An observational study in Residual Limb Pain, Stump Pain and Post-Amputation Pain, sponsored by Ukrainian Society of Regional Anesthesia and Pain Therapy. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Ukrainian Society of Regional Anesthesia and Pain Therapy · Observational
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.
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.
745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.
This study's planned enrollment of 150 is below the median of 239 across 135 observational studies indexed under Surgical Wound Infection.
Browse Surgical Wound Infection studies →Ukrainian Society of Regional Anesthesia and Pain Therapy is the lead sponsor of 15 studies on the registry; 9 are open to participants now.
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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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who develop postoperative stump infection within 30 days after amputation, defined by clinical signs of infection requiring antibiotic therapy and/or surgical revision.
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
Persistent Residual Limb Pain at 6 Months
NRS ≥4 at rest or during movement at 6 months after amputation.
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Ukrainian Society of Regional Anesthesia and Pain Therapy