Ropivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01005550

Enrollment

Registered

2009-11-02

Start date

2009-04-30

Completion date

2012-03-31

Last updated

2019-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Neck Fracture

Keywords

Unilateral spinal anaesthesia, Hypobaric anaesthesia, Ropivacaine, Traumatic hip surgery

Brief summary

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.

Interventions

DRUG6 mg of ropivacaine

6 mg of ropivacaine are used for the spinal anaesthesia

DRUG8 mg of ropivacaine

8 mg of ropivacaine are used for the spinal anaesthesia

DRUG10 mg of ropivacaine

10 mg of ropivacaine for the spinal anaesthesia

DRUG12 mg of ropivacaine

12 mg of ropivacaine for the spinal anaesthesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026