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Ropivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01005550
First received: August 14, 2009
Last updated: March 8, 2012
Last verified: December 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Spinal anaesthesia characteristics [ Time Frame: 1 hour (surgery intervention) ] [ Designated as safety issue: No ]
  • Hemodynamics consequences [ Time Frame: 1 hour (surgery intervention) ] [ Designated as safety issue: Yes ]
  • Patient and surgeon satisfaction [ Time Frame: 1 hour (surgery intervention) ] [ Designated as safety issue: No ]
  • Morbidity and mortality [ Time Frame: During 3 days after surgery ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01005550     History of Changes
Other Study ID Numbers: 2008.519
Study First Received: August 14, 2009
Last Updated: March 8, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Leg Injuries
Anesthetics
Ropivacaine
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013