Early Postoperative Pain Following a Limb Amputation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Ortopedico Rizzoli
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 18 years of age
Patients who underwent an amputation to any limb, regardless of location or diagnosis
Disqualifiers
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
Trial population
All patients that underwent an amputation to any limb at the IRCCS Istituto Ortopedico Rizzoli.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Pain assessment
Other interventionDuring 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Amputees1 intervention
Trial outcomes
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 daysSecondary outcomes
1
Functional Recovery
The number of days required for walking.
Time frame
up to 30 daysSponsors and contacts
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Source ClinicalTrials.gov