A Study of Contralateral Limb Block

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-18

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This research is being done to determine if an anesthetic like Lidocaine, may be effective when injected around the sciatic nerve of the intact limb in patients with limb loss pain on the contralateral side.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sciatic Block in Contralateral Limb Phantom and Residual Limb Pain

NCT05046639

Pain Amputation

TERMINATED PHASE4

Continuous Sciatic Nerve Block vs Epidural Analgesia in Lower Limb Amputation for Postoperative Pain

NCT05608733

Phantom Limb Pain Pain, Chronic

UNKNOWN PHASE3

A Novel Concept for Continuous Peripheral Nerve Block - Sciatic Nerve

NCT02456597

Pain

COMPLETED NA

Pre-emptive Sciatic Bloc to Prevent Lower Limb Phantom Pain

NCT00528463

Phantom Limb Pain

COMPLETED PHASE4

Characteristics of Popliteal Sciatic Nerve Block in Patients With and Without Diabetic Neuropathy

NCT02076945

Diabetic Neuropathy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Limb Pain, Phantom

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lidocaine Group

Subjects will receive a lidocaine injection in the back of their residual limb.

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

2 teaspoons of 2% lidocaine injection

Sham Group

Subjects will receive a placebo injection in the back of their residual limb.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lidocaine

2 teaspoons of 2% lidocaine injection

Intervention Type DRUG

Placebo

Saline injection

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Lower extremity amputation performed more than 12 months before study enrollment
* PLP/RLP in affected amputated limb \> 4 on NRS26
* Pain duration of more than 6 months despite a trial of conservative therapies for at least 2 months, including oral medications, topical medicines, physical therapy, and physical modalities (i.e., heat, cold, transcutaneous electrical nerve stimulation, phonophoresis)
* Willingness to undergo image guided diagnostic nerve block

Exclusion Criteria

* Refusal / inability to participate or provide consent
* Contraindications to diagnostic nerve block
* Non-neurogenic source of PLP/RLP
* Current opioid use \> 50 morphine milligram equivalents per day
* Any interventional pain treatment in the residual limb within the last 30 days
* Severe uncontrolled medical condition (i.e., hypertensive crisis, decompensated hypothyroidism)
* Use of investigational pain drug within past 30 days or other concurrent clinical trial enrollment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No