Sciatic Block in Contralateral Limb Phantom and Residual Limb Pain

Northwestern University

Status and phase: Terminated; Phase 4

Conditions: Amputation; Pain

Treatments: Drug: 10 mL preservative free saline; Drug: 10 mL 2% lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05046639

STU00215101

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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1 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

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.

Treatment:

Drug: 10 mL 2% lidocaine

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

Placebo Comparator group

Description:

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.

Treatment:

Drug: 10 mL preservative free saline