NCT01906944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2019

Completed
Last Updated

May 14, 2020

Status Verified

May 1, 2020

Enrollment Period

7.6 years

First QC Date

July 1, 2013

Last Update Submit

May 12, 2020

Conditions

Abdominal Pain

Keywords

trigger point injectiontransversus abdominis planeabdominal wall pain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Trigger point injection

ACTIVE COMPARATOR

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%Drug: Triamcinolone

Transversus abdominis plane block

ACTIVE COMPARATOR

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%Drug: Triamcinolone

Interventions

Bupivacaine 0.25%DRUG

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

Also known as: Marcain, Marcaine, Sensorcaine, Vivacaine
Transversus abdominis plane blockTrigger point injection
TriamcinoloneDRUG

Triamcinolone is a long-acting synthetic corticosteroid.

Also known as: KENALOG-40
Transversus abdominis plane blockTrigger point injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Moeschler SM, Pollard EM, Pingree MJ, Pittelkow TP, Bendel MA, Mauck WD, Watson JC, Eldrige JS, Loftus CG, Hooten WM. Ultrasound-guided transversus abdominis plane block vs trigger point injections for chronic abdominal wall pain: a randomized clinical trial. Pain. 2021 Jun 1;162(6):1800-1805. doi: 10.1097/j.pain.0000000000002181.

    PMID: 33433147DERIVED

Related Links

MeSH Terms

Conditions

Abdominal Pain

Interventions

BupivacaineTriamcinolone

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Susan Moeschler, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

July 1, 2013

First Posted

July 24, 2013

Study Start

January 1, 2012

Primary Completion

August 18, 2019

Study Completion

August 18, 2019

Last Updated

May 14, 2020

Record last verified: 2020-05

Locations

US(1)