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

U

University Hospital, Angers

Status and phase

Completed
Phase 4

Conditions

Femoral Neck Fracture

Treatments

Drug: ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT01052974
AOI2008-07

Details and patient eligibility

About

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).

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • femoral neck fracture

Exclusion criteria

  • Contraindication with analgesia

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

physiological serum
Placebo Comparator group
Description:
ropivacaïne controlled by placebo (physiological serum).
Treatment:
Drug: ropivacaine
ropivacaine
Active Comparator group
Description:
ropivacaïne controlled by placebo (physiological serum).
Treatment:
Drug: ropivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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