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The efficacy of levobupivacaine, ropivacaine and bupivacaine for combined psoas compartment - sciatic nerve block in patients undergoing total hip replacement.


- candidate number2612
- NTR NumberNTR990
- ISRCTNISRCTN16416351
- Date ISRCTN created27-jun-2007
- date ISRCTN requested11-jun-2007
- Date Registered NTR31-mei-2007
- Secondary IDs 
- Public TitleThe efficacy of levobupivacaine, ropivacaine and bupivacaine for combined psoas compartment - sciatic nerve block in patients undergoing total hip replacement.
- Scientific TitleThe efficacy of levobupivacaine, ropivacaine and bupivacaine for combined psoas compartment - sciatic nerve block in patients undergoing total hip replacement.
- ACRONYMThe efficacy of levobupivacaine, ropivacaine and bupivacaine for combined psoas compartment - sciatic nerve block in patients undergoing total hip replacement.
- hypothesisPsoas 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) studiedTotal hip replacement, Psoas compartment block, Sciatic nerve block
- Inclusion criteria1. Age above 18;
2. ASA classification I-III;
3. Total Hip Replacement under general anesthesia.
- Exclusion criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2003
- planned closingdate1-jan-2005
- Target number of participants45
- InterventionsPsoas Compartment - Sciatic Nerve Block given with Bupivacaine, Levobupivacaine or Ropivacaine. Duration of the intervention: 10 min.
- Primary outcomePain (Visual Analog Scale) op T = 4,8,12,24,48 hour post - puncture.
- Secondary outcome1. 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.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESPhD 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
- PublicationsPain Pract. 2008 May 23. [Epub ahead of print]
- Brief summaryAim 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)
- RECORD31-mei-2007 - 23-jun-2008


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