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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Abdominal Pain

Intervention / Treatment
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* Drug: Bupivacaine 0.25%
* Drug: Triamcinolone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trigger point injection<br>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%<br>* Bupivacaine is a local anaesthetic drug belonging to the amino amide group.<br>* Other names: Vivacaine;Drug: Triamcinolone<br>* Triamcinolone is a long-acting synthetic corticosteroid.<br>* Other names: KENALOG-40;|
| Active Comparator: Transversus abdominis plane block<br>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%<br>* Bupivacaine is a local anaesthetic drug belonging to the amino amide group.<br>* Other names: Vivacaine;Drug: Triamcinolone<br>* Triamcinolone is a long-acting synthetic corticosteroid.<br>* Other names: KENALOG-40;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trigger point injection, transversus abdominis plane, abdominal wall pain