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USFIB at the Inguinal Ligament for Total Hip Arthroplasty

Primary Purpose

Post Surgical Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Single shot femoral nerve block
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Surgical Pain focused on measuring femoral nerve block, ultrasound guided, total hip arthroplasty

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients 18 years or older undergoing unilateral hip arthroplasty.
  2. Patient capable to complete informed consent.

Exclusion Criteria:

  1. Pediatric population.
  2. Inability to complete informed consent.
  3. Patient refusal.
  4. Contraindication for regional anesthesia: coagulopathy, anticoagulant use, bleeding disorders, local or systemic infection, local anesthesia allergy.
  5. Presence of neuromuscular deficit including diabetic peripheral neuropathy.

Sites / Locations

  • St. Joseph's Heathcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Single shot femoral nerve block

Placebo femoral nerve block

Arm Description

Ultrasound guided Femoral Nerve Block-40ml of bupivacaine 0.5% with epinephrine

Sterile normal saline solution

Outcomes

Primary Outcome Measures

The primary outcome is number of patients recruited per week and we hope to recruit 2 patients per week.

Secondary Outcome Measures

Number of eligible patients consenting to participate.
Number of patients participating that were randomized and received the study intervention.
Completion of study data collection forms
Incidence of respiratory depression and seizures in participating subjects

Full Information

First Posted
July 26, 2013
Last Updated
March 20, 2018
Sponsor
McMaster University
Collaborators
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT01911949
Brief Title
USFIB at the Inguinal Ligament for Total Hip Arthroplasty
Official Title
An Ultrasound Guided Fascia Iliaca Block Placed at the Level of the Inguinal Ligament for Analgesia After Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
St. Joseph's Healthcare Hamilton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hip replacement surgery is one of the most common elective surgeries in Canada and with this surgery, there is considerable pain after the operation. By decreasing the amount of pain after surgery, the patients may be able to move and walk quicker, resulting in easier physiotherapy sessions, shorter hospital stays and may help to avoid adverse outcomes like nausea and vomiting and being overly sedated. By using ultrasound guided femoral nerve block, it may be an alternative for pain management with minimal side effects for patients having hip replacement surgery.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Surgical Pain
Keywords
femoral nerve block, ultrasound guided, total hip arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single shot femoral nerve block
Arm Type
Experimental
Arm Description
Ultrasound guided Femoral Nerve Block-40ml of bupivacaine 0.5% with epinephrine
Arm Title
Placebo femoral nerve block
Arm Type
Placebo Comparator
Arm Description
Sterile normal saline solution
Intervention Type
Drug
Intervention Name(s)
Single shot femoral nerve block
Other Intervention Name(s)
Femoral Nerve Block with 40ml bupivacaine plus 0.5% epinephrine
Intervention Description
Nerve block in lingual crease using ultrasound guidance
Primary Outcome Measure Information:
Title
The primary outcome is number of patients recruited per week and we hope to recruit 2 patients per week.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Number of eligible patients consenting to participate.
Time Frame
Three months
Title
Number of patients participating that were randomized and received the study intervention.
Time Frame
Three months
Title
Completion of study data collection forms
Time Frame
Three months
Title
Incidence of respiratory depression and seizures in participating subjects
Time Frame
Three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauricio Forero, MD
Organizational Affiliation
St. Joseph's Healthcare Hamilton
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Heathcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
21490024
Citation
Rothwell MP, Pearson D, Hunter JD, Mitchell PA, Graham-Woollard T, Goodwin L, Dunn G. Oral oxycodone offers equivalent analgesia to intravenous patient-controlled analgesia after total hip replacement: a randomized, single-centre, non-blinded, non-inferiority study. Br J Anaesth. 2011 Jun;106(6):865-72. doi: 10.1093/bja/aer084. Epub 2011 Apr 13.
Results Reference
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USFIB at the Inguinal Ligament for Total Hip Arthroplasty

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