Continuous Transversus Abdominis Plane Nerve Block for Postoperative Analgesia

Phase 4

Terminated

• Conditions: Incisional Pain
• Interventions: Procedure: TAP Catheter and Infusion of Study Solution

• Registration Number: NCT00944151
• Lead Sponsor: University of California, San Diego

Brief Summary

Research study to determine if putting local anesthetic through one or two tiny tubes next to the nerves that go to the area the patients are having surgery on (abdomen or pelvis), will improve pain control following surgery. This study will also help determine if patients require fewer pain pills, experience fewer sleep disturbances, and are more satisfied with their postoperative pain control.

Detailed Description

Specific Aim: To determine if adding a continuous Transversus Abdominis Plane nerve block to a single-injection nerve block results in improved postoperative pain control.

Hypothesis 1: Adding a continuous Transversus Abdominis Plane nerve block to a single-injection nerve block results in lower average pain scores during movement the day following surgery.

Specific Aim2: To determine if adding a continuous Transversus Abdominis Plane nerve block to a single-injection nerve block results in decreased average pain scores, opioid use, sleep disturbances, and improved patient satisfaction.

Hypothesis 2: Adding a continuous Transversus Abdominis Plane nerve block to a single-injection nerve block results in decreased average pain scores, oral opioid consumption, sleep disturbances, and improved patient satisfaction the day following surgery.

Study Timeline

• Status Verified: 2009-07
• Study Start: 2009-07
• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2014-05-19
• Last Update Posted: 2014-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• undergoing ambulatory inguinal and/or abdominal surgery amenable to a Transversus Abdominis Plane nerve block (unilateral or bilateral).
• expected postoperative pain to be at least moderate in severity the day following surgery
• age 18 years or older
• desires a regional anesthetic for postoperative analgesia
• is able to understand the possible perineural infusion-related complications, study protocol, and catheter/pump care
• has a caretaker through the first night after surgery
• has an ASA Physical Status Classification of 1-3

Exclusion Criteria

• any contraindication for a continuous Transversus Abdominis Plane nerve block
• any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
• current chronic opioid or tramadol use
• history of alcohol or opioid abuse
• know allergy or other contraindication to the study medication
• pregnancy
• known hepatic or renal insufficiency/disease
• peripheral neuropathy of the surgical site
• morbid obesity
• inability to communicate with the investigators and hospital staff
• incarceration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single injection with Saline infused TAP catheter	TAP Catheter and Infusion of Study Solution	Prior to surgery patient will receive single injection of 0.5% ropivacaine and a TAP catheter. Following surgery patient will be given normal saline in infusion pump, attached to catheter.
Single injection with Ropivicaine infused TAP catheter	TAP Catheter and Infusion of Study Solution	Prior to surgery patient will receive single injection of 0.5% ropivacaine and a TAP catheter. Following surgery patient will be given 0.2% ropivicaine in infusion pump, attached to catheter

Primary Outcome Measures

Name	Time	Method
The primary outcome measurement will be the average pain with movement on postoperative day 1 as measured by 0-10 scale, where 0=no pain and 10=worst imaginable pain.	1 day

Secondary Outcome Measures

Name	Time	Method
Pain with movement on second day following surgery, as measured by 0-10 scale (where 0=no pain and 10=worst imaginable pain).	2 days
Total opioid consumption per day following surgery as measured by the number of opioid pills consumed per day.	Day 1 and 2 following surgery
Sleep disturbances, measured on days 1 and 2 following surgery, as asked by research staff during follow-up phone calls.	Days 1 and 2 following surgery
Patient satisfaction of pain control as measured on a 0-10 scale where 0=very unsatisfied and 10=very satisfied with pain control	Day 2 following surgery

Trial Locations

Locations (1)

UCSD Medical Center; 🇺🇸 San Diego, California, United States