Continuous Transversus Abdominis Plane Nerve Block for Postoperative Analgesia

University of California San Diego

Status and phase: Terminated; Phase 4

Conditions: Incisional Pain

Treatments: Procedure: TAP Catheter and Infusion of Study Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT00944151

TAP Catheter

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

20 participants in 2 patient groups, including a placebo group

Single injection with Saline infused TAP catheter

Placebo Comparator group

Description:

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.

Treatment:

Procedure: TAP Catheter and Infusion of Study Solution

Single injection with Ropivicaine infused TAP catheter

Active Comparator group

Description:

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

Treatment:

Procedure: TAP Catheter and Infusion of Study Solution