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CompletedNCT01052974KTcolUpdated Nov 1, 2017

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

A Phase 4 interventional study of ropivacaine in Femoral Neck Fracture, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-01.

Sponsored by University Hospital, Angers · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Mar 2009, registered Jan 2010).
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Femoral Neck Fracture

Keywords

  • femoral neck fracture
  • analgesia
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 60 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • femoral neck fracture

Exclusion criteria

Exclusion Criteria:

  • Contraindication with analgesia
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Placebo comparator
    physiological serum

    ropivacaïne controlled by placebo (physiological serum).

    Drug: ropivacaine

  • Active comparator
    ropivacaine

    ropivacaïne controlled by placebo (physiological serum).

    Drug: ropivacaine

Interventions

  • Drugropivacaine

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: from the hospital admission to 24h after surgical operation

07

Study locations

1 site
  • UHAngers
    Angers, 49 933, France
08

References and documents

Publications

  • Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3. PubMed 33238043 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01052974
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Jan 21, 2010
Start date
Mar 26, 2009
Primary completion
May 2010
Completion
Nov 9, 2010
Last update
Nov 1, 2017

Study contacts

Guillaume BOUHOURS
principal investigator · University Hospital, Angers

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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