Perioperative Analgesia by Femoral Perineural Catheter for Femoral Neck Fracture - Study KTcol

Phase 4

Completed

• Conditions: Femoral Neck Fracture
• Interventions: Drug: ropivacaine

• Registration Number: NCT01052974
• Lead Sponsor: University Hospital, Angers

Brief Summary

Therapeutic essay of phase IV, monocentric, prospective, randomized, in double-blind during 48 hours(then simple-blind),controlled by placebo.

Abstract:

The increasing incidence of the number of femoral neck fractures and the poor prognosis of this traumatological pathology involves an optimization of the diagnostic, therapeutic and analgesic care.

A widespread collectively practice for the analgesia in prehospital or preoperative period is the single injection ("single shot") of local anesthetic with the technique of the femoral or iliofascial block. Nevertheless the single injection of a dose of local anesthetic associated or not with analgesic adjuvants, due to their pharmacological properties, can't prolong the efficiency of the loco-regional analgesia more than 12 hours.

The aim of our study is to evaluate, in the patients admitted in emergencies for suspicion of femoral neck fractures, the perioperative efficiency of an analgesic treatment using a femoral perineural catheter (inserted from the hospital admission) with continuous infusion of ropivacaïne controlled by placebo (physiological serum).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-26
• Status Verified: 2010-01
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Primary Completion: 2010-05
• Study Completion: 2010-11-09
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• femoral neck fracture

Exclusion Criteria

• Contraindication with analgesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ropivacaine	ropivacaine	ropivacaïne controlled by placebo (physiological serum).
physiological serum	ropivacaine	ropivacaïne controlled by placebo (physiological serum).

Primary Outcome Measures

Name	Time	Method
evaluate, in the patients admitted in emergencies for suspicion of femoral neck fractures, the perioperative efficiency of an analgesic treatment using a femoral perineural catheter	from the hospital admission to 24h after surgical operation

Trial Locations

Locations (1)

UHAngers; 🇫🇷 Angers, France