Postamputation PainAPAPMACRLLINCT07863921
Acute Post-Amputation Pain Management After Combat-Related Lower Limb Injury
A study testing Continuous Peripheral Nerve Blocks, Peripheral Nerve Cryoablation and Standard multimodal analgesia in people with Postamputation Pain and Lower Limb Amputation, run by Kharkiv National Medical University at 1 site in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postamputation Pain, Lower Limb Amputation, Combat Trauma
- What is being tested?
- Continuous Peripheral Nerve Blocks, Peripheral Nerve Cryoablation and Standard multimodal analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUkraine
- Study dates
- 10 Oct 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- Ability to provide written informed consent.
Who cannot join
- 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.
- Severe cognitive impairment or psychiatric disorders preventing reliable pain assessment.
- Decompensated cardiovascular, respiratory, renal, hepatic, or endocrine disease that may affect study outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ukraine1 site
Military Medical Clinical Center of the Western Region
Lviv, Lviv Oblast, 79010
Andrii Halushko, +380953622699, andriiihalushko@gmail.com
About this study
Official title: Optimization of Acute Post-Amputation Pain Management in Patients With Combat-Related Lower Limb Injuries
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.
Read more
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.
Read the detailed description
Combat-related lower limb injuries remain a major cause of limb loss among military personnel. Acute post-amputation pain is highly prevalent following amputation or reamputation procedures and represents a significant barrier to recovery. Inadequate pain control may lead to increased opioid consumption, delayed mobilization, prolonged hospitalization, and impaired participation in rehabilitation programs.
Multimodal analgesia remains the standard approach to postoperative pain management; however, opioid requirements often remain substantial despite the use of non-opioid analgesics and adjuvant medications. Regional anesthesia techniques, including continuous peripheral nerve blocks, have demonstrated the potential to improve pain control while reducing opioid exposure. Similarly, cryoablation of peripheral nerves has emerged as a promising technique for prolonged analgesia through reversible interruption of nerve conduction.
Despite growing interest in these interventions, evidence regarding their feasibility, safety, and clinical utility in patients with combat-related amputations remains limited. Furthermore, direct comparisons between continuous peripheral nerve blocks, cryoablation, and standard multimodal analgesia in military trauma populations are scarce.
The present pilot study is designed to evaluate the feasibility of conducting a future randomized controlled trial investigating different approaches to acute post-amputation pain management. Feasibility outcomes will include recruitment rate, study completion rate, protocol adherence, and completeness of data collection.
Secondary objectives include preliminary assessment of pain intensity, opioid consumption, early mobility, and treatment-related complications. The results of this pilot study will provide essential information for the design, sample size calculation, and implementation of a future adequately powered randomized controlled trial.
Feasibility criteria for progression to a future randomized controlled trial will be considered achieved if:
- Recruitment rate ≥70%
- Study completion rate ≥80%
- Protocol adherence ≥80%
- Missing data <10%
- Serious intervention-related adverse events <10%
- Conditions
- Postamputation Pain, Lower Limb Amputation, Combat Trauma
- Being tested
- Continuous Peripheral Nerve Blocks, Peripheral Nerve Cryoablation, Standard multimodal analgesia
- Keywords
- Acute Post-Amputation Pain, BAMS, Early Mobilization, Opioid Consumption, Regional Anesthesia, Military Trauma, Lower Limb Amputation, Combat-Related Injury, Continuous Peripheral Nerve Block, Perineural cetheter, Cryoablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Peripheral Nerve BlocksProcedure or surgery
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 CryoablationProcedure or surgery
Ultrasound-guided preoperative cryoablation of peripheral nerves selected according to the level of lower limb amputation using the CRYO-S® Painless system.
Standard multimodal analgesiaDrug
Standard multimodal analgesia including acetaminophen, non-steroidal anti-inflammatory drugs, pregabalin, optional amitriptyline, and opioid analgesics as needed according to local clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Peripheral Nerve Blocks | Experimental | Participants receive ultrasound-guided continuous peripheral nerve blocks consisting of a sciatic nerve catheter and/or a suprainguinal fascia iliaca (SIFI) catheter. Analgesia is provided with 0.25% bupivacaine administered as intermittent boluses according to clinical need. Receives: Procedure: Continuous Peripheral Nerve Blocks |
| Preoperative Cryoablation | Experimental | Participants receive ultrasound-guided preoperative cryoablation of peripheral nerves selected according to the level of amputation using the CRYO-S® Painless system. Receives: Procedure: Peripheral Nerve Cryoablation |
| Standard Multimodal Analgesia | Active comparator | Participants receive standard multimodal analgesia including acetaminophen, non-steroidal anti-inflammatory drugs, pregabalin, optional amitriptyline, and opioid analgesics as needed. Receives: Drug: Standard multimodal analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Proportion of eligible patients successfully enrolled in the study.
Measured: 4 months
Study Completion Rate
Proportion of enrolled participants who complete the 7-day follow-up and 1-month assessment.
Measured: 1 month
Completeness of Data Collection
Proportion of completed data points for pain, mobility, opioid consumption, and safety assessments.
Measured: 1 month
Secondary outcomes (6)
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.
Measured: Baseline, 24 hours, 48 hours, 72 hours, Day 7, Month 1
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.
Measured: Baseline, 24 hours, 48 hours, 72 hours, Day 7, Month 1
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.
Measured: 24 hours, 72 hours, Day 7, Month 1
Opioid Consumption (MME)
Total opioid consumption expressed as Morphine Milligram Equivalents (MME) during each assessment interval. Higher values indicate greater opioid consumption.
Measured: 24 hours, 48 hours, 72 hours, Day 7
Time to First Standing
Measured: Up to 7 days
Treatment-Related Complications
Measured: Up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postamputation PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kharkiv National Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrii Halushko, Kharkiv National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863921
- Sponsor's protocol ID
- POSTAMP-2026-PILOT
- Acronym
- APAPMACRLLI
- Status last verified
- Oct 2026
- First submitted
- 8 Jun 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Acute Post-Amputation Pain Management in Patients With Combat-Related Lower Limb Injuries
- ClinicalTrials.gov ID
- NCT07863921
- Acronym / sponsor ID
- APAPMACRLLI / POSTAMP-2026-PILOT
- Conditions
- Postamputation Pain, Lower Limb Amputation, Combat Trauma
- Keywords
- Acute Post-Amputation Pain, BAMS, Early Mobilization, Opioid Consumption, Regional Anesthesia, Military Trauma, Lower Limb Amputation, Combat-Related Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Kharkiv National Medical UniversityUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Combat-related lower limb injuries remain a major cause of limb loss among military personnel. Acute post-amputation pain is highly prevalent following amputation or reamputation procedures and represents a significant barrier to recovery. Inadequate pain control may lead to increased opioid consumption, delayed mobilization, prolonged hospitalization, and impaired participation in rehabilitation programs.
Multimodal analgesia remains the standard approach to postoperative pain management; however, opioid requirements often remain substantial despite the use of non-opioid analgesics and adjuvant medications. Regional anesthesia techniques, including continuous peripheral nerve blocks, have demonstrated the potential to improve pain control while reducing opioid exposure. Similarly, cryoablation of peripheral nerves has emerged as a promising technique for prolonged analgesia through reversible interruption of nerve conduction.
Despite growing interest in these interventions, evidence regarding their feasibility, safety, and clinical utility in patients with combat-related amputations remains limited. Furthermore, direct comparisons between continuous peripheral nerve blocks, cryoablation, and standard multimodal analgesia in military trauma populations are scarce.
The present pilot study is designed to evaluate the feasibility of conducting a future randomized controlled trial investigating different approaches to acute post-amputation pain management. Feasibility outcomes will include recruitment rate, study completion rate, protocol adherence, and completeness of data collection.
Secondary objectives include preliminary assessment of pain intensity, opioid consumption, early mobility, and treatment-related complications. The results of this pilot study will provide essential information for the design, sample size calculation, and implementation of a future adequately powered randomized controlled trial.
Feasibility criteria for progression to a future randomized controlled trial will be considered achieved if:
- Recruitment rate ≥70%
- Study completion rate ≥80%
- Protocol adherence ≥80%
- Missing data <10%
- Serious intervention-related adverse events <10%
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous Peripheral Nerve Blocks | Experimental | Procedure: Continuous Peripheral Nerve BlocksParticipants receive ultrasound-guided continuous peripheral nerve blocks consisting of a sciatic nerve catheter and/or a suprainguinal fascia iliaca (SIFI) catheter. Analgesia is provided with 0.25% bupivacaine administered as intermittent boluses according to clinical need. |
| Preoperative Cryoablation | Experimental | Procedure: Peripheral Nerve CryoablationParticipants receive ultrasound-guided preoperative cryoablation of peripheral nerves selected according to the level of amputation using the CRYO-S® Painless system. |
| Standard Multimodal Analgesia | Active comparator | Drug: Standard multimodal analgesiaParticipants receive standard multimodal analgesia including acetaminophen, non-steroidal anti-inflammatory drugs, pregabalin, optional amitriptyline, and opioid analgesics as needed. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
- Ability to provide written informed consent.
Key exclusion criteria (6 listed)
- 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.
- Severe cognitive impairment or psychiatric disorders preventing reliable pain assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Peripheral Nerve BlocksUltrasound-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. | Procedure or surgery | Continuous Peripheral Nerve Blocks |
| Peripheral Nerve CryoablationUltrasound-guided preoperative cryoablation of peripheral nerves selected according to the level of lower limb amputation using the CRYO-S® Painless system. | Procedure or surgery | Preoperative Cryoablation |
| Standard multimodal analgesiaStandard multimodal analgesia including acetaminophen, non-steroidal anti-inflammatory drugs, pregabalin, optional amitriptyline, and opioid analgesics as needed according to local clinical practice. | Drug | Standard Multimodal Analgesia |
Primary outcome
Recruitment Rate
Time frame: 4 months
Proportion of eligible patients successfully enrolled in the study.
Study Completion Rate
Time frame: 1 month
Proportion of enrolled participants who complete the 7-day follow-up and 1-month assessment.
Completeness of Data Collection
Time frame: 1 month
Proportion of completed data points for pain, mobility, opioid consumption, and safety assessments.
6 secondary outcomes
Pain Intensity at Rest (NRS)
Time frame: Baseline, 24 hours, 48 hours, 72 hours, Day 7, Month 1
Pain Intensity During Movement (NRS)
Time frame: Baseline, 24 hours, 48 hours, 72 hours, Day 7, Month 1
Early Mobility (BAMS)
Time frame: 24 hours, 72 hours, Day 7, Month 1
Opioid Consumption (MME)
Time frame: 24 hours, 48 hours, 72 hours, Day 7
Time to First Standing
Time frame: Up to 7 days
Treatment-Related Complications
Time frame: Up to 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Peripheral Nerve Blocks, Peripheral Nerve Cryoablation and Standard multimodal analgesia in people with Postamputation Pain and Lower Limb Amputation, run by Kharkiv National Medical University at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrii Halushko (+380953622699, aihalushko.asp25@knmu.edu.ua), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.