Early Postoperative Pain Following a Limb Amputation (Pain-Amp)

January 30, 2026 updated by: Istituto Ortopedico Rizzoli

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40136
        • Recruiting
        • IRCCS Istituto Ortopedico Rizzoli
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: up to 30 days
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.
up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Recovery
Time Frame: up to 30 days
The number of days required for walking.
up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 638/2025/Oss/IOR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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