Condition category
Musculoskeletal Diseases
Date applied
27/06/2007
Date assigned
27/06/2007
Last edited
28/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.vumc.nl/english/

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

  1. 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.

Additional files

Editorial Notes