Study to Determine if Pre- and Post- Operative TAP Catheters With Ropivacaine Versus Placebo Affects Anesthetic, Narcotic Dosing, and Pain Scores

Phase 2

• Conditions: Pain, Postoperative; Anesthesia, Local; Delirium
• Interventions: Drug: Ropivacaine HCL; Drug: sodium chloride

• Registration Number: NCT03149783
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-05-10
• Study First Posted: 2017-05-11
• Study Start: 2018-02-13
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-05-27
• Primary Completion: 2021-08-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Age >=50 years.
• Subjects will be undergoing an elective intra-abdominal or abdominal wall operation, including pelvic operations. Surgery specialties included are general surgery, surgical oncology, urology, gynecology, plastic surgery.

Exclusion Criteria

• Subjects with a history of dementia or aphasia, as visual analog scale and confusion assessment will be unreliable.
• Patients with an epidural or spinal catheter block.
• Patients who do not speak English so that a language barrier is not confused with VAS scoring or confusion.
• Patients who are abusing alcohol defined by a high AUDIT score (>8) will be excluded.
• History of bipolar disorder or a psychotic disorder (such as a psychotic major depression, schizophrenia, schizoaffective disorder, or psychosis in Alzheimer's disease or other dementia).
• Patients with a documented allergy to ropivacaine or other sodium channel blockers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine	Ropivacaine HCL	Participants will have bilateral TAP catheters placed along with continuous infusion of ropivacaine.
Placebo	sodium chloride	Participants will have bilateral TAP catheters placed along with continuous infusion of placebo.

Primary Outcome Measures

Name	Time	Method
Pain Scores	Days 0-7 following the operation	Pain scores from the visual analog scale

Secondary Outcome Measures

Name	Time	Method
Amount of anesthetic	During the operation	MAC of inhalational agent, or total amount of IV anesthetic used during the operation
Amount of narcotic administered postoperatively	Days 0-7 postop	Amount of morphine equivalents per day measured after the operation

Trial Locations

Locations (1)

Denver Veterans Affairs Medical Center; 🇺🇸 Denver, Colorado, United States