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TAP and Rectus Sheath ropivacaine for Bariatric Surgery Candidates (LapTAP Trial)

Phase 4

Waitlist Available

Led By Joseph Mamazza, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-24 hour post operatively

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Drug Has Already Been Approved

Pivotal 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 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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ hour 0-24 post operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~hour 0-24 post operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and hour 0-24 post operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cumulative postoperative narcotic use

Secondary study objectives

6-minute walk distance (6MWD)

Peak Expiratory flow score

Post-operative pain score

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TAP and Rectus Sheath ropivacaineExperimental Treatment1 Intervention

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.

Group II: TAP and Rectus Sheath Normal SalinePlacebo Group1 Intervention

TAP and Rectus Sheath Block of 60 mL Normal Saline divided into 4 injections administered as in Experimental Arm.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ropivacaine

FDA approved

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