Study to Determine if Pre- and Post- Operative TAP Catheters With Ropivacaine Versus Placebo Affects Anesthetic, Narcotic Dosing, and Pain Scores
NCT03149783 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2021-05-27
Summary
A randomized controlled trial to determine if pre- and post- operative regional pain control (transversus abdominis plane block) with ropivacaine versus placebo leads to lower anesthetic and narcotic dosing, and alters pain scores.
This study plans to learn more about regional anesthesia and pain control during abdominal surgery. The study will gather data about the effectiveness of continuous catheter infusion of local anesthetic after an abdominal operation. Outcomes include pain scores, IV pain medicine requirements, and delirium.
Conditions
- Pain, Postoperative
- Delirium
- Anesthesia, Local
Interventions
- DRUG
-
Ropivacaine HCL
Ropivacaine injected after placement of catheters, then infused during the operation
- DRUG
-
sodium chloride
Placebo
Sponsors & Collaborators
-
University of Colorado, Denver
lead OTHER
Principal Investigators
-
Thomas Robinson, MD · University of Colorado, Denver
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-13
- Primary Completion
- 2021-08-31
- Completion
- 2021-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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