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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01906944

Collaborator

(none)

Enrollment

Location

Arms

91.5

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Abdominal Pain	Drug: Bupivacaine 0.25% Drug: Triamcinolone	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Aug 18, 2019

Actual Study Completion Date :

Aug 18, 2019

Arms and Interventions

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: Marcain Marcaine Sensorcaine 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: Marcain Marcaine Sensorcaine Vivacaine Drug: Triamcinolone Triamcinolone is a long-acting synthetic corticosteroid. Other Names: KENALOG-40

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:

Marcain

Marcaine

Sensorcaine

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:

Marcain

Marcaine

Sensorcaine

Vivacaine

Drug: Triamcinolone

Triamcinolone is a long-acting synthetic corticosteroid.

Other Names:

KENALOG-40

Outcome Measures

Primary Outcome Measures

Change in Mean Numerical Pain Score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.