Continuous Transversus Abdominis Plane Nerve Block for Postoperative Analgesia

NCT ID: NCT00944151

Last Updated: 2014-05-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-09-30

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.

Conditions

Incisional Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Single injection with Saline infused TAP catheter

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.

Group Type: PLACEBO_COMPARATOR

TAP Catheter and Infusion of Study Solution

Intervention Type: PROCEDURE

Subject will be randomized to one of two groups: Saline infused TAP catheter following surgery for 0-2 days or ropivacaine infused TAP catheter following surgery for 0-2 days. All patients will be given a single injection of ropivacaine prior to surgery. Research staff will follow all patients for two days following surgery or while they have TAP catheter in.

Single injection with Ropivicaine infused TAP catheter

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

Group Type: ACTIVE_COMPARATOR

TAP Catheter and Infusion of Study Solution

Intervention Type: PROCEDURE

Subject will be randomized to one of two groups: Saline infused TAP catheter following surgery for 0-2 days or ropivacaine infused TAP catheter following surgery for 0-2 days. All patients will be given a single injection of ropivacaine prior to surgery. Research staff will follow all patients for two days following surgery or while they have TAP catheter in.

Interventions

TAP Catheter and Infusion of Study Solution

Subject will be randomized to one of two groups: Saline infused TAP catheter following surgery for 0-2 days or ropivacaine infused TAP catheter following surgery for 0-2 days. All patients will be given a single injection of ropivacaine prior to surgery. Research staff will follow all patients for two days following surgery or while they have TAP catheter in.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

University of California, San Diego, Department of Anesthesiology

Principal Investigators

Vanessa Loland, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

UCSD Medical Center

San Diego, California, United States

Countries

United States

Other Identifiers

TAP Catheter

Identifier Type: -

Identifier Source: org_study_id