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Ultrasound-guided Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Total Hip Arthroplasty (HIPFIB)

Primary Purpose

Arthritis of Hip

Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
0.5% Ropivacaine
Normal saline
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis of Hip focused on measuring Fascia Iliaca Block, Total Hip Arthroplasty, Total Hip Replacement, Ultrasound

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 18-75, ASA I-III scheduled to undergo unilateral total hip arthroplasty.

Exclusion Criteria:

  • Patients not providing informed consent.
  • Refusal of treatment plan.
  • Pre-existing medical/neurological/hematologic conditions contraindicated for spinal anesthesia or peripheral nerve blocks.
  • Revision total hip arthroplasty.
  • Known allergy to any of the medications being used.
  • History of drug or alcohol abuse.
  • Patients with chronic pain on slow-release preparations of opioid in excess of 30mg of morphine equivalence per day.
  • Patients with Rheumatoid Arthritis.
  • Patients with psychiatric disorders.
  • Patients with prior surgery in the inguinal region or inguinal hernia
  • Patients unable or unwilling to use Patient Control Analgesia.
  • Diabetic patients with diabetic neuropathy or those with impaired renal function (Creatinine >106).
  • Patients with BMI >45.
  • Patients with body weight <65kg.

Sites / Locations

  • Holland Orthopedic and Arthritic CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

0.5% Ropivacaine

Normal Saline

Arm Description

Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls 0.5% ropivacaine.

Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls normal saline.

Outcomes

Primary Outcome Measures

Opioid Consumption at 24 hours after arrival in post-operative care unit
Opioid consumption at 24 hours after arrival in PACU amongst the various treatment groups will be our primary outcome. Opioid usage for the first 24 hours will be simply determined from the patient-controlled analgesia data in addition to oral narcotics administered.

Secondary Outcome Measures

Pain Scores
Numerical Rating Scale (NRS-11) for pain will be used (0=no pain, 10=terrible pain) as the secondary outcome measure. The NRS score will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours at rest and during mobilization by the treating ward nurse.
Respiratory Depression
Respiratory rate will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours. Respiratory depression will be defined as respiratory rate less than 10 breaths per minute.
Nausea
Nausea will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours. Nausea and Vomiting Scale: 0 = No N & V = Mild N & V, no treatment required = Severe N & V, treatment required = Treatment effective = Treatment ineffective
Vomiting
Vomiting will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours. Nausea and Vomiting Scale: 0 = No N & V = Mild N & V, no treatment required = Severe N & V, treatment required = Treatment effective = Treatment ineffective
Pruritus
Pruritus will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours. Pruritus Scale: 0 = No pruritis = Mild pruritis, no treatment required = Severe pruritis, treatment required = Treatment effective = Treatment ineffective

Full Information

First Posted
February 27, 2017
Last Updated
September 5, 2018
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03069183
Brief Title
Ultrasound-guided Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Total Hip Arthroplasty
Acronym
HIPFIB
Official Title
The Efficacy of Ultrasound-guided Suprainguinal Fascia Iliaca Compartment Block on Early Post-operative Analgesia After Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2018 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Total hip replacement (THR) is a common and major surgical procedure performed in elderly patients with significant comorbidities. Optimizing a patient's anesthetic and analgesic modalities could play a significant role in minimizing the risk of adverse events in the perioperative period and potentially shorten time to discharge and recovery. Establishing a safe and effective post-operative analgesic plan is of central importance to successful THR anesthesia care. The application of ultrasound visualization has improved the efficacy of the fascia iliaca compartment block (FICB). However, ultrasound-guided suprainguinal FICB has not yet been evaluated clinically in a large trial as a method of providing post-operative analgesia following THR. The investigators hypothesize that by performing the suprainguinal fascia iliaca block with ultrasound, it will be possible to achieve superior and more reliable analgesia in the first 24 hours than without a block.
Detailed Description
The search for the optimal pain treatment strategies is a work in progress. As techniques and technology evolve so should our approach for the best analgesic regimen that would minimize unwanted side effects and potential risk and more importantly improve patient satisfaction. The literature has supported the use of peripheral nerve blocks for analgesia as well as improved functional outcome after total knee arthroplasty. The addition of peripheral nerve blocks for THR has been more controversial, as the only effective nerve block, the posterior approach to the lumbar plexus, is an advanced regional technique with potential for serious complications. The application of ultrasound visualization has improved the efficacy of the infrainguinal fascia iliaca block. However, ultrasound guided suprainguinal fascia iliaca block has not yet been evaluated clinically in a large trial as a method of providing post-operative analgesia following primary hip arthroplasty. The investigators hypothesize that by performing the suprainguinal fascia iliaca block with ultrasound, it will be possible to achieve superior and more reliable analgesia than that obtained using the landmark "2-pop" technique and the infrainguinal blocks. The aim of this study is to assess whether the ultrasound guided suprainguinal fascia iliaca block can provide superior early postoperative analgesia in patients undergoing primary hip arthroplasty, and minimizing the pain immediately after the resolution of the spinal anesthetic. The investigators propose to perform the first triple-blinded RCT examining the early analgesic efficacy of ultrasound-guided suprainguinal FICB after THR (lateral approach) under spinal anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis of Hip
Keywords
Fascia Iliaca Block, Total Hip Arthroplasty, Total Hip Replacement, Ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0.5% Ropivacaine
Arm Type
Active Comparator
Arm Description
Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls 0.5% ropivacaine.
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls normal saline.
Intervention Type
Drug
Intervention Name(s)
0.5% Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls 0.5% ropivacaine.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls normal saline.
Primary Outcome Measure Information:
Title
Opioid Consumption at 24 hours after arrival in post-operative care unit
Description
Opioid consumption at 24 hours after arrival in PACU amongst the various treatment groups will be our primary outcome. Opioid usage for the first 24 hours will be simply determined from the patient-controlled analgesia data in addition to oral narcotics administered.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain Scores
Description
Numerical Rating Scale (NRS-11) for pain will be used (0=no pain, 10=terrible pain) as the secondary outcome measure. The NRS score will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours at rest and during mobilization by the treating ward nurse.
Time Frame
Every 4 hours after arrival in post-operative care unit for 24 hours
Title
Respiratory Depression
Description
Respiratory rate will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours. Respiratory depression will be defined as respiratory rate less than 10 breaths per minute.
Time Frame
Every 4 hours after arrival in post-operative care unit for 24 hours
Title
Nausea
Description
Nausea will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours. Nausea and Vomiting Scale: 0 = No N & V = Mild N & V, no treatment required = Severe N & V, treatment required = Treatment effective = Treatment ineffective
Time Frame
Every 4 hours after arrival in post-operative care unit for 24 hours
Title
Vomiting
Description
Vomiting will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours. Nausea and Vomiting Scale: 0 = No N & V = Mild N & V, no treatment required = Severe N & V, treatment required = Treatment effective = Treatment ineffective
Time Frame
Every 4 hours after arrival in post-operative care unit for 24 hours
Title
Pruritus
Description
Pruritus will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours. Pruritus Scale: 0 = No pruritis = Mild pruritis, no treatment required = Severe pruritis, treatment required = Treatment effective = Treatment ineffective
Time Frame
Every 4 hours after arrival in post-operative care unit for 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18-75, ASA I-III scheduled to undergo unilateral total hip arthroplasty. Exclusion Criteria: Patients not providing informed consent. Refusal of treatment plan. Pre-existing medical/neurological/hematologic conditions contraindicated for spinal anesthesia or peripheral nerve blocks. Revision total hip arthroplasty. Known allergy to any of the medications being used. History of drug or alcohol abuse. Patients with chronic pain on slow-release preparations of opioid in excess of 30mg of morphine equivalence per day. Patients with Rheumatoid Arthritis. Patients with psychiatric disorders. Patients with prior surgery in the inguinal region or inguinal hernia Patients unable or unwilling to use Patient Control Analgesia. Diabetic patients with diabetic neuropathy or those with impaired renal function (Creatinine >106). Patients with BMI >45. Patients with body weight <65kg.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ben Safa, MD
Phone
416 480 4864
Email
ben.safa@sunnybrook.ca
Facility Information:
Facility Name
Holland Orthopedic and Arthritic Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2N 3Y7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ben Safa, MD
Phone
416 480 4864
Email
ben.safa@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Stephen Choi, MBBS

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Ultrasound-guided Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Total Hip Arthroplasty

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