the two regional analgesia techniques to identify the more efficacious approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Weight Loss, Surgery
Keywords
Sleeve Gastrectomy, Regional Anaesthesia, Opioid Sparing Anaesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bilateral Erector Spinae Plane Block
Arm Type
Experimental
Arm Description
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.
Arm Title
Abdominal Wall Blocks
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bilateral Erector Spinae Plane Block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Abdominal Wall Blocks
Intervention Description
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
Primary Outcome Measure Information:
Title
QoR-15 score at 24h
Description
The QoR-15 score will be taken by the outcome assessor on the post operative ward.
Time Frame
24 hours after the block is administered
Secondary Outcome Measure Information:
Title
Pain scores at rest and on movement
Description
Self reported pain scores using verbal rating scale
Time Frame
24 hours after block administration
Title
Time to first analgesia in recovery room
Description
The time from end of surgery to first administration of analgesia in recovery
Time Frame
Immediate post op recovery up to 24 hours
Title
24hr opioid consumption
Description
Total opioid consumption in oral morphine equivalents will be recorded at 24 hours
Time Frame
24 hours post block administration
Title
Length of stay
Description
The length of stay in hospital from surgery to ready to discharge
Time Frame
30 days
Title
Incidence of PONV/use of antiemetic rescue;
Description
The self reported occurrence of any post operative nausea and vomiting and the total dose of antiemetics administered
Time Frame
24 hours post block administration
Title
Incidence and severity of postoperative complications using Comprehensive Complication Index calculator
Description
The Comprehensive Complications Index Calculator will be used to assess for any complications related to surgery or anaesthesia.
Time Frame
30 days post op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI > 35 Undergoing laparoscopic sleeve gastrectomy surgery Ability to provide written informed consent ASA grade I-III Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Cosgrave
Phone
091544074
Email
davidw.cosgrave@hse.ie
Facility Information:
Facility Name
University Hospital Galway
City
Galway
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Cosgrave, MDBChBAOFCAI
Phone
091544074
Email
davidw.cosgrave@hse.ie

12. IPD Sharing Statement

Learn more about this trial

A Comparison of Two Regional Techniques for Bariatric Sleeve Gastrectomy

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