Post-operative analgesia for day-case ankle arthroscopy
ISRCTN | ISRCTN11419005 |
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DOI | https://doi.org/10.1186/ISRCTN11419005 |
Secondary identifying numbers | 6718 |
- Submission date
- 28/05/2010
- Registration date
- 28/05/2010
- Last edited
- 19/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Richard Venn
Scientific
Scientific
Worthing and Southlands Hospitals
Anaesthetics Department
Lyndhurst Road
Worthing
West Sussex
BN11 2DH
United Kingdom
Study information
Study design | Multicentre randomised interventional treatment trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
Scientific title | Post-operative analgesia for day-case ankle arthroscopy: comparison of intra-articular racemic (RS)-bupivacaine with S(-)-bupivacaine |
Study acronym | Bupivacaine study |
Study objectives | 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(s) | Brighton East REC, 12/09/2007, ref: 07/Q1907/34 |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Bupivicaine |
Primary outcome measure | 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 study start date | 29/04/2008 |
Completion date | 01/11/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Planned sample size: 84 |
Key inclusion criteria | Patients aged 18 years and above undergoing day case ankle arthroscopy who have given informed written consent |
Key exclusion criteria | 1. Allergy or intolerance to any drugs used in the study 2. Spinal or epidural anaesthesia 3. Pregnancy |
Date of first enrolment | 29/04/2008 |
Date of final enrolment | 01/11/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Worthing and Southlands Hospitals
West Sussex
BN11 2DH
United Kingdom
BN11 2DH
United Kingdom
Sponsor information
Sussex NHS Research Consortium (UK)
Hospital/treatment centre
Hospital/treatment centre
Research & Development Department
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
England
United Kingdom
Website | http://www.sxrc.nhs.uk/ |
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Funders
Funder type
Industry
Abbott Laboratories Ltd (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
19/09/2016: No publications found, verifying study status with principal investigator.