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Acute Post-Amputation Pain Management After Combat-Related Lower Limb Injury
Sponsor: Kharkiv National Medical University
Summary
Acute post-amputation pain remains a significant clinical challenge in patients with combat-related lower limb injuries and may negatively affect early rehabilitation, mobility, and opioid consumption. Various regional analgesia techniques and cryoanalgesia have been proposed to improve pain control; however, evidence regarding their feasibility and clinical utility in military trauma populations remains limited. The aim of this pilot study is to assess the feasibility of conducting a future randomized controlled trial evaluating different approaches to acute post-amputation pain management in patients with combat-related lower limb injuries. This prospective non-randomized pilot study will enroll 36 adult patients undergoing lower limb amputation or reamputation following combat-related trauma. Participants will be allocated to one of three groups according to clinical indications and multidisciplinary team decision: continuous peripheral nerve blocks, preoperative cryoablation, or standard multimodal analgesia. The primary outcomes will assess study feasibility, including recruitment rate, study completion rate, protocol adherence, and completeness of data collection. Secondary outcomes will include pain intensity assessed using the Numeric Rating Scale (NRS), opioid consumption expressed as Morphine Milligram Equivalents (MME), early mobility assessed using the Basic Amputee Mobility Score (BAMS), time to first standing and ambulation, and treatment-related complications. Participants will be followed for 7 days after surgery, with an additional assessment at 1 month.
Official title: Optimization of Acute Post-Amputation Pain Management in Patients With Combat-Related Lower Limb Injuries
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2026-10-10
Completion Date
2027-02-28
Last Updated
2026-10-07
Healthy Volunteers
No
Interventions
Continuous Peripheral Nerve Blocks
Ultrasound-guided continuous peripheral nerve blocks consisting of a sciatic nerve catheter and a suprainguinal fascia iliaca compartment (SIFI) catheter. Analgesia is provided using 0.25% bupivacaine administered as intermittent boluses according to clinical need.
Peripheral Nerve Cryoablation
Ultrasound-guided preoperative cryoablation of peripheral nerves selected according to the level of lower limb amputation using the CRYO-S® Painless system.
Standard multimodal analgesia
Standard multimodal analgesia including acetaminophen, non-steroidal anti-inflammatory drugs, pregabalin, optional amitriptyline, and opioid analgesics as needed according to local clinical practice.
Locations (1)
Military Medical Clinical Center of the Western Region
Lviv, Lviv Oblast, Ukraine