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Trial record 4 of 9 for:    TPI | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Susan M. Moeschler, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01906944
First received: July 1, 2013
Last updated: November 8, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Abdominal Pain
Drug: Bupivacaine 0.25%
Drug: Triamcinolone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultrasound Guided Transversus Abdominis Plane Block vs. Trigger Point Injection for Abdominal Wall Pain: A Randomized Comparative Trial

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Marcain
  • Marcaine
  • Sensorcaine
  • Vivacaine
Drug: Triamcinolone
Triamcinolone is a long-acting synthetic corticosteroid.
Other Name: 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:
  • Marcain
  • Marcaine
  • Sensorcaine
  • Vivacaine
Drug: Triamcinolone
Triamcinolone is a long-acting synthetic corticosteroid.
Other Name: KENALOG-40

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01906944

Contacts
Contact: Brenda K Anderson, RN anderson.brenda@mayo.edu
Contact: Susan M Moeschler, MD moeschler.susan@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Brenda K Anderson, RN       anderson.brenda@mayo.edu   
Principal Investigator: Susan M Moeschler, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Susan Moeschler, MD Mayo Clinic
  More Information

Responsible Party: Susan M. Moeschler, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01906944     History of Changes
Other Study ID Numbers: 11-004223
Study First Received: July 1, 2013
Last Updated: November 8, 2016

Keywords provided by Mayo Clinic:
trigger point injection
transversus abdominis plane
abdominal wall pain

Additional relevant MeSH terms:
Abdominal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Bupivacaine
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 28, 2017