Sciatic Block in Contralateral Limb Phantom and Residual Limb Pain

Phase 4

Terminated

• Conditions: Amputation; Pain
• Interventions: Drug: 10 mL 2% lidocaine; Drug: 10 mL preservative free saline

• Registration Number: NCT05046639
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-16
• Primary Completion: 2023-07-26
• Study Completion: 2023-07-26
• Results First Submitted: 2023-07-30
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-12
• Last Update Submitted: 2025-02-12
• Results First Posted: 2025-03-03
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• 1. Age greater than 18 years of age at day of enrollment
• 2. Lower extremity amputation performed more than 12 months before study enrollment
• 3. PLP/RLP in affected amputated limb > 4 on numeric rating scale 26 (NRS26)
• 4. 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)
• 5. Willingness to undergo image guided diagnostic nerve block

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Group 2% Lidocaine first, then Sham Preservative Free Saline	10 mL 2% lidocaine	Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine. Crossover: Image guided sciatic nerve anesthetic block of the contralateral limb with 10 mL preservative-free saline. Crossover treatment will occur 5 days after the first block.
Sham Preservative Free Saline first, then Treatment Group 2% Lidocaine	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: Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine. Crossover treatment will occur 5 days after the first block.

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting ≥ 50% Improvement in NRS Pain Score	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.

Trial Locations

Locations (2)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States