Continuous Transversus Abdominis Plane Nerve Block for Postoperative Analgesia

Continuous Transversus Abdominis Plane Nerve Block for Postoperative Analgesia: A Randomized, Triple-Masked, Placebo-Controlled Study

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.

Study Overview

• Status: Terminated
• Conditions: Incisional Pain
• Intervention / Treatment: Procedure: TAP Catheter and Infusion of Study Solution

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • UCSD Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Procedure: 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.
Active Comparator: 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	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Vanessa Loland, M.D., University of California, San Diego

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: July 21, 2009
• First Submitted That Met QC Criteria: July 22, 2009
• First Posted (Estimate): July 23, 2009

Study Record Updates

• Last Update Posted (Estimate): May 20, 2014
• Last Update Submitted That Met QC Criteria: May 19, 2014
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: pain; hernia; nerve block; abdominal pain; catheter; UCSD; pelvic pain; Hernia Repair; Transversus Abdominal Plane Block; post-surgery pain; Transversus abdominal plane
• Other Study ID Numbers: TAP Catheter