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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2019-08-18

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.

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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.

Conditions

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Abdominal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.25%

Intervention Type DRUG

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

Triamcinolone

Intervention Type DRUG

Triamcinolone is a long-acting synthetic corticosteroid.

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.

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.25%

Intervention Type DRUG

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

Triamcinolone

Intervention Type DRUG

Triamcinolone is a long-acting synthetic corticosteroid.

Interventions

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Bupivacaine 0.25%

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

Intervention Type DRUG

Triamcinolone

Triamcinolone is a long-acting synthetic corticosteroid.

Intervention Type DRUG

Other Intervention Names

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Marcain Marcaine Sensorcaine Vivacaine KENALOG-40

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No