Sciatic Block in Contralateral Limb Phantom and Residual Limb Pain

NCT ID: NCT05046639

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2023-07-26

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.

Conditions

Pain; Amputation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment Group 2% Lidocaine first, then Sham Preservative Free Saline

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.

Group Type: EXPERIMENTAL

10 mL 2% lidocaine

Intervention Type: DRUG

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.

Sham Preservative Free Saline first, then Treatment Group 2% Lidocaine

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.

Group Type: PLACEBO_COMPARATOR

10 mL preservative free saline

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Hogue, MD

Role: STUDY_DIRECTOR

Northwestern University

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

References

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Reference Type: RESULT

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STU00215101

Identifier Type: -

Identifier Source: org_study_id