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NCT05046639

Sciatic Block in Contralateral Limb Phantom and Residual Limb Pain

Terminated Phase 4 Results posted Last updated 3 March 2025
What this trial tests

Phase 4 trial testing 10 mL 2% lidocaine in Pain in 1 participant. Terminated before completion.

Timeline
1 September 2021
Primary endpoint
26 July 2023
26 July 2023

Quick facts

Lead sponsorNorthwestern University
PhasePhase 4
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingquadruple
Primary purposetreatment
Enrollment1
Start date1 September 2021
Primary completion26 July 2023
Estimated completion26 July 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Northwestern University

Who can join

18 and older, any sex, with Pain or Amputation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Reporting ≥ 50% Improvement in NRS Pain Score Primary · 15 minutes after treatment

Proportions of Participants Reporting ≥ 50% Improvement in NRS pain score on a scale of 0 (no pain) to 10 (worst pain imaginable) from baseline at 15 minutes in treatment and sham groups.

GroupValue95% CI
Treatment Group 2% Lidocaine1
Sham Preservative Free Saline1

Sponsor's own description

Participants with chronic, refractory phantom limb pain (PLP) or residual limb pain (RLP) for more than 6 months will be enrolled in this clinical trial. Aim: Define the attributable pain relief and functional improvement in participants with PLP/RLP after contralateral limb sciatic nerve block. Also, contribute to the basic science understanding of the crossed-withdraw reflex by demonstrating a known animal model phenomenon in human participants. Hypothesis: Contralateral limb sciatic nerve anesthetic block with 2% lidocaine provides immediate clinically meaningful pain reduction, defined as the proportion of patients with at least 50% improvement in numeric rating scale (NRS) pain score in PLP/RLP when compared to sham.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Pain

Currently open trials in the same condition.

Other Northwestern University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05046639.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing