Post-operative analgesia for day-case ankle arthroscopy
| ISRCTN | ISRCTN11419005 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11419005 |
| Protocol serial number | 6718 |
| Sponsor | Sussex NHS Research Consortium (UK) |
| Funder | Abbott Laboratories Ltd (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Study type | 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Bupivicaine |
| Primary outcome measure(s) |
The analgesic effect of treatments: |
| Key secondary outcome measure(s) |
1. Differences in VAS scores between intra-articular chirocaine and marcain in the first 24 hours |
| Completion date | 01/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Worthing and Southlands Hospitals
West Sussex
BN11 2DH
United Kingdom
BN11 2DH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/09/2016: No publications found, verifying study status with principal investigator.
