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

May 12, 2020 updated by: Susan M. Moeschler, M.D., Mayo Clinic

Ultrasound Guided Transversus Abdominis Plane Block vs. Trigger Point Injection for Abdominal Wall Pain: A Randomized Comparative Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Trigger point injection
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.
Drug: Bupivacaine 0.25%
Bupivacaine is a local anaesthetic drug belonging to the amino amide group.
Other Names:
  • Marcaine
  • Sensorcaine
  • Marcain
  • Vivacaine
Drug: Triamcinolone
Triamcinolone is a long-acting synthetic corticosteroid.
Other Names:
  • KENALOG-40
ACTIVE_COMPARATOR: Transversus abdominis plane block
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.
Drug: Bupivacaine 0.25%
Bupivacaine is a local anaesthetic drug belonging to the amino amide group.
Other Names:
  • Marcaine
  • Sensorcaine
  • Marcain
  • Vivacaine
Drug: Triamcinolone
Triamcinolone is a long-acting synthetic corticosteroid.
Other Names:
  • KENALOG-40

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean Numerical Pain Score
Time Frame: baseline to 6 months
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.
baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Susan Moeschler, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

August 18, 2019

Study Completion (ACTUAL)

August 18, 2019

Study Registration Dates

First Submitted

July 1, 2013

First Submitted That Met QC Criteria

July 18, 2013

First Posted (ESTIMATE)

July 24, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 14, 2020

Last Update Submitted That Met QC Criteria

May 12, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-004223

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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