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RecruitingNCT07393139Pain-AmpUpdated Nov 4, 2026

Early Postoperative Pain Following a Limb Amputation

An observational study in Amputation, Surgical, Pain Management and Rehabilitation, sponsored by Istituto Ortopedico Rizzoli. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Istituto Ortopedico Rizzoli · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 10 months later.
Updated Nov 4, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Amputation, Surgical
  • Pain Management
  • Rehabilitation

Browse trials for

Keywords

  • Phantom limb pain
  • Amputation
  • Post-operative
03

In context

Phantom Limb

163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.

This study's planned enrollment of 150 is above the median of 67 across 25 observational studies indexed under Phantom Limb.

Browse Phantom Limb studies →

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 304 studies on the registry; 103 are open to participants now.

Browse Istituto Ortopedico Rizzoli studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients that underwent an amputation to any limb at the IRCCS Istituto Ortopedico Rizzoli.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Amputees

    Patients that underwent an amputation to any limb at the IRCCS Istituto Ortopedico Rizzoli between January 1st 2023 and December 31st 2025

    Other: Pain assessment

Interventions

  • OtherPain 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.

06

What researchers measure

Primary outcomes

  1. Pain intensity

    Pain intensity was assessed using Numeric Rating Scale (NRS). The NRS is an 11 point scale from 0 to 10, with 0 indicating no pain and 10 representing the worst pain imaginable.

    Time frame: up to 30 days

Secondary outcomes

  1. Functional Recovery

    The number of days required for walking.

    Time frame: up to 30 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 39436344 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Apr 2026→Dec 2026
Nov 4, 2026
Study completion
Apr 2026→Dec 2026
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Primary completion Apr 2026→Dec 2026
    Study completion Apr 2026→Dec 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07393139
Lead sponsor
Istituto Ortopedico Rizzoli
Responsible party
Sponsor
First posted
Feb 6, 2026
Start date
Jan 9, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Nov 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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