PRIMA – Pain relief in major amputation

Pain Relief in Major Amputation (PRIMA): A randomised clinical trial comparing pre-incision ‘single-shot’ nerve block and continuous peri-neural catheter for patients undergoing a major lower limb amputation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN64207537

Enrollment

Registered

2021-07-21

Start date

2021-07-12

Completion date

Unknown

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain relief in major amputation Surgery

Interventions

Participant pathway: Patients who have a clinical indication for a major lower limb amputation (MLLA) and meet the inclusion/exclusion criteria will be invited to participate. MLLA can

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Post-operative pain (VAS) at day 3	—

Secondary

Measure	Time frame
1. Anaesthetic and operative times measured using patient records at a single time point 2. Adjunctive pain relief medication such as opioid use, tablets, patches and neuropathic medication measured using patient records at a single time point 3. Daily pain scores (VAS) from immediately post-operatively through to day seven 4. The duration of hospital stay measured using patient records at a single time point 5. Level of engagement and ability to participate in physiotherapy measured using an in-house developed two question physiotherapy tool, for the first seven days 6. The level of opioid induced sedation as measured by the Pasero Opioid-induced Sedation Scale (POSS) daily for the first 7 days then at week 6 7. The level of post operative nausea and vomiting (PONV) as assessed by the PONV impact scale daily for the first 7 days 8. Phantom limb or neuropathic pain as assessed by the S-LANNS daily for the first 7 days then at week 6 and 1 year	—

Measure

Time frame

1. Anaesthetic and operative times measured using patient records at a single time point 2. Adjunctive pain relief medication such as opioid use, tablets, patches and neuropathic medication measured using patient records at a single time point 3. Daily pain scores (VAS) from immediately post-operatively through to day seven 4. The duration of hospital stay measured using patient records at a single time point 5. Level of engagement and ability to participate in physiotherapy measured using an in-house developed two question physiotherapy tool, for the first seven days 6. The level of opioid induced sedation as measured by the Pasero Opioid-induced Sedation Scale (POSS) daily for the first 7 days then at week 6 7. The level of post operative nausea and vomiting (PONV) as assessed by the PONV impact scale daily for the first 7 days 8. Phantom limb or neuropathic pain as assessed by the S-LANNS daily for the first 7 days then at week 6 and 1 year

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026