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OpenTrials
Completed

NCT Number: NCT01906944

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bupivacaine 0.25%

Drug

Bupivacaine is a local anaesthetic drug belonging to the amino amide group.

Other names: Marcain, Marcaine, Sensorcaine, Vivacaine

Triamcinolone

Drug

Triamcinolone is a long-acting synthetic corticosteroid.

Other names: KENALOG-40

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Jul 24, 2013
Registry last updated
May 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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