Skip to main content
OpenTrials
Completed

NCT Number: NCT01005550

Ropivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Femoral Neck Fracture Femoral Fractures Femoral Neck Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospices Civils de Lyon

Lyon, 69, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

6 mg of ropivacaine

Drug

6 mg of ropivacaine are used for the spinal anaesthesia

8 mg of ropivacaine

Drug

8 mg of ropivacaine are used for the spinal anaesthesia

10 mg of ropivacaine

Drug

10 mg of ropivacaine for the spinal anaesthesia

12 mg of ropivacaine

Drug

12 mg of ropivacaine for the spinal anaesthesia

Primary outcomes

  1. Determine the minimum effective ropivacaine dose for unilateral hypobaric spinal anaesthesia during traumatic femoral neck surgery.

    Time frame: 1 hour (surgery intervention)

Secondary outcomes

  1. Spinal anaesthesia characteristics

    Time frame: 1 hour (surgery intervention)

  2. Hemodynamics consequences

    Time frame: 1 hour (surgery intervention)

  3. Patient and surgeon satisfaction

    Time frame: 1 hour (surgery intervention)

  4. Morbidity and mortality

    Time frame: During 3 days after surgery

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 2, 2009
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.