Evaluation of Efficacy of Lumbar Plexus Bloc After Hip Surgery

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00150865
First received: September 7, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

Compare lumbar plexus block with ropivacaine 0.475%, 0.4 ml/kg to saline. Each group randomized, includes 30 patients. block performed preoperatively Surgery under general anesthesia. Postoperative evaluation of pain (VAS) as first endpoint, and also morphine consumption via PCA device. Follow-up : 24h.

Expectation : sizeable reduction of pain with block, of duration.


Condition Intervention
Pain
Postoperative
Drug: ropivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Study of Posterior Lumbar Plexus Block for Pain Relief After Hip Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • decrease of postoperative pain

Secondary Outcome Measures:
  • decrease in morphine consumption
  • duraration of analgesic effect

Estimated Enrollment: 60
Study Start Date: September 2001
Estimated Study Completion Date: March 2002
Detailed Description:

Compare lumbar plexus block (randomized)

  • ropivacaine 0.475%, 0.4 ml/kg
  • saline 0.4 ml/kg . Each group includes 30 patients.

Block performed preoperatively.

Surgery under general anesthesia (sufentanil, propofol, atracurium ; maintenance : sevoflurane and nitrous oxide in O2. Sufentanil added peroperatively as clinically needed.

Postoperative evaluation of pain (VAS, by an independant blind observer) as first endpoint, and also morphine consumption via PCA device.

Adverse effects (nausea, vomiting, etc) recorded

Follow-up : 24h. Expectation : sizeable reduction of pain with block, of duration.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults
  • ASA 1-3

Exclusion Criteria:

  • cognitive impairement
  • ASA IV
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150865

Sponsors and Collaborators
University Hospital, Angers
Investigators
Study Director: laurent beydon, MD University Hospital, Angers
Principal Investigator: ibrahim okais, MD Clinique St Leonard
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00150865     History of Changes
Other Study ID Numbers: CP 02-01
Study First Received: September 7, 2005
Last Updated: September 7, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Angers:
ropivacaine
posterior lumbar plexus block
hip arthroplasy
analgesia
postoperative

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014