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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-001728-10-GB

Enrollment

Registered

2007-04-17

Start date

2007-09-12

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

ankle arthroscopy MedDRA version: 9.1 Level: LLT Classification code 10002183 Term: Analgesia intra/post op

Interventions

Trade Name: Chirocaine Pharmaceutical Form: Solution for injection Trade Name: Marcain Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Allergy or intolerance to any drugs used in the study 2. Spinal or epidural anaesthesia 3. Pregnancy

Design outcomes

Primary

Measure	Time frame
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; Secondary Objective: 2. To investigate whether intra-articular S(-)-bupivicaine reduces supplemental analgesia requirements 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.	—

Measure

Time frame

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; Secondary Objective: 2. To investigate whether intra-articular S(-)-bupivicaine reduces supplemental analgesia requirements 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.

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Countries

United Kingdom

Outcome results

None listed

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