Bariatric Surgery CandidateNCT05839704
A Comparison of Two Regional Techniques for Bariatric Sleeve Gastrectomy
A study testing Bilateral Erector Spinae Plane Block and Abdominal Wall Blocks in people with Bariatric Surgery Candidate and Weight Loss, run by University College Hospital Galway at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate, Weight Loss, Surgery
- What is being tested?
- Bilateral Erector Spinae Plane Block and Abdominal Wall Blocks
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIreland
- Study dates
- 2 Mar 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI > 35
- Undergoing laparoscopic sleeve gastrectomy surgery
- Ability to provide written informed consent
- ASA grade I-III
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
University Hospital Galway
Galway
David Cosgrave, MDBChBAOFCAI, 091544074, davidw.cosgrave@hse.ie
About this study
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
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.
Read the 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.
- Conditions
- Bariatric Surgery Candidate, Weight Loss, Surgery
- Being tested
- Bilateral Erector Spinae Plane Block, Abdominal Wall Blocks
- Keywords
- Sleeve Gastrectomy, Regional Anaesthesia, Opioid Sparing Anaesthesia
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Erector Spinae Plane BlockProcedure or surgery
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.
Abdominal Wall BlocksProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Abdominal Wall Blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
QoR-15 score at 24h
The QoR-15 score will be taken by the outcome assessor on the post operative ward.
Measured: 24 hours after the block is administered
Secondary outcomes (6)
Pain scores at rest and on movement
Self reported pain scores using verbal rating scale
Measured: 24 hours after block administration
Time to first analgesia in recovery room
The time from end of surgery to first administration of analgesia in recovery
Measured: Immediate post op recovery up to 24 hours
24hr opioid consumption
Total opioid consumption in oral morphine equivalents will be recorded at 24 hours
Measured: 24 hours post block administration
Length of stay
The length of stay in hospital from surgery to ready to discharge
Measured: 30 days
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
Measured: 24 hours post block administration
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.
Measured: 30 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start2 Mar 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Hospital Galway
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Laffey, University College Hospital Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05839704
- Sponsor's protocol ID
- NUIG-2023-001
- Status last verified
- Apr 2023
- First submitted
- 20 Apr 2023
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39342346
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05839704
- Acronym / sponsor ID
- NUIG-2023-001
- Conditions
- Bariatric Surgery Candidate, Weight Loss, Surgery
- Keywords
- Sleeve Gastrectomy, Regional Anaesthesia, Opioid Sparing Anaesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University College Hospital GalwayUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 3 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral Erector Spinae Plane Block | Experimental | Procedure: Bilateral Erector Spinae Plane BlockPatients 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. |
| Abdominal Wall Blocks | Active comparator | Procedure: Abdominal Wall BlocksPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI > 35
- Undergoing laparoscopic sleeve gastrectomy surgery
- Ability to provide written informed consent
- ASA grade I-III
Key exclusion criteria (8 listed)
- Inability to provide informed consent
- Pre-existing infection at block site
- Severe coagulopathy
- Allergy to local anaesthesia
- Previous history of chronic pain condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral Erector Spinae Plane BlockPatient will receive local ropivacaine 0.75% with lignocaine 1% with adrenaline, administered under ultrasound into the erector spinae plane at the level of T8. | Procedure or surgery | Bilateral Erector Spinae Plane Block |
| Abdominal Wall BlocksPatient 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 | Procedure or surgery | Abdominal Wall Blocks |
Primary outcome
QoR-15 score at 24h
Time frame: 24 hours after the block is administered
The QoR-15 score will be taken by the outcome assessor on the post operative ward.
6 secondary outcomes
Pain scores at rest and on movement
Time frame: 24 hours after block administration
Time to first analgesia in recovery room
Time frame: Immediate post op recovery up to 24 hours
24hr opioid consumption
Time frame: 24 hours post block administration
Length of stay
Time frame: 30 days
Incidence of PONV/use of antiemetic rescue;
Time frame: 24 hours post block administration
Incidence and severity of postoperative complications using Comprehensive Complication Index calculator
Time frame: 30 days post op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Derived from this study: PubMed 39342346Wiseman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Erector Spinae Plane Block and Abdominal Wall Blocks in people with Bariatric Surgery Candidate and Weight Loss, run by University College Hospital Galway at 1 site in Ireland.
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 8 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: status not confirmed, as of the sponsor's last update on 3 May 2023. 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 Ireland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Cosgrave (091544074, davidw.cosgrave@hse.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QoR-15 score at 24h (time frame: 24 hours after the block is administered). 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 NCT05839704, which also lists 1 linked publication.
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 3 May 2023.