PRIMA – Pain relief in major amputatio

Not Applicable

• Conditions: Pain relief in major amputation; Surgery

• Registration Number: ISRCTN64207537
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-21
• Last Update Posted: 21 February 2022
• Study Completion: 2023-05-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients aged 18 or over
2. Patients undergoing a primary above or below knee amputation for the symptoms resulting from peripheral vascular disease or diabetes
3. Patients undergoing amputation under general anaesthesia
4. Patients able to consent to amputation and study participation
5. Patients able to participate in assessing their pain using a Visual Analogue Scale

Exclusion Criteria

1. Patients undergoing amputation for malignancy or trauma
2. Through-knee amputation
3. Other guillotine amputations
4. NCEPOD immediate eg:, undergoing amputation for uncontrollable infection/overwhelming infection, immediately life threatening limb ischaemia.
5. Unwillingness/ inability to comply with the requirements for follow-up visits
6. Known allergy or contraindication to receive any constituents of the study anaesthesia
7. Pregnant/lactating women
8. Patients undergoing more proximal or revision amputations on the ipsilateral side
9. Patients with a prior analgesia regime which includes a buprenorphine patch

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-operative pain (VAS) at day 3