Ropivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery

May 23, 2019 updated by: Hospices Civils de Lyon

Determining the Minimum Effective Ropivacaine Dose for Unilateral Hypobaric Spinal Anaesthesia During Traumatic Femoral Neck Surgery in the Aged Person: Prospective Comparative Randomized Study

This is a prospective, monocentric, randomized study, comparing the effectiveness and tolerance of four different dosages of hypobaric ropivacaine for unilateral spinal anaesthesia during traumatic femoral neck surgery in the elderly.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69
        • Hospices Civils De Lyon

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

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • older than 70
  • dorsal decubitus surgery
  • ASA score 1, 2, 3
  • MMS score > or equal to 25

Exclusion Criteria:

  • local anesthetic allergy
  • spinal anaesthetic exclusion
  • MMS score lower than 25

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 6 mg of ropivacaine
6 mg of ropivacaine are used for the spinal anaesthesia
Drug: 6 mg of ropivacaine
6 mg of ropivacaine are used for the spinal anaesthesia
Experimental: 8 mg of ropivacaine
8 mg of ropivacaine are used for the spinal anaesthesia
Drug: 8 mg of ropivacaine
8 mg of ropivacaine are used for the spinal anaesthesia
Experimental: 10 mg of ropivacaine
10 mg of ropivacaine are used for the spinal anaesthesia
Drug: 10 mg of ropivacaine
10 mg of ropivacaine for the spinal anaesthesia
Experimental: 12 mg of ropivacaine
12 mg of ropivacaine are used for the spinal anaesthesia
Drug: 12 mg of ropivacaine
12 mg of ropivacaine for the spinal anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the minimum effective ropivacaine dose for unilateral hypobaric spinal anaesthesia during traumatic femoral neck surgery.
Time Frame: 1 hour (surgery intervention)
1 hour (surgery intervention)

Secondary Outcome Measures

Outcome Measure
Time Frame
Spinal anaesthesia characteristics
Time Frame: 1 hour (surgery intervention)
1 hour (surgery intervention)
Hemodynamics consequences
Time Frame: 1 hour (surgery intervention)
1 hour (surgery intervention)
Patient and surgeon satisfaction
Time Frame: 1 hour (surgery intervention)
1 hour (surgery intervention)
Morbidity and mortality
Time Frame: During 3 days after surgery
During 3 days after surgery

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Pascal MEURET, MD, Hospices Civils De Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

August 14, 2009

First Submitted That Met QC Criteria

October 30, 2009

First Posted (Estimate)

November 1, 2009

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008.519

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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