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NCT Number: NCT07393139

Early Postoperative Pain Following a Limb Amputation

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.

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Key information

Conditions

Amputation, Surgical Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain Management Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Phantom Limb Postoperative Complications Rehabilitation Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location status: Recruiting

Location contact

Antonio Ruggiero

CONTACT

[email protected]

+390516366354

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pain assessment

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. Functional Recovery

    Time frame: up to 30 days

    The number of days required for walking.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Acronym: Pain-Amp

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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