Lower limb amputation Surgery Lower limb amputation
Conditions
Interventions
Perineural infusion of levobupivacaine 1.25 mg/ml versus placebo for 96 hours after surgery.
Sponsors
University Hospitals of Leicester NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients admitted to our vascular unit requiring a below or above knee amputation irrespective of aetiology.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 24/08/2021: 1. Patients not considered for surgical intervention 2. Patients who are deemed unfit to undergo surgery under general anaesthesia 3. Patients undergoing surgery under regional anaesthesia 4. Patients unable to operate a Patient-Controlled Analgesia (PCA) device or cooperate with evaluation of pain scores e.g. those with confusional states 5. Patients unwilling to consent 6. Allergy to any study medication _____ Previous exclusion criteria: 1. Patients not considered for surgical intervention 2. Patients who are deemed unfit to undergo surgery under general anaesthesia 3. Patients unable to operate a Patient-Controlled Analgesia (PCA) device or cooperate with evaluation of pain scores e.g. those with confusional states 4. Patients unwilling to consent 5. Allergy to any study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 15/09/2021: Late stump pain, phantom limb sensations and phantom limb pain up at 6 months after surgery. Previous primary outcome measure: Late stump pain, phantom limb sensations and phantom limb pain up to one year after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 15/09/2021: The following will be measured at 6 weeks, 3 months, and 6 months after surgery: 1. Early postoperative pain and morphine requirements 2. Late effects on mood, physical disability and quality of life, measured using the Late Life disability index (quality of life and disability), the 36-item Short Form health survey (SF-36) inventory, (pain and disability) the McGill pain questionnaire (pain) and the University of Leicester Amputee questionnaire (pain and disability) Previous secondary outcome measures: 1. Early postoperative pain and morphine requirements 2. Late effects on mood, physical disability and quality of life, measured using the Late Life disability index (quality of life and disability), the 36-item Short Form health survey (SF-36) inventory, (pain and disability) the McGill pain questionnaire (pain) and the University of Leicester Amputee questionnaire (pain and disability) Secondary outcomes will be measured at 6 weeks, 3, 6 and up to 12 months after surgery. | — |
Countries
England, United Kingdom
Outcome results
None listed