Ropivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery

Civil Hospices of Lyon

Status and phase: Completed; Phase 4

Conditions: Femoral Neck Fracture

Treatments: Drug: 10 mg of ropivacaine; Drug: 6 mg of ropivacaine; Drug: 12 mg of ropivacaine; Drug: 8 mg of ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01005550

2008.519

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 70+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 4 patient groups

6 mg of ropivacaine

Experimental group

Description:

6 mg of ropivacaine are used for the spinal anaesthesia

Treatment:

Drug: 6 mg of ropivacaine

8 mg of ropivacaine

Experimental group

Description:

8 mg of ropivacaine are used for the spinal anaesthesia

Treatment:

Drug: 8 mg of ropivacaine

10 mg of ropivacaine

Experimental group

Description:

10 mg of ropivacaine are used for the spinal anaesthesia

Treatment:

Drug: 10 mg of ropivacaine

12 mg of ropivacaine

Experimental group

Description:

12 mg of ropivacaine are used for the spinal anaesthesia

Treatment:

Drug: 12 mg of ropivacaine