Condition category
Surgery
Date applied
28/05/2010
Date assigned
28/05/2010
Last edited
19/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Venn

ORCID ID

Contact details

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

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

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

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

Publication citations

Additional files

Editorial Notes

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