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

NCT07438795 — Not yet recruiting, 150 participants, Ukrainian Society of Regional Anesthesia and Pain Therapy

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Registry	NCT07438795, acronym INF-STUMP-PAIN
Status	Not yet recruiting
Study type	Observational
Enrollment	150 (Estimated)
Sponsor	Ukrainian Society of Regional Anesthesia and Pain Therapy (Other)
Conditions	Residual Limb Pain, Stump Pain, Post-Amputation Pain, Surgical Site Infection, Phantom Limb Pain (PLP)
Dates	start 2026-06-23 (estimated), primary completion 2026-06-23 (estimated), completion 2026-12-23 (estimated), first posted 2026-02-27, last updated 2026-06-03

-Summary

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.

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+Detailed description

Patients undergoing traumatic limb amputation will be enrolled within 4 weeks after surgery and followed for 6 months. Early postoperative stump infection will be recorded using predefined clinical criteria. Pain intensity (Numeric Rating Scale), neuropathic pain screening (DN4), and phantom limb pain will be assessed at baseline, 3 months, and 6 months. Multivariable logistic regression will be used to evaluate whether stump infection is independently associated with persistent residual limb pain, adjusting for amputation level, injury mechanism, revision surgeries, antibiotic exposure, and demographic factors.

+Arms and interventions

Arm	Type	Interventions	Description
Stump Infection			Participants who develop postoperative stump infection within 30 days after amputation, defined by clinical signs of infection requiring antibiotic therapy and/or surgical revision.

+Outcome measures

Primary outcomes

Persistent Clinically Significant Residual Limb Pain [3 months]: Presence of clinically significant residual limb pain defined as Numeric Rating Scale (NRS) ≥4 at rest or during movement at 3 months after amputation.

Secondary outcomes

Persistent Residual Limb Pain at 6 Months [6 months]: NRS ≥4 at rest or during movement at 6 months after amputation.

+Eligibility

Sex: All, ages: 18 Years to 60 Years

Inclusion Criteria:

* Traumatic upper or lower limb amputation
* Enrollment within 4 weeks after surgery
* Ability to provide informed consent

Exclusion Criteria:

* Pre-existing chronic pain in the affected limb
* Severe cognitive impairment
* Terminal illness limiting follow-up
* Refusal or inability to complete follow-up assessments