Amputation, SurgicalPain-AmpNCT07393139
Early Postoperative Pain Following a Limb Amputation
An observational study of Amputation, Surgical and Pain Management, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Surgical, Pain Management, Rehabilitation
- What is being tested?
- Pain assessment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jan 2026to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients that underwent an amputation to any limb at the IRCCS Istituto Ortopedico Rizzoli.
Who may be able to join
- Patients ≥ 18 years of age
- Patients who underwent an amputation to any limb, regardless of location or diagnosis
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136
Antonio Ruggiero, +390516366354, antonio.ruggiero@ior.it
About this study
Official title: 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.
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.
- Conditions
- Amputation, Surgical, Pain Management, Rehabilitation
- Being tested
- Pain assessment
- Keywords
- Phantom limb pain, Amputation, Post-operative
- Medical subject headings
- Agnosia, Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Amputees | Patients that underwent an amputation to any limb at the IRCCS Istituto Ortopedico Rizzoli between January 1st 2023 and December 31st 2025 Receives: Other: Pain assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 30 days
Secondary outcomes (1)
Functional Recovery
The number of days required for walking.
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start9 Jan 2026
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Amputation, SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393139
- Sponsor's protocol ID
- 638/2025/Oss/IOR
- Acronym
- Pain-Amp
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 26827847Hsu 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 23426608Kent 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 27402960Limakatso 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 38321380Moore 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 26436601Spezia 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative Pain and Functional Recovery Following a Limb Amputation: a Retrospective Observational Study.
- ClinicalTrials.gov ID
- NCT07393139
- Acronym / sponsor ID
- Pain-Amp / 638/2025/Oss/IOR
- Conditions
- Amputation, Surgical, Pain Management, Rehabilitation
- Keywords
- Phantom limb pain, Amputation, Post-operative
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amputees | – | Other: Pain assessmentPatients that underwent an amputation to any limb at the IRCCS Istituto Ortopedico Rizzoli between January 1st 2023 and December 31st 2025 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that underwent an amputation to any limb at the IRCCS Istituto Ortopedico Rizzoli.
Key inclusion criteria (2 listed)
- Patients ≥ 18 years of age
- Patients who underwent an amputation to any limb, regardless of location or diagnosis
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain assessmentDuring 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. | Other | Amputees |
Primary outcome
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.
1 secondary outcome
Functional Recovery
Time frame: up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Background: PubMed 26827847Chou 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.
- Background: PubMed 23426608Hsu 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.
- Background: PubMed 27402960Kent 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.
- Background: PubMed 38321380Limakatso 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.
- Background: PubMed 26436601Moore 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.
- Background: PubMed 39436344Spezia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, Surgical and Pain Management, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07393139, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.