The efficacy of levobupivacaine, ropivacaine and bupivacaine for combined psoas compartment - sciatic nerve block in patients undergoing total hip replacement
| ISRCTN | ISRCTN16416351 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16416351 |
| Protocol serial number | NTR990 |
| Sponsor | Vrije University Medical Centre (VUMC) (The Netherlands) |
| Funder | Vrije University Medical Centre (VUMC) (The Netherlands) |
- Submission date
- 27/06/2007
- Registration date
- 27/06/2007
- Last edited
- 28/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Roberto S.G.M. Perez
Scientific
Scientific
Vrije University Medical Centre
Department of Anaesthesiology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 444 0029 |
|---|---|
| rsgm.perez@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, controlled, double blinded, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Psoas compartment - sciatic nerve block, as an adjuvant locoregional anaesthetic technique, gives sufficient post operative pain reduction after total hip replacement, regardless which long acting local anaesthetic ([levo]bupivacaine or ropivacaine in equipotent dosages) is used. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Psoas compartment block, sciatic nerve block, total hip replacement |
| Intervention | Psoas compartment - sciatic nerve block given with bupivacaine, levobupivacaine or ropivacaine. Duration of the intervention: 10 minutes |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bupivacaine, levobupivacaine, ropivacaine |
| Primary outcome measure(s) |
Pain (Visual Analog Scale) at T = 4, 8, 12, 24, 48 hours post-puncture. |
| Key secondary outcome measure(s) |
1. Degree of motor block (Modified Bromage Scale) at T = 4, 8, 12, 24, 48 hour post-puncture |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 45 |
| Key inclusion criteria | 1. Age above 18 2. American Society of Anaesthesiologists (ASA) classification I - III 3. Total Hip Replacement under general anaesthesia |
| Key exclusion criteria | 1. Coagulation disorders 2. Infections at puncture sites 3. Known allergy to local anaesthetics 4. Pre-existing neurological dysfunction 5. Not being able to properly communicate |
| Date of first enrolment | 01/06/2003 |
| Date of final enrolment | 01/01/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Vrije University Medical Centre
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
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 | 01/07/2008 | Yes | No |
