Post-Amputation Stump Infection as a Predictor of Persistent Residual Limb Pain: A Prospective Cohort Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorUkrainian Society of Regional Anesthesia and Pain Therapy

About this trial

Persistent residual limb pain is common after traumatic amputation and significantly impairs rehabilitation and prosthetic use. Postoperative stump infection may contribute to peripheral nerve sensitization, scar fibrosis, and long-term pain persistence. This prospective cohort study aims to determine whether early post-amputation stump infection independently predicts persistent clinically significant residual limb pain at 3 and 6 months after surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Traumatic upper or lower limb amputation

Enrollment within 4 weeks after surgery

Ability to provide informed consent

Disqualifiers

Pre-existing chronic pain in the affected limb

Severe cognitive impairment

Terminal illness limiting follow-up

Refusal or inability to complete follow-up assessments

Trial population

The study population will consist of adult patients (≥18 years) undergoing traumatic upper or lower limb amputation following blast-related, drone-related, or other high-energy injuries. Participants will be enrolled within 4 weeks after primary amputation surgery and followed prospectively for 6 months. The population represents individuals at risk of developing persistent residual limb pain during the early postoperative and rehabilitation period.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 1 trial group
Group A: Stump Infection

Trial outcomes

Primary outcomes

1

Persistent Clinically Significant Residual Limb Pain

Presence of clinically significant residual limb pain defined as Numeric Rating Scale (NRS) ≥4 at rest or during movement at 3 months after amputation.

Time frame
3 months

Secondary outcomes

1

Persistent Residual Limb Pain at 6 Months

NRS ≥4 at rest or during movement at 6 months after amputation.

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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