| - candidate number | 2612 |
| - NTR Number | NTR990 |
| - ISRCTN | ISRCTN16416351 |
| - Date ISRCTN created | 27-jun-2007 |
| - date ISRCTN requested | 11-jun-2007 |
| - Date Registered NTR | 31-mei-2007 |
| - Secondary IDs | |
| - Public Title | The efficacy of levobupivacaine, ropivacaine and bupivacaine for combined psoas compartment - sciatic nerve block in patients undergoing total hip replacement. |
| - Scientific Title | The efficacy of levobupivacaine, ropivacaine and bupivacaine for combined psoas compartment - sciatic nerve block in patients undergoing total hip replacement. |
| - ACRONYM | The efficacy of levobupivacaine, ropivacaine and bupivacaine for combined psoas compartment - sciatic nerve block in patients undergoing total hip replacement. |
| - hypothesis | Psoas Compartment - Sciatic Nerve Block, as an adjuvant locoregional anesthetic technique, gives sufficient post operative pain reduction after total hip replacement, regardless which long acting local anesthetic ((levo)bupivacaine or ropivacaine in equipotent dosages) is used. |
| - Healt Condition(s) or Problem(s) studied | Total hip replacement, Psoas compartment block, Sciatic nerve block |
| - Inclusion criteria | 1. Age above 18; 2. ASA classification I-III; 3. Total Hip Replacement under general anesthesia. |
| - Exclusion criteria | 1. Co-agulation disorders; 2. Infections at puncture sites; 3. Known allergy to local anesthetics; 4. Pre-existing neurological dysfunction; 5. Not been able to proper communication. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Not applicable |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-jun-2003 |
| - planned closingdate | 1-jan-2005 |
| - Target number of participants | 45 |
| - Interventions | Psoas Compartment - Sciatic Nerve Block given with Bupivacaine, Levobupivacaine or Ropivacaine. Duration of the intervention: 10 min. |
| - Primary outcome | Pain (Visual Analog Scale) op T = 4,8,12,24,48 hour post - puncture. |
| - Secondary outcome | 1. Degree of motor block (Modified Bromage Scale).op T = 4,8,12,24,48 hour post - puncture; 2. Degree of sensory block (Loss of pin-prick sensation in leg dermatomes) op T = 4,8,12,24,48 hour post - puncture. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | PhD Roberto S.G.M. Perez |
| - CONTACT for SCIENTIFIC QUERIES | Marcel A Leeuw, de |
| - Sponsor/Initiator | VU University Medical Center, Department of Anesthesiology |
| - Funding (Source(s) of Monetary or Material Support) | VU University Medical Center, Department of Anesthesiology |
| - Publications | Pain Pract. 2008 May 23. [Epub ahead of print] |
| - Brief summary | Aim of our study is to compare postoperative analgesic efficacy, and the extent of sensory and motor blockade of levobupivacaine, ropivacaine and bupivacaine administered in a combined psoas compartment – sciatic nerve block (PCSNB) for total hip replacement. 45 patients undergoing total hip replacement under general anesthesia combined with PCSNB, were randomly assigned to receive either 50 cc levobupivacaine 3 mg/ml, 50 cc ropivacaine 4.5 mg/ml or 50 cc bupivacaine 3 mg/ml with epinephrine. Postoperative, the pain intensity at rest (VAS), the degree of motor block (modified Bromage Scale) and the extent of sensory block (pin prick test) will be recorded at 4, 8, 12, 24 and 48 hours following initial injection in a double blind fashion. |
| - Main changes (audit trail) | |
| - RECORD | 31-mei-2007 - 23-jun-2008 |
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