ClinicalTrials.gov
ClinicalTrials.gov Menu

Continuous Transversus Abdominis Plane Nerve Block for Postoperative Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00944151
Recruitment Status : Terminated (lack of enrollment)
First Posted : July 23, 2009
Last Update Posted : May 20, 2014
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Incisional Pain Procedure: TAP Catheter and Infusion of Study Solution Phase 4

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  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Continuous Transversus Abdominis Plane Nerve Block for Postoperative Analgesia: A Randomized, Triple-Masked, Placebo-Controlled Study
Study Start Date : July 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: July 23, 2009    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: July 2009

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

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents