Effect of Abdominal Wall Injections on Abdominal Pain

NCT ID: NCT06121466

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-12-31

Brief Summary

This is a prospective cohort study of outpatient adults with chronic abdominal wall pain receiving abdominal wall injections, as part of their usual care, with lidocaine. Subjects will be recruited at the outpatient gastroenterology clinic at OHSU.

Detailed Description

This is a prospective cohort study of outpatient adults with chronic abdominal wall pain who receive abdominal wall injections with lidocaine at an academic medical center. Thirty patients will be enrolled. A baseline assessment will include a medical history review and survey administration (Pain Catastrophizing Scale, Psychological Inflexibility in Pain Scale, Patient-Reported Outcomes Measurement Information System-29, Recurrent Abdominal Pain Intensity and Disability scale). Subjects will undergo Quantitative Sensory Testing to measure their pain tolerance and thresholds. The primary outcome to be measured is the change in abdominal wall pain at 1 week, 4 weeks and 12 weeks following the abdominal wall injection, with improvement defined as a 50% reduction in baseline pain score measured using an 11-point numeric scale. Data analysis will consist of basic summary statistics to describe the mean, median, and standard deviation for demographic variables and clinical measures. A one-sample t-test or Wilcoxon test will be used to compare differences in continuous values between time points. Chi-square tests will be used to compare differences in categorical variables. An alpha of 0.05 will be used for all statistical tests. Univariate and multivariate logistic regression will be used to assess for factors associated with pain reduction.

Conditions

Anterior Cutaneous Nerve Entrapment Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abdominal wall injections for abdominal wall pain

Patients with abdominal pain who are suspected of having abdominal wall pain.

Group Type: EXPERIMENTAL

Abdominal wall injections with lidocaine 2%

Intervention Type: DRUG

Injections will be administered for patient who are identified as having abdominal wall pain.

Interventions

Abdominal wall injections with lidocaine 2%

Injections will be administered for patient who are identified as having abdominal wall pain.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Localized abdominal wall pain
• Average daily pain (7-day recall) ≥ 3 on a scale of 0-10
• Suspected abdominal wall etiology for abdominal pain
• Positive Carnett's sign or pain near an incisional site
• 18 years of age or older

Exclusion Criteria

• Suspected visceral etiology for the abdominal pain
• Severe allergy to lidocaine
• Unwillingness or inability to provide informed consent
• Low probability of follow-up
• Abdominal wall hernia noted at the point of pain
• History of trigger point injections for abdominal pain
• Bleeding disorder
• Pregnancy, incarceration or decisionally impaired

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Sophia Lichenstein-Hill

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

OHSU

Portland, Oregon, United States

Site Status: RECRUITING

Oregon Health Sciences University

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sophia Lichenstein-Hill, DNP

Role: CONTACT

lichenst@ohsu.edu

5038801235

Facility Contacts

Sophia Lichenstein-Hill

Role: primary

lichenst@ohsu.edu

5034944373

Oregon HS University

Role: primary

lichenst@ohsu.edu

5034944373

Other Identifiers

STUDY00024914

Identifier Type: -

Identifier Source: org_study_id