Effect of Abdominal Wall Injections on Abdominal Pain

Oregon Health & Science University (OHSU)

Status and phase: Enrolling; Phase 4

Conditions: Anterior Cutaneous Nerve Entrapment Syndrome

Treatments: Drug: Abdominal wall injections with lidocaine 2%

Study type: Interventional

Funder types: Other

Identifiers

NCT06121466

STUDY00024914

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Abdominal wall injections for abdominal wall pain

Experimental group

Description:

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

Treatment:

Drug: Abdominal wall injections with lidocaine 2%