Bariatric Surgery CandidatePhase 4LapTAPNCT03367728
The Use of Laparoscopic Transversus Abdominis Plane Block in Gastric Bypass Surgery (LapTAP)
A Phase 4 study testing Ropivacaine and Normal saline in people with Bariatric Surgery Candidate, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Randomized, Double-Blinded, Placebo-Controlled Trial of Laparoscopic Transverse Abdominis Plane (Lap TAP) and Rectus Sheath Block in elective Gastric Bypass Surgery aiming to evaluate the benefit of a laparoscopically -guided, surgical transversus abdominis plane (TAP) block and rectus sheath block in reducing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Ropivacaine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteCanada
- Study dates
- 27 Nov 2018to 6 Mar 2020
- Phase
- Phase 4
- 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
- Patients undergoing Roux-en-Y gastric bypass surgery;
- Patients who able to tolerate general anesthetic and pneumoperitoneum;
- Patients who able to provide informed consent for the surgery;
- Patients over the age of 18 years;
Who cannot join
- Patient undergoing planned sleeve gastrectomy (intra-op conversion to sleeve gastrectomy after delivery of Ropivacaine/placebo will be included and analyzed using intention-to-treat approach)
- Patients with an allergy to local anesthetics
- Patients with severe underlying cardiovascular disease (ie: congestive heart failure, conduction abnormalities, and ischemic heart disease)
- Patients with chronic renal disease Stage 3 or greater (Creatinine clearance less than 60mL/min)
- Patients with hepatic dysfunction Child-Pugh Class B or C
- Patients with previous foregut surgery including esophageal, gastric, liver, and pancreas resections
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- Patients weighing less than or equal to 100 kilograms as measured in the pre-admission unit
- Patients enrolled in any other study involving involve tissue biopsy.
- Patients with Chronic Pain and Chronic Opioid use- Oral Morphine Equivalent of >100mg/day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Role of Laparoscopic Transversus Abdominis Plane Block in Gastric Bypass Surgery (LapTAP Trial)
Randomized, Double-Blinded, Placebo-Controlled Trial of Laparoscopic Transverse Abdominis Plane (Lap TAP) and Rectus Sheath Block in elective Gastric Bypass Surgery aiming to evaluate the benefit of a laparoscopically -guided, surgical transversus abdominis plane (TAP) block and rectus sheath block in reducing post-operative opioid consumption and improving outcomes in patients undergoing laparoscopic gastric bypass surgery. The results of this study will provide further evidence on the optimal means to obtain analgesia in patients undergoing gastric bypass surgery
Read the detailed description
Management of post-operative pain remains a major challenge and an area of continued research. Effective pain control, apart from providing general patient comfort, is critical for a variety of clinical reasons. It leads to early ambulation and improved respiratory function, which significantly reduces the risk of post-operative complications such as pulmonary embolus or pneumonia, as well as early discharge.
Post-operative pain management was typically opioid-based; however, post-operative opioid use may be associated with increased risk of respiratory depression and sedation. It is therefore desirable to implement opioid sparing multimodal analgesia to achieve satisfactory pain control while reducing post-operative opioid requirements and their side-effects.
Rational pain management is a particularly pertinent issue in the patients with morbid obesity (MO). The pathophysiology of obesity, the high prevalence of obstructive sleep apnea, and high susceptibility to respiratory depression amongst patients with MO make safe analgesic (pain) management especially difficult. These individuals are at high risk of post-operative adverse respiratory events, nosocomial infections, cardiovascular complications, and pulmonary emboli (the second leading cause of death in the bariatric surgery population).
Given the increasing number of patients with MO presenting for elective weight loss surgery, it is important to understand and optimize the analgesic requirements of this patient population. However, there are limited evidence-based recommendations and no ideal analgesic regimen exists for patients with MO. Current recommendations include use of step-wise severity-based opioid- sparing multimodal analgesia. It is possible that including local anesthetic blocks will further reduce pain, opioid analgesic consumption and side-effects from pain management (sedation, confusion, nausea \& vomiting etc.) at-risk patient population.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Ropivacaine, Normal saline
- Keywords
- Bariatric Surgery, Bariatrics, Ropivacaine, Randomized Controlled Trial, Enhanced Recovery After Bariatric Surgery, TAP Block, Rectus Sheath Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called NAROPIN®, 84057-95-4
TAP and Rectus Sheath Block Injections of Ropivacaine
Normal salineDrug
Also called Sodium Chloride, 7647-14-5
TAP and Rectus Sheath Block Injections of Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| TAP and Rectus Sheath Normal Saline | Placebo comparator | TAP and Rectus Sheath Block of 60 mL Normal Saline divided into 4 injections administered as in Experimental Arm. Receives: Drug: Normal saline |
| TAP and Rectus Sheath ropivacaine | Experimental | The block will be administered in the anterior abdominal wall. For the TAP block, the standard technique will be followed- at the anterior axillary line midway between the subcostal margin and iliac crest. For the rectus sheath block, a bilateral sub-xiphoid approach will be used. There will be 4 injection sites in total and the size of the needle will be standardized to an 18g spinal needle 10cms. Using laparoscopic visualization, the transversus abdominis muscles were identified lateral to the semilunar line. Ropivacaine to be infiltrated will be divided into 4 equal amounts. The procedure is then repeated 2 times in the transversus abdominis plane (20mL each) and 2 times as a Rectus Sheath Block (10mL each) with a total amount of 60 mL. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative postoperative narcotic use
Cumulative postoperative narcotic use administered within 24 hours post-operatively
Measured: Hour 0-24 post operatively, baseline and Follow-up use of narcotics will be recorded for population description
Secondary outcomes (4)
Peak Expiratory flow score
measured by the spirometry 60 - 850 liters per minute. Peak expiratory force has not been studied extensively in obese patients. Currently, there is no recommendation on what constitutes a clinically significant change. Recovery to baseline will be sought.
Measured: Surgery consent visit, morning of surgery, Hour 0-24 post operatively, Follow-up (7-10 days post op)
Pain score
measured by the 0-10 Numeric pain rating score
Measured: Surgery consent visit, morning of surgery, Hour 0-24 post operatively, Follow-up (7-10 days post op)
6-minute walk distance (6MWD)
the distance (m) an individual is able to walk along a flat 30 m walkway over a six-minute period, with breaks as required
Measured: Surgery consent visit, morning of surgery, Hour 0-24 post operatively, Follow-up (7-10 days post op)
Quality of Life Questionnaire (QOR-40) (Explanatory Outcome)
Assessment of different aspects of quality of life using validated questionnaire
Measured: Surgery consent visit, morning of surgery, Hour 0-24 post operatively, Follow-up (7-10 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 posted11 Dec 2017
- Study start27 Nov 2018
- Primary completion28 Feb 2020
- Study completion6 Mar 2020
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.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Mamazza, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367728
- Sponsor's protocol ID
- 20170749-01H
- Acronym
- LapTAP
- Status last verified
- Aug 2026
- First submitted
- 5 Dec 2017
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon request and all data requests have to be approved by our institution research ethics board
Publications
Jarrar A, Budiansky A, Eipe N, Walsh C, Kolozsvari N, Neville A, Mamazza J. Randomised, double-blinded, placebo-controlled trial to investigate the role of laparoscopic transversus abdominis plane block in gastric bypass surgery: a study protocol. BMJ Open. 2020 Jun 28;10(6):e025818. doi: 10.1136/bmjopen-2018-025818.
PubMed 32595142
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate the Role of Laparoscopic Transversus Abdominis Plane Block in Gastric Bypass Surgery (LapTAP Trial)
- ClinicalTrials.gov ID
- NCT03367728
- Acronym / sponsor ID
- LapTAP / 20170749-01H
- Conditions
- Bariatric Surgery Candidate
- Keywords
- Bariatric Surgery, Bariatrics, Ropivacaine, Randomized Controlled Trial, Enhanced Recovery After Bariatric Surgery, TAP Block, Rectus Sheath Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 11 Dec 2017 (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.
Randomized, Double-Blinded, Placebo-Controlled Trial of Laparoscopic Transverse Abdominis Plane (Lap TAP) and Rectus Sheath Block in elective Gastric Bypass Surgery aiming to evaluate the benefit of a laparoscopically -guided, surgical transversus abdominis plane (TAP) block and rectus sheath block in reducing post-operative opioid consumption and improving outcomes in patients undergoing laparoscopic gastric bypass surgery. The results of this study will provide further evidence on the optimal means to obtain analgesia in patients undergoing gastric bypass surgery
Detailed description
Management of post-operative pain remains a major challenge and an area of continued research. Effective pain control, apart from providing general patient comfort, is critical for a variety of clinical reasons. It leads to early ambulation and improved respiratory function, which significantly reduces the risk of post-operative complications such as pulmonary embolus or pneumonia, as well as early discharge.
Post-operative pain management was typically opioid-based; however, post-operative opioid use may be associated with increased risk of respiratory depression and sedation. It is therefore desirable to implement opioid sparing multimodal analgesia to achieve satisfactory pain control while reducing post-operative opioid requirements and their side-effects.
Rational pain management is a particularly pertinent issue in the patients with morbid obesity (MO). The pathophysiology of obesity, the high prevalence of obstructive sleep apnea, and high susceptibility to respiratory depression amongst patients with MO make safe analgesic (pain) management especially difficult. These individuals are at high risk of post-operative adverse respiratory events, nosocomial infections, cardiovascular complications, and pulmonary emboli (the second leading cause of death in the bariatric surgery population).
Given the increasing number of patients with MO presenting for elective weight loss surgery, it is important to understand and optimize the analgesic requirements of this patient population. However, there are limited evidence-based recommendations and no ideal analgesic regimen exists for patients with MO. Current recommendations include use of step-wise severity-based opioid- sparing multimodal analgesia. It is possible that including local anesthetic blocks will further reduce pain, opioid analgesic consumption and side-effects from pain management (sedation, confusion, nausea \& vomiting etc.) at-risk patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP and Rectus Sheath Normal Saline | Placebo comparator | Drug: Normal salineTAP and Rectus Sheath Block of 60 mL Normal Saline divided into 4 injections administered as in Experimental Arm. |
| TAP and Rectus Sheath ropivacaine | Experimental | Drug: RopivacaineThe block will be administered in the anterior abdominal wall. For the TAP block, the standard technique will be followed- at the anterior axillary line midway between the subcostal margin and iliac crest. For the rectus sheath block, a bilateral sub-xiphoid approach will be used. There will be 4 injection sites in total and the size of the needle will be standardized to an 18g spinal needle 10cms. Using laparoscopic visualization, the transversus abdominis muscles were identified lateral to the semilunar line. Ropivacaine to be infiltrated will be divided into 4 equal amounts. The procedure is then repeated 2 times in the transversus abdominis plane (20mL each) and 2 times as a Rectus Sheath Block (10mL each) with a total amount of 60 mL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing Roux-en-Y gastric bypass surgery;
- Patients who able to tolerate general anesthetic and pneumoperitoneum;
- Patients who able to provide informed consent for the surgery;
- Patients over the age of 18 years;
Key exclusion criteria (9 listed)
- Patient undergoing planned sleeve gastrectomy (intra-op conversion to sleeve gastrectomy after delivery of Ropivacaine/placebo will be included and analyzed using intention-to-treat approach)
- Patients with an allergy to local anesthetics
- Patients with severe underlying cardiovascular disease (ie: congestive heart failure, conduction abnormalities, and ischemic heart disease)
- Patients with chronic renal disease Stage 3 or greater (Creatinine clearance less than 60mL/min)
- Patients with hepatic dysfunction Child-Pugh Class B or C
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 |
|---|---|---|
| RopivacaineAlso: NAROPIN®, 84057-95-4TAP and Rectus Sheath Block Injections of Ropivacaine | Drug | TAP and Rectus Sheath ropivacaine |
| Normal salineAlso: Sodium Chloride, 7647-14-5TAP and Rectus Sheath Block Injections of Normal Saline | Drug | TAP and Rectus Sheath Normal Saline |
Primary outcome
Cumulative postoperative narcotic use
Time frame: Hour 0-24 post operatively, baseline and Follow-up use of narcotics will be recorded for population description
Cumulative postoperative narcotic use administered within 24 hours post-operatively
4 secondary outcomes
Peak Expiratory flow score
Time frame: Surgery consent visit, morning of surgery, Hour 0-24 post operatively, Follow-up (7-10 days post op)
Pain score
Time frame: Surgery consent visit, morning of surgery, Hour 0-24 post operatively, Follow-up (7-10 days post op)
6-minute walk distance (6MWD)
Time frame: Surgery consent visit, morning of surgery, Hour 0-24 post operatively, Follow-up (7-10 days post op)
Quality of Life Questionnaire (QOR-40) (Explanatory Outcome)
Time frame: Surgery consent visit, morning of surgery, Hour 0-24 post operatively, Follow-up (7-10 days post op)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Derived from this study: PubMed 32595142Jarrar A, Budiansky A, Eipe N, Walsh C, Kolozsvari N, Neville A, Mamazza J. Randomised, double-blinded, placebo-controlled trial to investigate the role of laparoscopic transversus abdominis plane block in gastric bypass surgery: a study protocol. BMJ Open. 2020 Jun 28;10(6):e025818. doi: 10.1136/bmjopen-2018-025818.
- Individual participant dataSharing planned: Yes. Available upon request and all data requests have to be approved by our institution research ethics board
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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.
Joseph Mamazza, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine and Normal saline in people with Bariatric Surgery Candidate, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 9 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: finished, as of the sponsor's last update on 31 Aug 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative postoperative narcotic use (time frame: Hour 0-24 post operatively, baseline and Follow-up use of narcotics will be recorded for population description). 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 NCT03367728, 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 31 Aug 2026.