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

The Efficacy of Ultrasound-guided Suprainguinal Fascia Iliaca Compartment Block on Early Post-operative Analgesia After Total Hip Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Arthritis of Hip
• Intervention / Treatment: Drug: 0.5% Ropivacaine; Drug: Normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M2N 3Y7
      • Holland Orthopedic and Arthritic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 0.5% Ropivacaine; Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls 0.5% ropivacaine.	Drug: 0.5% Ropivacaine; Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls 0.5% ropivacaine.; Other Names: Naropin
Placebo Comparator: Normal Saline; Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls normal saline.	Drug: Normal saline; Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls normal saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Every 4 hours after arrival in post-operative care unit for 24 hours
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.	Every 4 hours after arrival in post-operative care unit for 24 hours
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	Every 4 hours after arrival in post-operative care unit for 24 hours
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	Every 4 hours after arrival in post-operative care unit for 24 hours
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	Every 4 hours after arrival in post-operative care unit for 24 hours

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2018
• Primary Completion (Actual): April 27, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Ultrasound; Total Hip Arthroplasty; Fascia Iliaca Block; Total Hip Replacement
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 838-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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