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Ultrasound Guided Transversus Abdominis Plane (TAP) vs. Trigger Point Injection (TPI) for Abdominal Wall Pain

Primary Purpose

Abdominal Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine 0.25%
Triamcinolone
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Pain focused on measuring trigger point injection, transversus abdominis plane, abdominal wall pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Only patients referred to Pain Clinic for a trigger point injection.

  • Non-cancer pain greater than 3 months duration.
  • Unilateral abdominal pain.
  • Positive Carnett's sign (A test in which acute abdominal pain remains unchanged or increases when the muscles of the abdominal wall are tensed.)
  • An identifiable abdominal trigger point.

Exclusion Criteria:

  • History of chronic psychotic disorder.
  • History of dementing illness.
  • Active abdominal visceral disease as a known contributor of the pain.
  • Abdominal surgery in the past 6 months.
  • More than one trigger point.
  • Abdominal wall hernias.
  • BMI>40.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Trigger point injection

Transversus abdominis plane block

Arm Description

Trigger point injection under ultrasound guidance into the fascial layer above the external oblique or rectus muscle, whichever corresponds to patient's identifiable trigger point. The injectate will include 5 ml of bupivacaine 0.25% mixed with triamcinolone 20 mg.

Injection into transversus abdominis plane layer under ultrasound guidance on the affected side along the mid-axillary line. The injectate will include 10 ml of bupivacaine 0.25% mixed with triamcinolone 20 mg.

Outcomes

Primary Outcome Measures

Change in Mean Numerical Pain Score
Pain intensity will be assessed using the 11-point Numerical Pain Score questionnaire where "0" denotes no pain and "10" signifies the most intense pain imaginable.

Secondary Outcome Measures

Full Information

First Posted
July 1, 2013
Last Updated
May 12, 2020
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01906944
Brief Title
Ultrasound Guided Transversus Abdominis Plane (TAP) vs. Trigger Point Injection (TPI) for Abdominal Wall Pain
Official Title
Ultrasound Guided Transversus Abdominis Plane Block vs. Trigger Point Injection for Abdominal Wall Pain: A Randomized Comparative Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
August 18, 2019 (Actual)
Study Completion Date
August 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with chronic abdominal pain- with a component of abdominal wall pain- are often treated with trigger point injections. This study will help to determine if a block within the transversus abdominis plane (TAP) will provide superior analgesic benefit to a trigger point injection as therapy for these patients.
Detailed Description
Only patients referred to the Pain Clinic for abdominal trigger point injections for abdominal wall pain will be considered for study recruitment. Following informed consent, patients will complete a baseline questionnaire in the Pain Clinic which gathers basic demographic data, pain scores and functional scores. Patients will be randomized to receive either a TAP injection or a TPI. Because the TAP injection involves a larger area to be anesthetized, a larger volume of medication will be used. Thirty minutes after the injection, a sensory exam will be performed on the patient to determine the level of block. At one week, one month, three months and six months after the injection, a staff member will telephone the patient to assess how they are doing. The call will take approximately 10 minutes and will consist of relaying a pain score as well as daily functioning and sleep questions. Subjects are responsible for all clinical costs associated with the injection. There is no remuneration offered for study participation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain
Keywords
trigger point injection, transversus abdominis plane, abdominal wall pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trigger point injection
Arm Type
Active Comparator
Arm Description
Trigger point injection under ultrasound guidance into the fascial layer above the external oblique or rectus muscle, whichever corresponds to patient's identifiable trigger point. The injectate will include 5 ml of bupivacaine 0.25% mixed with triamcinolone 20 mg.
Arm Title
Transversus abdominis plane block
Arm Type
Active Comparator
Arm Description
Injection into transversus abdominis plane layer under ultrasound guidance on the affected side along the mid-axillary line. The injectate will include 10 ml of bupivacaine 0.25% mixed with triamcinolone 20 mg.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25%
Other Intervention Name(s)
Marcain, Marcaine, Sensorcaine, Vivacaine
Intervention Description
Bupivacaine is a local anaesthetic drug belonging to the amino amide group.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Other Intervention Name(s)
KENALOG-40
Intervention Description
Triamcinolone is a long-acting synthetic corticosteroid.
Primary Outcome Measure Information:
Title
Change in Mean Numerical Pain Score
Description
Pain intensity will be assessed using the 11-point Numerical Pain Score questionnaire where "0" denotes no pain and "10" signifies the most intense pain imaginable.
Time Frame
baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Only patients referred to Pain Clinic for a trigger point injection. Non-cancer pain greater than 3 months duration. Unilateral abdominal pain. Positive Carnett's sign (A test in which acute abdominal pain remains unchanged or increases when the muscles of the abdominal wall are tensed.) An identifiable abdominal trigger point. Exclusion Criteria: History of chronic psychotic disorder. History of dementing illness. Active abdominal visceral disease as a known contributor of the pain. Abdominal surgery in the past 6 months. More than one trigger point. Abdominal wall hernias. BMI>40.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Moeschler, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33433147
Citation
Moeschler SM, Pollard EM, Pingree MJ, Pittelkow TP, Bendel MA, Mauck WD, Watson JC, Eldrige JS, Loftus CG, Hooten WM. Ultrasound-guided transversus abdominis plane block vs trigger point injections for chronic abdominal wall pain: a randomized clinical trial. Pain. 2021 Jun 1;162(6):1800-1805. doi: 10.1097/j.pain.0000000000002181.
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Ultrasound Guided Transversus Abdominis Plane (TAP) vs. Trigger Point Injection (TPI) for Abdominal Wall Pain

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