- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01911949
USFIB at the Inguinal Ligament for Total Hip Arthroplasty
An Ultrasound Guided Fascia Iliaca Block Placed at the Level of the Inguinal Ligament for Analgesia After Hip Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Ultrasound guided femoral blocks have been studied since the late 90's. A study published in 1997 by Marhofer et al. pointed that ultrasound guidance in a 3-in-1 block (femoral, obturator, lateral cutaneous nerves), improved the quality of the sensory block and reduced the onset time when compared with a nerve-stimulation technique in patients undergoing hip surgery after trauma.(13) In a meta-analysis comparing ultrasound guidance versus electrical nerve-stimulation for peripheral nerve blocks, the authors reported a decreased risk of block failure, shorter procedure time and faster onset time when ultrasound is used.(14)
A systematic review studying the outcomes after Total Hip Arthroplasty concluded that when compared with systemic analgesia the use of femoral nerve block was on unclear benefit.(15) Separate analysis of the two studies included showed that in the Biboulet study, ultrasound was not used to perform the blocks, and pain with activity was not evaluated in the first 24 hours after surgery, time in which the maximum benefit of blocks is observed.(16) In the second study by Singelyn et al. with continuous femoral nerve block, the authors found similar pain relief than with IV Patient Controlled Analgesia morphine with fewer side effects.(17)
While recent publications have demonstrated the analgesia effectiveness of femoral nerve block and fascia iliaca block for hip fractures,(18) there are not references in the literature analyzing the effectiveness of a single shot, ultrasound-guided, femoral nerve block in primary hip arthroplasty. This fact opens up the possibility to continue researching the analgesic effectiveness of this block in a population where the options for handling postoperative pain are limited widely for its side effects together with the use of anticoagulant and anti-thrombotic therapy.
This technique is considered a simple procedure, easy to teach and to learn. If our study shows improvement of the outcomes, it will feasible to incorporate this block as an alternative for pain management after primary hip arthroplasty.
Given the complexity of this proposed randomized-controlled trial, a pilot study was deemed necessary to find out the feasibility and safety of the intervention, rate of patient recruitment and needs for additional personnel.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Heathcare Hamilton
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients 18 years or older undergoing unilateral hip arthroplasty.
- Patient capable to complete informed consent.
Exclusion Criteria:
- Pediatric population.
- Inability to complete informed consent.
- Patient refusal.
- Contraindication for regional anesthesia: coagulopathy, anticoagulant use, bleeding disorders, local or systemic infection, local anesthesia allergy.
- Presence of neuromuscular deficit including diabetic peripheral neuropathy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single shot femoral nerve block
Ultrasound guided Femoral Nerve Block-40ml of bupivacaine 0.5% with epinephrine
|
Nerve block in lingual crease using ultrasound guidance
Other Names:
|
Placebo Comparator: Placebo femoral nerve block
Sterile normal saline solution
|
Nerve block in lingual crease using ultrasound guidance
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary outcome is number of patients recruited per week and we hope to recruit 2 patients per week.
Time Frame: Three months
|
Three months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of eligible patients consenting to participate.
Time Frame: Three months
|
Three months
|
Number of patients participating that were randomized and received the study intervention.
Time Frame: Three months
|
Three months
|
Completion of study data collection forms
Time Frame: Three months
|
Three months
|
Incidence of respiratory depression and seizures in participating subjects
Time Frame: Three months
|
Three months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mauricio Forero, MD, St. Joseph's Healthcare Hamilton
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Anesthetics, Local
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Bupivacaine
- Epinephrine
Other Study ID Numbers
- 12-3688
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post Surgical Pain
-
Stanford UniversityCompletedPost Surgical PainUnited States
-
University of Alabama at BirminghamTerminatedPost Surgical PainUnited States
-
University Health Network, TorontoCompleted
-
University of PennsylvaniaCompletedPost Surgical PainUnited States
-
PfizerTerminated
-
University of Colorado, DenverNational Cancer Institute (NCI)RecruitingCancer | Cannabis Use | Post-Surgical Pain | Post-Surgical ComplicationUnited States
-
East and North Hertfordshire NHS TrustNational Institute for Health Research, United Kingdom; Manuka Doctor UK LtdRecruitingAnalgesia | Post Surgical PainUnited Kingdom
-
Children's Hospital Medical Center, CincinnatiThe Society for Pediatric AnesthesiaActive, not recruiting
-
Laboratorios del Dr. Esteve, S.A.Premier Research Group plcCompletedAcute Post-surgical PainUnited States
-
Defense and Veterans Center for Integrative Pain...Active, not recruiting
Clinical Trials on Single shot femoral nerve block
-
Negovsky Reanimatology Research InstituteRecruitingOsteo Arthritis Knee | GonarthrosisRussian Federation
-
Seattle Children's HospitalUnknownPostoperative PainUnited States
-
University of NebraskaWithdrawnPeripheral Vascular DiseaseUnited States
-
University of PittsburghNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedAnterior Cruciate Ligament RuptureUnited States
-
Chicago Anesthesia Pain SpecialistsCompletedKnee ArthroplastyUnited States
-
Aswan University HospitalCompleted
-
Clinique Medipole GaronneCompletedPrimary Total Knee ArthroplastyFrance
-
Hospital Beatriz ÂngeloWithdrawn
-
Stanford UniversityCompleted
-
McGill University Health Centre/Research Institute...UnknownTotal Knee Arthroplasty Secondary to OsteoarthritisCanada