Clinical trial NCT00944151: Continuous Transversus Abdominis Plane Nerve Block for Postoperative Analgesia
Official title: Continuous Transversus Abdominis Plane Nerve Block for Postoperative Analgesia: A Randomized, Triple-Masked, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Incisional Pain
Keywords: pain
UCSD
catheter
nerve block
hernia
post-surgery pain
abdominal pain
pelvic pain
Transversus abdominal plane
Hernia Repair
Transversus Abdominal Plane Block
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2009-07-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 1 day
Secondary outcomes:
measure: Pain with movement on second day following surgery, as measured by 0-10 scale (where 0=no pain and 10=worst imaginable pain).
timeFrame: 2 days
measure: Total opioid consumption per day following surgery as measured by the number of opioid pills consumed per day.
timeFrame: Day 1 and 2 following surgery
measure: Sleep disturbances, measured on days 1 and 2 following surgery, as asked by research staff during follow-up phone calls.
timeFrame: Days 1 and 2 following surgery
measure: Patient satisfaction of pain control as measured on a 0-10 scale where 0=very unsatisfied and 10=very satisfied with pain control
timeFrame: Day 2 following surgery
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Vanessa Loland, M.D.
role: PRINCIPAL_INVESTIGATOR
References: