A randomised double-blind trial to investigate the efficacy of intra-articular bupivacaine for pain relief following ankle arthroscopy
| ISRCTN | ISRCTN07238689 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07238689 |
| Protocol serial number | N0283122707 |
| Sponsor | Department of Health (UK) |
| Funder | Sussex NHS Research Consortium (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 18/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Richard Venn
Scientific
Scientific
Worthing & Southlands Hospitals NHS Trust
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
| Phone | +44 (0)1903 205111 x 5151 |
|---|---|
| richard.venn@wash.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 1. To investigate whether intra-articular bupivacaine provides pain relief following ankle arthroscopy 2. To investigate whether intra-articular bupivacaine reduces supplemental analgesia requirements in the post-operative period |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Pain |
| Intervention | 1. Normal saline 2. 0.5% Bupivacaine |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | bupivacaine |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 48 |
| Key inclusion criteria | 48 patients aged ≥18 years old undergoing day case ankle arthroscopy who have given informed written consent. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2003 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Worthing & Southlands Hospitals NHS Trust
Worthing
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? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2006 | Yes | No |
