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

NCT ID: NCT01052974

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-26

Study Completion Date

2010-11-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Femoral Neck Fracture

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

femoral neck fracture analgesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

physiological serum

ropivacaïne controlled by placebo (physiological serum).

Group Type PLACEBO_COMPARATOR

ropivacaine

Intervention Type DRUG

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.

ropivacaine

ropivacaïne controlled by placebo (physiological serum).

Group Type ACTIVE_COMPARATOR

ropivacaine

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* femoral neck fracture

Exclusion Criteria

* Contraindication with analgesia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Guillaume BOUHOURS

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UHAngers

Angers, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33238043 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AOI2008-07

Identifier Type: -

Identifier Source: org_study_id