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Recruiting NCT07393139

Early Postoperative Pain Following a Limb Amputation

— Observational Amputation, Surgical Pain Management Rehabilitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pain assessment.
Who it may be relevant to
Registry conditions: Amputation, Surgical, Pain Management, Rehabilitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Early Postoperative Pain and Functional Recovery Following a Limb Amputation: a Retrospective Observational Study.

Overview

The primary aim of this study is to characterize the trajectory of pain and functional recovery in the first post-operative period following a limb amputation. Secondarily, this study aims to conduct an exploratory analysis to evaluate potential associations between clinical, demographical and therapeutical variables and primary outcomes including pain intensity, pain control and functional recovery.

Detailed description

This retrospective observational study will be conducted at IRCCS Istituto Ortopedico Rizzoli. All patients who underwent an amputation at the IRCCS Istituto Ortopedico Rizzoli between January 1st 2023 and December 31st 2025 will be screened for eligibility based on predefined inclusion criteria. Once a patient is included into the study, all relevant data will be collected from their medical records.

Interventions

  • Other Pain assessment
    During hospitalization, patients were asked three times daily to rate their pain using the 11 point NRS scale. The highest rating of each day will be extracted from their medical records.

Primary outcome measures

  • Pain intensity [Time frame: up to 30 days]
Secondary outcome measures (1)
  • Functional Recovery [Time frame: up to 30 days]

Eligibility criteria

Inclusion criteria

  • Patients ≥ 18 years of age
  • Patients who underwent an amputation to any limb, regardless of location or diagnosis

Exclusion criteria

  • Patients with severe cognitive impairment or diagnosed with dementia
  • Patients deceased or in critical conditions within 48 hours of the intervention
  • Previous amputation to any limb
  • Admission to the hospital because of a stump revision

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • IRCCS Istituto Ortopedico Rizzoli — Bologna

Publications

  • Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the America PMID 26827847
  • Hsu E, Cohen SP. Postamputation pain: epidemiology, mechanisms, and treatment. J Pain Res. 2013;6:121-36. doi: 10.2147/JPR.S32299. Epub 2013 Feb 13. PMID 23426608
  • Kent ML, Hsia HJ, Van de Ven TJ, Buchheit TE. Perioperative Pain Management Strategies for Amputation: A Topical Review. Pain Med. 2017 Mar 1;18(3):504-519. doi: 10.1093/pm/pnw110. PMID 27402960
  • Limakatso K, Ndhlovu F, Usenbo A, Rayamajhi S, Kloppers C, Parker R. The prevalence and risk factors for phantom limb pain: a cross-sectional survey. BMC Neurol. 2024 Feb 6;24(1):57. doi: 10.1186/s12883-024-03547-w. PMID 38321380
  • Moore RA, Chi CC, Wiffen PJ, Derry S, Rice AS. Oral nonsteroidal anti-inflammatory drugs for neuropathic pain. Cochrane Database Syst Rev. 2015 Oct 5;2015(10):CD010902. doi: 10.1002/14651858.CD010902.pub2. PMID 26436601
  • Spezia MC, Dy CJ, Brogan DM. Phantom Limb Pain Management. J Hand Surg Am. 2025 Feb;50(2):208-215. doi: 10.1016/j.jhsa.2024.09.007. Epub 2024 Oct 21. PMID 39436344

Identifiers

NCT: NCT07393139 · 638/2025/Oss/IOR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗