Post-operative analgesia for day-case ankle arthroscopy: Comparison of intra-articular racemic (RS)-bupivicaine with S(-)-bupivicaine.

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2007
INTERVENTION: Trade Name: Chirocaine Pharmaceutical Form: Solution for injection Trade Name: Marcain Pharmaceutical Form: Solution for injection CONDITION: ankle arthroscopy ; MedDRA version: 9.1 Level: LLT Classification code 10002183 Term: Analgesia intra/post op PRIMARY OUTCOME: Main Objective: 1. To investigate whether intra‐articular S(‐)‐bupivicaine provides prolonged duration of post‐operative analgesia in comparison to racemic (RS)‐bupivicaine following ankle arthroscopy Primary end point(s): To investigate whether intra‐articular S(‐)‐bupivicaine provides prolonged duration of post‐operative analgesia in comparison to racemic (RS)‐bupivicaine following ankle arthroscopy. Difference in time to first rescue analgesia following discharge from recovery will used as primary efficacy measure. Secondary Objective: 2. To investigate whether intra‐articular S(‐)‐bupivicaine reduces supplemental analgesia requirements in comparison to racemic (RS)‐bupivicaine following ankle arthroscopy; INCLUSION CRITERIA: Patients aged over 18 years undergoing day case ankle arthroscopy who have given informed written consent 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
Epistemonikos ID: 82d09d14a3fb1860115394b1d3e6099650f160ef
First added on: Aug 21, 2024