Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6718
Study information
Scientific title
Post-operative analgesia for day-case ankle arthroscopy: comparison of intra-articular racemic (RS)-bupivacaine with S(-)-bupivacaine
Acronym
Bupivacaine study
Study hypothesis
1. To investigate whether intra-articular S(-)-bupivicaine provides prolonged duration of post-operative analgesia in comparison to racemic (RS)-bupivicaine following ankle arthroscopy
2. To investigate whether intra-articular S(-)-bupivicaine reduces supplemental analgesia requirements in comparison to racemic (RS)-bupivicaine following ankle arthroscopy
Ethics approval
Brighton East REC, 12/09/2007, ref: 07/Q1907/34
Study design
Multicentre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Anaesthetics
Intervention
Post-operative, single injection of 20 ml of 0.5% S(-)-bupivicaine or 20 ml 0.5% racemic (RS)-bupivicaine into the ankle joint.
Intervention type
Drug
Phase
Not Applicable
Drug names
Bupivicaine
Primary outcome measures
The analgesic effect of treatments:
1. Time to first supplemental analgesia following discharge from recovery
2. Visual Analogue Scale (VAS) at 30 mins, 1 hour
Secondary outcome measures
1. Differences in VAS scores between intra-articular chirocaine and marcain in the first 24 hours
2. Investigate whether intra-articular chirocaine reduces supplemental analgesia requirements in comparison to marcain in the first 24 hours
Overall trial start date
29/04/2008
Overall trial end date
01/11/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Patients aged 18 years and above undergoing day case ankle arthroscopy who have given informed written consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 84
Participant exclusion criteria
1. Allergy or intolerance to any drugs used in the study
2. Spinal or epidural anaesthesia
3. Pregnancy
Recruitment start date
29/04/2008
Recruitment end date
01/11/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Worthing and Southlands Hospitals
West Sussex
BN11 2DH
United Kingdom
Sponsor information
Organisation
Sussex NHS Research Consortium (UK)
Sponsor details
Research & Development Department
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Abbott Laboratories Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary