Evaluation of Efficacy of Lumbar Plexus Bloc After Hip Surgery

October 30, 2017 updated by: University Hospital, Angers

Study of Posterior Lumbar Plexus Block for Pain Relief After Hip Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adults
  • ASA 1-3

Exclusion Criteria:

  • cognitive impairement
  • ASA IV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
decrease of postoperative pain

Secondary Outcome Measures

Outcome Measure
decrease in morphine consumption
duraration of analgesic effect

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Study Director: laurent beydon, MD, University Hospital, Angers
  • Principal Investigator: ibrahim okais, MD, Clinique St Leonard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Study Completion

March 1, 2002

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP 02-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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