Continuous Transversus Abdominis Plane Nerve Block for Postoperative Analgesia

This study has been terminated.
(lack of enrollment)
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00944151
First received: July 21, 2009
Last updated: May 19, 2014
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Incisional Pain
Procedure: TAP Catheter and Infusion of Study Solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Continuous Transversus Abdominis Plane Nerve Block for Postoperative Analgesia: A Randomized, Triple-Masked, Placebo-Controlled Study

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

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

Enrollment: 20
Study Start Date: July 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944151

Locations
United States, California
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Vanessa Loland, M.D. University of California, San Diego
  More Information

No publications provided

Responsible Party: Vanessa Loland/Principal Investigator, University of California, San Diego, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT00944151     History of Changes
Other Study ID Numbers: TAP Catheter
Study First Received: July 21, 2009
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
pain
UCSD
catheter
nerve block
hernia
post-surgery pain
abdominal pain
pelvic pain
Transversus abdominal plane
Hernia Repair
Transversus Abdominal Plane Block

ClinicalTrials.gov processed this record on July 29, 2014