Acute Post-Amputation Pain Management After Combat-Related Lower Limb Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorKharkiv National Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 60 years.
Planned or completed lower limb amputation or reamputation due to combat-related trauma.
Enrollment before amputation/reamputation or within 24 hours after surgery.
Planned or completed lower limb amputation or reamputation requiring postoperative analgesic treatment.
Disqualifiers
Refusal to participate in the study.
Inability to provide informed consent.
Allergy or hypersensitivity to amide local anesthetics.
Infection at the planned site of regional anesthesia or catheter placement.
Trial design
Design model
Parallel
Treatments tested in this trial
Continuous Peripheral Nerve Blocks
Procedure/SurgeryUltrasound-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
Procedure/SurgeryUltrasound-guided preoperative cryoablation of peripheral nerves selected according to the level of lower limb amputation using the CRYO-S® Painless system.
Standard multimodal analgesia
DrugStandard multimodal analgesia including acetaminophen, non-steroidal anti-inflammatory drugs, pregabalin, optional amitriptyline, and opioid analgesics as needed according to local clinical practice.
Treatment groups
36 Participants
are divided into 3 treatment groupsGroup A: Continuous Peripheral Nerve BlocksExperimental treatment 1 intervention
Group B: Preoperative CryoablationExperimental treatment 1 intervention
Group C: Standard Multimodal AnalgesiaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment Rate
Proportion of eligible patients successfully enrolled in the study.
Time frame
4 months2
Study Completion Rate
Proportion of enrolled participants who complete the 7-day follow-up and 1-month assessment.
Time frame
1 month3
Completeness of Data Collection
Proportion of completed data points for pain, mobility, opioid consumption, and safety assessments.
Time frame
1 monthSecondary outcomes
1
Pain Intensity at Rest (NRS)
Pain Intensity at Rest measured using the Numeric Rating Scale (NRS). Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity.
Time frame
Baseline, 24 hours, 48 hours, 72 hours, Day 7, Month 12
Pain Intensity During Movement (NRS)
Pain Intensity During Movement measured using the Numeric Rating Scale (NRS). Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity.
Time frame
Baseline, 24 hours, 48 hours, 72 hours, Day 7, Month 13
Early Mobility (BAMS)
Early mobility will be assessed using the Basic Amputee Mobility Score (BAMS). BAMS is a clinician-administered functional mobility scale that evaluates basic mobility following lower limb amputation. The total score ranges from 0 to 8, with higher scores indicating better mobility performance.
Time frame
24 hours, 72 hours, Day 7, Month 14
Opioid Consumption (MME)
Total opioid consumption expressed as Morphine Milligram Equivalents (MME) during each assessment interval. Higher values indicate greater opioid consumption.
Time frame
24 hours, 48 hours, 72 hours, Day 7Sponsors and contacts
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Source ClinicalTrials.gov
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