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Completed

NCT Number: NCT03069183

Ultrasound-guided Suprainguinal Fascia Iliaca Compartment Block for 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.

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Key information

Conditions

Arthritis of Hip

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Holland Orthopedic and Arthritic Centre

Toronto, Ontario, M2N 3Y7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0.5% ropivacaine

Drug

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

Other names: Naropin

normal saline

Drug

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

Primary outcomes

  1. Opioid Consumption at 24 hours after arrival in post-operative care unit

    Time frame: 24 hours

    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 outcomes

  1. Pain Scores

    Time frame: Every 4 hours after arrival in post-operative care unit for 24 hours

    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.

  2. Respiratory Depression

    Time frame: Every 4 hours after arrival in post-operative care unit for 24 hours

    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.

  3. Nausea

    Time frame: Every 4 hours after arrival in post-operative care unit for 24 hours

    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

  4. Vomiting

    Time frame: Every 4 hours after arrival in post-operative care unit for 24 hours

    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

  5. Pruritus

    Time frame: Every 4 hours after arrival in post-operative care unit for 24 hours

    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

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

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

Acronym: HIPFIB

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2017
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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