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Local Anesthetic

Sciatic Nerve Block for Amputation-Related Pain

Phase 4

Recruiting

Led By David Walega, MD,MSCI

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age greater than 18 years of age at day of enrollment

PLP/RLP in affected amputated limb > 4 on NRS26

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 120 hours

Awards & highlights

Study Summary

This trial is testing whether a sciatic nerve block can provide pain relief for people with chronic, refractory phantom limb pain or residual limb pain. The hypothesis is that the block will provide immediate, clinically meaningful pain reduction for patients.

Who is the study for?

This trial is for adults over 18 with chronic phantom or residual limb pain after lower extremity amputation, experiencing pain for more than 6 months despite trying various treatments. They must be willing to undergo a nerve block and not be using high doses of opioids or have had recent other interventional pain treatments.Check my eligibility

What is being tested?

The study tests if a sciatic nerve block on the limb opposite the amputated one can significantly reduce pain. Participants will receive an injection of either lidocaine (an anesthetic) or saline (a placebo) to see if there's at least a 50% improvement in their reported pain levels.See study design

What are the potential side effects?

Possible side effects from the lidocaine may include temporary numbness, tingling sensations, weakness in the injected leg, or allergic reactions. Saline injections are generally safe but could cause minor discomfort at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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I experience significant pain in my amputated limb.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~120 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comparison of the proportions of participants reporting ≥ 50% improvement in NRS pain score from baseline at 15 minutes in treatment and sham groups

Secondary outcome measures

Demographic factors associated with large improvement in NRS pain score

Mean and SD of average daily steps recorded at 24, 48, 72, 96, 120 hours post-saline and lidocaine injections (via Modus StepWatch™ or Evolution EvoWalk™)

Mean and SD of change in Groningen Activity Restriction Scale (GARS) score immediately post-injection and conclusion of washout (5 days) in saline and lidocaine groups

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment group 2% lidocaineExperimental Treatment1 Intervention

Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.

Group II: Sham preservative free salinePlacebo Group1 Intervention

Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,211 Total Patients Enrolled

David Walega, MD,MSCIPrincipal InvestigatorNorthwestern University

Media Library

2% Lidocaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05046639 — Phase 4

Amputation Research Study Groups: Treatment group 2% lidocaine, Sham preservative free saline

Amputation Clinical Trial 2023: 2% Lidocaine Highlights & Side Effects. Trial Name: NCT05046639 — Phase 4

2% Lidocaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05046639 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participant count for this medical experiment?

"Affirmative. Clinicaltrials.gov records suggest that this medical trial, initially posted on September 1st 2021, is actively seeking participants. 20 patients are expected to be enrolled across a single clinical site."

Answered by AI

What earlier research has been conducted related to 10 mL 2% lidocaine?

"As of now, 118 clinical trials for 10 mL 2% lidocaine are currently active with 31 in the last stage. Although Calgary holds most of these studies, there are 1,094 other sites conducting experimental research on this medication."

Answered by AI

To what purpose is 10 mL 2% lidocaine most commonly administered?

"10 mL of 2% lidocaine is a commonly used treatment for cervical syndrome and can be employed to help manage the symptoms associated with minor burns, transplantation, and osteoporosis."

Answered by AI

Is recruitment still open for this medical research project?

"Absolutely, the details featured on clinicaltrials.gov demonstrate that this experiment is actively recruiting volunteers. It was first advertised on September 1st 2021 and its information has been revised up until November 30th 2021. The research requires 20 participants to be enrolled from a single centre."

Answered by AI

Does the FDA approve of 10 mL 2% lidocaine for therapeutic use?

"Leveraging the data gathered in Phase 4 trials, our team at Power assigned 10 mL of 2% lidocaine a safety ranking of 3. This medication has already been approved for use by medical professionals."

Answered by AI

Recent research and studies

Military MedicineJournal

Percutaneous Peripheral Nerve Stimulation for the Treatment of Chronic Pain Following Amputation

Cohen, Steven P, Christopher A Gilmore, Richard L Rauck, Denise D Lester, Robert J Trainer, Thomas Phan, Leonardo Kapural, James M North, Nathan D Crosby, and Joseph W Boggs. 2019. “Percutaneous Peripheral Nerve Stimulation for the Treatment of Chronic Pain Following Amputation”. Military Medicine. Oxford University Press (OUP). doi:10.1093/milmed/usz114.

Archives of Physical Medicine and RehabilitationJournal

Phantom Pain, Residual Limb Pain, and Back Pain in Amputees: Results of a National Survey

Ephraim, Patti L., Stephen T. Wegener, Ellen J. MacKenzie, Timothy R. Dillingham, and Liliana E. Pezzin. 2005. “Phantom Pain, Residual Limb Pain, and Back Pain in Amputees: Results of a National Survey”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/j.apmr.2005.03.031.

American Journal of Physical Medicine & RehabilitationJournal

Chronic Pain Associated with Upper-limb Loss

Hanley, Marisol A., Dawn M. Ehde, Mark Jensen, Joseph Czerniecki, Douglas G. Smith, and Lawrence R. Robinson. 2009. “Chronic Pain Associated with Upper-limb Loss”. American Journal of Physical Medicine & Rehabilitation. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/phm.0b013e3181b306ec.

Journal of Pain and Symptom ManagementJournal