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

Primary Purpose

Femoral Neck Fracture

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
ropivacaine
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fracture focused on measuring femoral neck fracture, analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • femoral neck fracture

Exclusion Criteria:

  • Contraindication with analgesia

Sites / Locations

  • UHAngers

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

physiological serum

ropivacaine

Arm Description

ropivacaïne controlled by placebo (physiological serum).

ropivacaïne controlled by placebo (physiological serum).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 19, 2010
Last Updated
October 30, 2017
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT01052974
Brief Title
Perioperative Analgesia by Femoral Perineural Catheter for Femoral Neck Fracture - Study KTcol
Acronym
KTcol
Official Title
Perioperative Analgesia by Femoral Perineural Catheter for Femoral Neck Fracture - Study KTcol -
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
March 26, 2009 (Actual)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
November 9, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fracture
Keywords
femoral neck fracture, analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
physiological serum
Arm Type
Placebo Comparator
Arm Description
ropivacaïne controlled by placebo (physiological serum).
Arm Title
ropivacaine
Arm Type
Active Comparator
Arm Description
ropivacaïne controlled by placebo (physiological serum).
Intervention Type
Drug
Intervention Name(s)
ropivacaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: femoral neck fracture Exclusion Criteria: Contraindication with analgesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume BOUHOURS
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
UHAngers
City
Angers
ZIP/Postal Code
49 933
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33238043
Citation
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.
Results Reference
derived

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

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