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 design	Multicentre randomised interventional treatment trial
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
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

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 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.