Hip Fracture and Perineural Catheter

Elderly Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638845
• Other study ID #: 2008/072/HP
• Status: Completed
• Phase: N/A
• First received: June 22, 2012
• Last updated: August 16, 2016
• Start date: July 2012
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

INTRODUCTION: Hip Fracture is a public health problem because of its constantly increasing frequency and its high morbidity and mortality. The leading cause of death is cardiovascular decompensation, caused by painful phenomena associated with fracture and orthopedic surgery.With hip fracture, epidural local analgesia techniques have proven their benefit in mortality but are associated with numerous side effects that prevent routine use. Peripheral analgesic techniques locoregional the lumbar plexus, much safer, cause a decrease in postoperative pain after surgery for hip fracture and a decrease in mortality at 6 months. Elderly patients suffering from a hip fracture, no study has investigated the effect of local analgesia continuous femoral perineural catheter on the incidence of cardiovascular events in the perioperative period.

OBJECTIVE: The main objective of this work is to show that perineural analgesia block continuous local anesthetic reduces the incidence of cardiovascular complications in the preoperative period of a patient with a hip fracture and fact, show that this technique decreases the incidence of mortality at one year of patients with a hip fracture (secondary objective).

MATERIAL AND METHODS: This is a prospective, multicenter, randomized, descriptive type. It compares two populations of patients: one has a perineural analgesia by continuous infusion via a catheter of ropivacaine (n = 157) associated with a systemic analgesia and the other only systemic analgesia without development of a catheter perineural (n = 157). The duration of patient participation will be 12 months. In the first 24 hours after a hip fracture after randomization, study participants will benefit from the installation under strict asepsis, a continuous block by catheter, placed by an anesthesiologist experienced control room post-interventional. The local analgesia will be provided by continuous administration via the perineural catheter, ropivacaine for 5 days for the treated group. Except the local analgesia protocol, the protocols pre-and postoperative systemic analgesia and general anesthesia will be identical for all participants of the 2 groups, similar to techniques proposed in the context of everyday clinical practice, ensuring analgesia optimal for all patients in the study. The main features will be found three bioassays Troponin IC and 3 electrocardiograms at the entrance to the hospital, J3 and J5 after inclusion. In addition, cardiovascular clinical monitoring and quantification of pain ( will be performed daily for 8 days after inclusion. Finally, an assessment of higher functions by ladder MMS will be conducted at the entrance, J3, J5 and J8. Moreover, a survey of survival at 1 month, 3 months and 1 year will be realized.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Patients with an age greater than or equal to 60 years

• Patients who have written, informed consent was obtained

• Patients evaluated ASA 1, 2 and 3 according to the classification of the American Society of Anesthesiologists (detailed below)

• Patients undergoing surgery for hip fracture

• Time less than 24 hours after a hip fracture

Exclusion Criteria:

• cons indication to regional anesthesia (constitutional or acquired disorder of coagulation, sepsis, local infection of the puncture area, history of vascular surgery prosthetic femoral neuropathy scalable, allergy to local anesthetics)

• weight <40Kg

• Patients receiving treatment hypocoagulable or antiplatelet therapy of type dipyridamole, ticlopidine and platelet aIIbß3 receptor antagonists (excluding aspirin and clopidogrel)

• cons-indication for standardized anesthetic technique in this study

• cons-indication for analgesics used postoperatively (respiratory failure, severe liver failure, brain injury associated with intracranial hypertension, uncontrolled epilepsy, simultaneous treatment with MAOIs, hypersensitivity to opioids)

• Patient unable to give informed consent

• adults under guardianship or curator

• persons not affiliated with a health insurance plan

• A person deprived of liberty

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Elderly

Intervention

Procedure:
• continuous perineural catheter
continuous perineural catheter

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with cardiovascular events during the preoperative period		3 days	Yes