From Battlefield to Recovery: Continuous Regional Anaesthesia for War-Related Lower Limb Trauma

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorCharitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)

About this trial

To compare the effectiveness of continuous regional anaesthesia with standard pain management strategies for the treatment of acute pain in patients with war-related lower limb trauma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age ≥18 years

war-related lower limb trauma

hospital admission requiring surgical treatment or wound management

documented pain assessment during hospitalization

Disqualifiers

age <18 years

isolated upper limb trauma

missing key pain outcome data

contraindication to regional anaesthesia prior to treatment

Trial population

The study population will include adult patients with war-related lower limb trauma who are admitted to participating trauma and rehabilitation centers and require inpatient treatment. Injuries may include blast injuries, gunshot wounds, shrapnel injuries, and other combat-related mechanisms affecting the lower extremities. Eligible patients will be those receiving pain management during hospitalization, including continuous regional anaesthesia with peripheral nerve catheters or standard multimodal analgesia. The study will include patients treated at participating institutions such as Vinnytsia National Pirogov Memorial Medical University and the Superhumans Center.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 2 trial groups
Group A: Group A - Continuous Regional Anaesthesia (CRA)
Group B: Group B - Standard Analgesia (Control Group)

Trial outcomes

Primary outcomes

1

Pain intensity measured by Numeric Rating Scale (NRS 0-10) during the first 72 hours after initiation of analgesic treatment.

Pain scores will be recorded: at rest during movement during wound care or dressing changes.

Time frame
Pain intensity will be assessed at 6, 12, 24, 48, and 72 hours after initiation of analgesia.

Secondary outcomes

1

Total opioid consumption during first 72 hours, expressed as morphine milligram equivalents (MME).

Total opioid consumption will be recorded during the first 72 hours after initiation of analgesic treatment. All administered opioids will be converted to morphine milligram equivalents (MME) using standard opioid conversion factors to allow comparison between treatment groups. The cumulative opioid dose will be calculated for each patient and analyzed as a measure of opioid requirement during the acute post-traumatic period.

Time frame
Cumulative opioid consumption during the first 72 hours after initiation of analgesic therapy.

Other outcomes

Sponsors and contacts

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