Hyperbaric intra-thecal ropivacaine - a comparison with hyperbaric bupivacaine with respect to extent and duration of motor block
| ISRCTN | ISRCTN36749569 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36749569 |
| Protocol serial number | N0504163841 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Northumbria Healthcare NHS Trust (UK) |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 23/04/2015
- 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 John Duggan
Scientific
Scientific
Wansbeck General Hospital
Woodhorn Lane
Ashington
NE63 9JJ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Hyperbaric intra-thecal ropivacaine - a comparison with hyperbaric bupivacaine with respect to extent and duration of motor block |
| Study objectives | 1. Does intra-thecal hyperbaric ropivacaine result in motor block of shorter duration when compared with an equal dose of bupivacaine (of equal baricity and concentration)? 2. Furthermore, does intra-thecal hyperbaric ropivacaine produce a sensory block of similar extent and duration to an equal dose of intra-thecal bupivacaine of equal baricity and concentration? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Anaesthesia |
| Intervention | 40 patients undergoing spinal anaethesia would be recruited to our study and randomised to receive equal hyperbaric doses of either 0.5% bupivacaine in 8% glucose solution or 0.5% ropivacaine in 8% glucose solution. The solutions would be of similar anaesthesia under standardised conditions, we would measure a number of parameters of particular interest. After surgery, we would study the recovery profile of all recruited subjects for the duration of time taken to achieve complete neurological recovery. We would record strength of dorsi-flexion in 15 minute intervals and time to regression of sensory block. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ropivacaine, bupivacaine |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Elective surgery 2. Patient and surgery appropriate for spinal anaesthesia 3. ASA grade <3 4. Age >18 years 5. Non-pregnant 6. No known sensitivities to amide class of local anaesthetics 7. Not currently or recently (<3 months) recruited to other clinical trials |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/2005 |
| Date of final enrolment | 01/05/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Wansbeck General Hospital
Ashington
NE63 9JJ
United Kingdom
NE63 9JJ
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 |
