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Modified TAP (Transverse Abdominis Plane) Block in Colorectal Surgery
Phase 4
Waitlist Available
Led By Charles Whitlow, MD
Research Sponsored by Ochsner Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Patients age 18-75 years undergoing planned laparoscopic colon or rectal resection
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up daily through study completion (up to 30 days)
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Approved for 10 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Summary
Single Blind, Randomized Controlled study to see if TAP Block with Exparel provides better pain relief than TAP Block with bupivicaine. Differences in Pain Scale, Length of Stay, and Total Narcotic use in the hospital will be evaluated.
Eligible Conditions
- Infections
- Postoperative Pain
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ daily through study completion (up to 30 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~daily through study completion (up to 30 days)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pain Scale
Secondary study objectives
Length of stay
Narcotic use
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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TAP Block with ExparelExperimental Treatment2 Interventions
TAP Block with 20 mL (266mg) of liposomal bupivacaine with 25 mL (5 mg/mL) of bupivacaine diluted in 55 mL of normal saline
Group II: TAP Block with bupivicaineActive Control2 Interventions
TAP Block with 30 mL (5mg/mL) of bupivacaine diluted in 70 mL of normal saline
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved
Find a Location
Who is running the clinical trial?
Ochsner Health SystemLead Sponsor
96 Previous Clinical Trials
91,824 Total Patients Enrolled
3 Trials studying Infections
2,381 Patients Enrolled for Infections
Charles Whitlow, MDPrincipal InvestigatorOchsner