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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Delirium; Anesthesia, Local
• Intervention / Treatment: Drug: Ropivacaine HCL; Drug: sodium chloride

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Douglas Overbey, MD; Phone Number: 573-225-7728; Email: douglas.overbey@ucdenver.edu
• Study Contact Backup: Name: Thomas Robinson, MD; Phone Number: 303-399-8020 Ext. 2952; Email: thomas.robinson@ucdenver.edu

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80221
      • Recruiting
      • Denver Veterans Affairs Medical Center
      • Contact: Douglas Overbey, MD; Phone Number: 573-225-7728; Email: douglas.overbey@ucdenver.edu
      • Contact: Thomas Robinson, MD; Phone Number: 2952 303-399-8020; Email: thomas.robinson@ucdenver.edu
      • Principal Investigator: Thomas N Robinson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ropivacaine; Participants will have bilateral TAP catheters placed along with continuous infusion of ropivacaine.	Drug: Ropivacaine HCL; Ropivacaine injected after placement of catheters, then infused during the operation
Placebo Comparator: Placebo; Participants will have bilateral TAP catheters placed along with continuous infusion of placebo.	Drug: sodium chloride; Placebo; Other Names: saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	Pain scores from the visual analog scale	Days 0-7 following the operation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2018
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: May 10, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 16-1078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No