NCT05046639

Sciatic Block in Contralateral Limb Phantom and Residual Limb Pain

Sciatic Block in Contralateral Limb for Treatment of Refractory Phantom and Residual Limb Pain; a Triple-Blind Randomized Crossover Controlled Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pain
• Amputation

Interventions

Type	Name	Description
DRUG	10 mL 2% lidocaine	Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine. Crossover treatment 5 days later using image guided sciatic nerve anesthetic block of the contralateral limb with 10 mL preservative-free saline.
DRUG	10 mL preservative free saline	Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline. Crossover treatment 5 days later using Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-07-26
• Completion: 2023-07-26
• First posted: 2021-09-16
• Last updated: 2025-03-03
• Results posted: 2025-03-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study