Contact information
Type
Scientific
Primary contact
Dr Roberto S.G.M. Perez
ORCID ID
Contact details
Vrije University Medical Centre
Department of Anaesthesiology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 0029
rsgm.perez@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR990
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received from the local medical ethics committee
Study design
Randomised, controlled, double blinded, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Bupivacaine, levobupivacaine, ropivacaine
Primary outcome measures
Pain (Visual Analog Scale) at T = 4, 8, 12, 24, 48 hours post-puncture.
Secondary outcome measures
1. Degree of motor block (Modified Bromage Scale) at T = 4, 8, 12, 24, 48 hour post-puncture
2. Degree of sensory block (loss of pin-prick sensation in leg dermatomes) at T = 4, 8, 12, 24, 48 hour post-puncture
Overall trial start date
01/06/2003
Overall trial end date
01/01/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age above 18
2. American Society of Anaesthesiologists (ASA) classification I - III
3. Total Hip Replacement under general anaesthesia
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
45
Participant 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
Recruitment start date
01/06/2003
Recruitment end date
01/01/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Vrije University Medical Centre
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
Vrije University Medical Centre (VUMC) (The Netherlands)
Sponsor details
Department of Anesthesiology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Vrije University Medical Centre (VUMC) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18503623
Publication citations
-
Results
de Leeuw MA, Dertinger JA, Hulshoff L, Hoeksema M, Perez RS, Zuurmond WW, de Lange JJ, The efficacy of levobupivacaine, ropivacaine, and bupivacaine for combined psoas compartment-sciatic nerve block in patients undergoing total hip arthroplasty., Pain Pract, 8, 4, 241-247, doi: 10.1111/j.1533-2500.2008.00209.x.