Effect of Abdominal Wall Injections on Abdominal Pain

DRUG

Abdominal wall injections with lidocaine 2%

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

1) To measure the change in abdominal wall pain 1-week, 1-month and 3-months following abdominal wall injections, with improvement defined as a 50% reduction in baseline pain score measured using an 11-point numeric scale.

Time frame: 12 weeks

Improvement is defined as a 50% reduction in baseline pain score measured using an 11-point numeric scale where 0 is no pain and 10 is the worst pain the patient has every felt.

2) To determine patient characteristics, such as pain catastrophizing, associated with a response to abdominal wall injection

Time frame: 12 weeks

This will be measured by the following: Pain Catastrophizing Scale (PCS): Each question is rated on a scale of 0 to 4, where 0 is no catastrophizing, and 4 is significant catastrophizing.

2) To determine patient characteristics, such as patient reported functional status, pain status, and global estimate status; associated with a response to abdominal wall injection

Time frame: 12 weeks

This will be measured by the following: Routine Assessment of Patient Index Data (RAPID) Questionnaire: Assessing patient-reported measures of function, pain, and patient global estimate status. First set of items are rated on a 4-point scale, ranging from 0 to 3, where higher scores indicate lower functioning. Second set of items are rated on a scale from 0 to 10 where the higher the number the more pain the person is experiencing. The third set is rated on a scale from 0 to 10 where 10 is the poorest overall status.

2) To determine patient characteristics, within seven health domains, associated with a response to abdominal wall injection

Time frame: 12 weeks

This will be measured by the following: Patient-Reported Outcomes Measurement Information System-29 Scale: Assessing pain intensity using a single 0-10 numeric rating (0 is no pain, 10 is the worst pain ever felt) item and seven health domains.

2) To determine patient characteristics, such as psychological inflexibility, associated with a response to abdominal wall injection

Time frame: 12 weeks

Psychological Inflexibility in Pain Scale: Items are rated on a 7-point scale, ranging from 1 to 7, where higher scores indicate greater levels of psychological inflexibility.

3) To determine the rate of adverse events associated with abdominal wall injection.

Time frame: 12 weeks

Adverse events associated with abdominal wall injections include pain or discoloration at the injection site, a syncopal episode after the injection, allergic reaction to lidocaine or alcohol swab/chloroprep. There is a rare risk for seizures and injury to a muscle.

4) To measure pain thresholds with use of heat, using quantitative sensory testing (QST) in patients receiving abdominal wall injections.

Time frame: 12 weeks

This will be measured by the following: Heat Pain Threshold and Pain Tolerance :. This task involves applying a series of heat sensations using a heat thermode (TSA-II Air, Medoc) to the subject's dominant inner forearm.

4) To measure pain thresholds with use of temporal summation, using quantitative sensory testing (QST) in patients receiving abdominal wall injections.

Time frame: 12 weeks

This will be measured by the following: Temporal summation. For assessment of temporal summation (TS), punctate mechanical stimuli will be delivered to the dorsal surface of the dominant hand using a 300-gm nylon monofilament developed by the German Research Network on Neuropathic Pain.

4) To measure pain thresholds with use of pressure thresholds, using quantitative sensory testing (QST) in patients receiving abdominal wall injections.

Time frame: 12 weeks

This will be measured by the following: Pressure pain threshold. Pressure pain threshold (PPTh) will be assessed via an algometer using pressure pain stimuli delivered to dorsal forearm (distal stimuli) and the trapezius (order counterbalanced).

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.