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

Femoral Neck Fracture Clinical Trial

— KTcol  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052974
• Other study ID #: AOI2008-07
• Status: Completed
• Phase: Phase 4
• First received: January 19, 2010
• Last updated: October 30, 2017
• Start date: March 26, 2009
• Est. completion date: November 9, 2010

Study information

• Verified date: January 2010
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 9, 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• femoral neck fracture

Exclusion Criteria:

• Contraindication with analgesia

Related Conditions & MeSH terms

• Femoral Neck Fracture
• Femoral Neck Fractures
• Fractures, Bone

Intervention

Drug:
• ropivacaine
A widespread collectively practice for the analgesia in prehospital or preoperative period is the single injection of local anesthetic with the technique of the femoral or iliofascial block. Intervention: Analgesic treatment using a femoral perineural catheter (inserted from the hospital admission) with continuous infusion of ropivacaïne controlled by placebo.

Locations

Country	Name	City	State
France	UHAngers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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