Lidocaine Injections for Abdominal Pain

Recruiting at 1 trial location

Overseen By Sophia Lichenstein-Hill, DNP

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Oregon Health and Science University

Disqualifiers: Visceral pain, Lidocaine allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 1 day

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether lidocaine injections, a type of local anesthetic, can reduce chronic abdominal wall pain. It targets individuals with localized abdominal wall pain and daily pain levels of 3 or higher on a 0-10 scale. Participants should have pain suspected to originate from the abdominal wall itself, not from internal organs. Those who often experience pain around a surgical scar or test positive for Carnett’s sign, which helps pinpoint abdominal wall pain, might find this trial suitable. As a Phase 4 trial, the research focuses on understanding how an already FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for abdominal wall injections with lidocaine?

Research has shown that lidocaine injections for belly pain are generally safe. Studies have found that these injections can sometimes cause minor side effects, such as pain or a change in skin color at the injection site. In rare cases, individuals have fainted after receiving the injection.

Lidocaine has been safely used by patients before and is already approved by the FDA for other uses, enhancing its safety profile. Many patients with long-term pain have found trigger point injections with lidocaine to be effective and easy to tolerate.

Overall, lidocaine injections are considered a safe option for treating abdominal wall pain. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using lidocaine injections for abdominal pain because this treatment directly targets the abdominal wall, offering potentially rapid relief for patients suspected of having abdominal wall pain. Unlike traditional pain management options, which often involve oral medications or systemic treatments, lidocaine injections provide localized pain relief by numbing the specific area of pain. This method minimizes systemic side effects and can be an effective alternative for those who do not respond well to standard therapies like NSAIDs or opioids.

What is the effectiveness track record for abdominal wall injections with lidocaine for abdominal pain?

Research has shown that lidocaine injections effectively treat long-lasting abdominal wall pain. In one study, 83–91% of patients felt better after receiving a lidocaine injection. Another study found that 95% of patients experienced complete pain relief following the treatment. Additionally, 89% of patients reported either full or partial improvement in their symptoms with these injections. This trial will evaluate the effectiveness of abdominal wall injections with lidocaine 2% for patients suspected of having abdominal wall pain. This evidence suggests that lidocaine injections can significantly reduce abdominal wall pain for many patients. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with chronic abdominal pain who have a positive Carnett's sign or pain near an incisional site, and suspect their pain is from the abdominal wall. They must be over 18, not pregnant, able to consent, and without severe allergies to lidocaine or bleeding disorders.

Inclusion Criteria

My abdominal pain is thought to come from the abdominal wall.

My average daily pain is 3 or more on a scale of 0 to 10.

I have pain near a surgery scar that worsens when I tense my stomach.

Exclusion Criteria

I have had injections for abdominal pain.

I have a hernia where it hurts in my abdomen.

Unwillingness or inability to provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Baseline assessment includes medical history review, survey administration, and Quantitative Sensory Testing

1 week

1 visit (in-person)

Treatment

Participants receive abdominal wall injections with lidocaine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in abdominal wall pain at 1 week, 4 weeks, and 12 weeks following the injection

12 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Abdominal wall injections with lidocaine 2%

Trial Overview The study tests if injecting lidocaine into the abdominal wall helps reduce chronic pain in patients. It's conducted at an outpatient clinic where participants receive these injections as part of their usual care.

How Is the Trial Designed?

Group I: Abdominal wall injections for abdominal wall pain Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4760149/

Chronic Abdominal Wall Pain: A Poorly Recognized Clinical ... The injection of lidocaine alone brought about improvement in 83–91% of patients. Long-term pain relief ensued after a single lidocaine injection in 20–30 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1028455909602321

Efficacy of Treating Abdominal Wall Pain by Local Injection Forty-five (32.1%) patients still had abdominal pain and required a second injection. A total of 133 (95%) patients showed complete pain resolution. After 3 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06121466?cond=Roussy-L%C3%A9vy%20syndrome&rank=9

Effect of Abdominal Wall Injections on Abdominal Pain This is a prospective cohort study of outpatient adults with chronic abdominal wall pain who receive abdominal wall injections with lidocaine at an academic ...

4. journals.lww.com journals.lww.com/md-journal/fulltext/2020/12040/sonography_guided_trigger_point_injections_in.67.aspx

Sonography-guided trigger point injections in abdominal... found that 89% of patients with abdominal wall pain showed either complete or incomplete symptom improvement with trigger point injections (TPI) ...

5. trialx.com trialx.com/clinical-trials/listings/308769/effect-of-abdominal-wall-injections-on-abdominal-pain/

Effect of Abdominal Wall Injections on Abdominal Pain 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, ...

6. aafp.org aafp.org/pubs/afp/issues/2018/1001/p429.html

Abdominal Wall Pain: Clinical Evaluation, Differential ... In trigger point injection, 5 to 10 mL of 1% to 2% lidocaine is injected deep into the fascia and muscle at the point of maximal tenderness (see ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8450469/

Addressing Abdominal Wall Pain - PMC We warn patients they may feel a “stick” or a “sting” sensation. Once the tip of the needle is at the point of maximal tenderness, inject 1 mL of the mixture.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7717795/

Sonography-guided trigger point injections in abdominal ... TPI with lidocaine can be an effective and safe treatment for patients with chronic AMPS. ... Long-term follow-up of trigger point injections for ...

9. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39713&ver=3

LCD - Trigger Point Injections (L39713) Injections were made into the point of maximal abdominal wall pain just beneath the anterior fascia of the rectus abdominis muscle. A visual analogue scale ...