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Ropivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01005550
First Posted: November 2, 2009
Last Update Posted: March 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  Purpose
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.

Condition Intervention Phase
Femoral Neck Fracture Drug: 6 mg of ropivacaine Drug: 8 mg of ropivacaine Drug: 10 mg of ropivacaine Drug: 12 mg of ropivacaine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Determining the Minimum Effective Ropivacaine Dose for Unilateral Hypobaric Spinal Anaesthesia During Traumatic Femoral Neck Surgery in the Aged Person: Prospective Comparative Randomized Study

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

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

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

Enrollment: 64
Study Start Date: April 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01005550


Locations
France
Hospices Civils de Lyon
Lyon, France, 69
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Pascal MEURET, MD Hospices Civils de Lyon
  More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01005550     History of Changes
Other Study ID Numbers: 2008.519
First Submitted: August 14, 2009
First Posted: November 2, 2009
Last Update Posted: March 9, 2012
Last Verified: December 2010

Keywords provided by Hospices Civils de Lyon:
Unilateral spinal anaesthesia
Hypobaric anaesthesia
Ropivacaine
Traumatic hip surgery

Additional relevant MeSH terms:
Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Anesthetics
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents