[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kharkiv National Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":54},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":5},"100659395","acute-post-amputation-pain-management-after-combat-related-lower-limb-injury-100659395",false,"NCT07863921","Acute Post-Amputation Pain Management After Combat-Related Lower Limb Injury","Optimization of Acute Post-Amputation Pain Management in Patients With Combat-Related Lower Limb Injuries","APAPMACRLLI","Inclusion Criteria:\n\n1. Age 18 to 60 years.\n2. Planned or completed lower limb amputation or reamputation due to combat-related trauma.\n3. Enrollment before amputation\u002Freamputation or within 24 hours after surgery.\n4. Planned or completed lower limb amputation or reamputation requiring postoperative analgesic treatment.\n5. Ability to provide written informed consent.\n\nExclusion Criteria:\n\n1. Refusal to participate in the study.\n2. Inability to provide informed consent.\n3. Allergy or hypersensitivity to amide local anesthetics.\n4. Infection at the planned site of regional anesthesia or catheter placement.\n5. Severe cognitive impairment or psychiatric disorders preventing reliable pain assessment.\n6. Decompensated cardiovascular, respiratory, renal, hepatic, or endocrine disease that may affect study outcomes.","ALL","18 Years","60 Years",{"count":21,"type":22},36,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.\n\nThe 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.\n\nThis 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.\n\nThe 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.\n\nParticipants will be followed for 7 days after surgery, with an additional assessment at 1 month.",[28,29,30],"Postamputation Pain","Lower Limb Amputation","Combat Trauma",[32,33,34,35,36,37,29,38,39,40,41],"Acute Post-Amputation Pain","BAMS","Early Mobilization","Opioid Consumption","Regional Anesthesia","Military Trauma","Combat-Related Injury","Continuous Peripheral Nerve Block","Perineural cetheter","Cryoablation","NOT_YET_RECRUITING","2026-10-06",{"date":45,"type":46},"2026-10-07","ACTUAL",{"date":48,"type":22},"2026-10-10",{"date":50,"type":22},"2027-02-28",{"name":52,"class":53},"Kharkiv National Medical University","OTHER",""]