POSTOPERATIVE ANALGESIA AFTER OPERATIVE REPAIR OF ANKLE FRACTURE
Conditions
Interventions
Trade Name: CHIROCAINE 0.5%
Product Name: LEVOBUPIVACAINE
Pharmaceutical Form: Solution for injection
Trade Name: CHIROCAINE 0.125%
Pro
Sponsors
Belfast Health & Social Care Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for subjects i) ASA class I-III ii) Patients able to give written informed consent iii) Patients awaiting operative repair of an ankle fracture iv) Aged 18-80 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria i) History of allergy to any of the medications used in the study ii) Pregnancy iii) Local infection at site of nerve blockade iv) Neurological dysfunction in lower limbs. v) Patients suffering from severe hypotension such as cardiogenic or hypovolaemic shock or with a serious cardiac arrhythmia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to determine if a continuous popliteal nerve block in patients undergoing operative repair of ankle fracture will reduce the incidence of chronic pain at 3 months post procedure in comparison to standard care. ; Secondary Objective: Secondary end points (i) Post operative morphine usage in both groups (ii) Time to first mobilisation in both groups (iii) Difference in pain scores in both the postoperative period and on first mobilisation in both groups (iv) Total length of hospital stay in both groups (v) Patient satisfaction in both groups ; Primary end point(s): Primary end point Reduction in the incidence of chronic pain at 3 months post procedure | — |
Countries
United Kingdom
Outcome results
None listed