Post-operative analgesia for day-case ankle arthroscopy

ISRCTN ISRCTN11419005
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

Worthing and Southlands Hospitals
Anaesthetics Department
Lyndhurst Road
Worthing
West Sussex
BN11 2DH
United Kingdom

Study information

Study designMulticentre randomised interventional treatment trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titlePost-operative analgesia for day-case ankle arthroscopy: comparison of intra-articular racemic (RS)-bupivacaine with S(-)-bupivacaine
Study acronymBupivacaine study
Study objectives1. 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) studiedTopic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Anaesthetics
InterventionPost-operative, single injection of 20 ml of 0.5% S(-)-bupivicaine or 20 ml 0.5% racemic (RS)-bupivicaine into the ankle joint.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Bupivicaine
Primary outcome measureThe 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 measures1. 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 date29/04/2008
Completion date01/11/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned sample size: 84
Key inclusion criteriaPatients aged 18 years and above undergoing day case ankle arthroscopy who have given informed written consent
Key exclusion criteria1. Allergy or intolerance to any drugs used in the study
2. Spinal or epidural anaesthesia
3. Pregnancy
Date of first enrolment29/04/2008
Date of final enrolment01/11/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Worthing and Southlands Hospitals
West Sussex
BN11 2DH
United Kingdom

Sponsor information

Sussex NHS Research Consortium (UK)
Hospital/treatment centre

Research & Development Department
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
England
United Kingdom

Website http://www.sxrc.nhs.uk/

Funders

Funder type

Industry

Abbott Laboratories Ltd (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

19/09/2016: No publications found, verifying study status with principal investigator.