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
Secondary identifying numbers NTR990
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

Vrije University Medical Centre
Department of Anaesthesiology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

+31 (0)20 444 0029
rsgm.perez@vumc.nl

Study information

Study designRandomised, controlled, double blinded, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesPsoas 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) studiedPsoas compartment block, sciatic nerve block, total hip replacement
InterventionPsoas compartment - sciatic nerve block given with bupivacaine, levobupivacaine or ropivacaine.
Duration of the intervention: 10 minutes
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Bupivacaine, levobupivacaine, ropivacaine
Primary outcome measurePain (Visual Analog Scale) at T = 4, 8, 12, 24, 48 hours post-puncture.
Secondary outcome measures1. 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 study start date01/06/2003
Completion date01/01/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexNot Specified
Target number of participants45
Key inclusion criteria1. Age above 18
2. American Society of Anaesthesiologists (ASA) classification I - III
3. Total Hip Replacement under general anaesthesia
Key exclusion criteria1. 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 enrolment01/06/2003
Date of final enrolment01/01/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Vrije University Medical Centre
Amsterdam
1007 MB
Netherlands

Sponsor information

Vrije University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre

Department of Anesthesiology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

http://www.vumc.nl/english/
ROR logo https://ror.org/00q6h8f30

Funders

Funder type

Hospital/treatment centre

Vrije University Medical Centre (VUMC) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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
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