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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03069183
Acronym
HIPFIB
Enrollment
133
Registered
2017-03-03
Start date
2018-08-30
Completion date
2022-05-01
Last updated
2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis of Hip

Keywords

Fascia Iliaca Block, Total Hip Arthroplasty, Total Hip Replacement, Ultrasound

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.

Interventions

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

DRUGNormal saline

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

Sponsors

Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Opioid Consumption at 24 hours after arrival in post-operative care unit24 hoursOpioid 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

MeasureTime frameDescription
Pain ScoresEvery 4 hours after arrival in post-operative care unit for 24 hoursNumerical 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 DepressionEvery 4 hours after arrival in post-operative care unit for 24 hoursRespiratory 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.
NauseaEvery 4 hours after arrival in post-operative care unit for 24 hoursNausea will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours. Nausea and Vomiting Scale: 0 = No N & V 1. = Mild N & V, no treatment required 2. = Severe N & V, treatment required 3. = Treatment effective 4. = Treatment ineffective
VomitingEvery 4 hours after arrival in post-operative care unit for 24 hoursVomiting will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours. Nausea and Vomiting Scale: 0 = No N & V 1. = Mild N & V, no treatment required 2. = Severe N & V, treatment required 3. = Treatment effective 4. = Treatment ineffective
PruritusEvery 4 hours after arrival in post-operative care unit for 24 hoursPruritus will be recorded on arrival to PACU and every 4 hours thereafter for 24 hours. Pruritus Scale: 0 = No pruritis 1. = Mild pruritis, no treatment required 2. = Severe pruritis, treatment required 3. = Treatment effective 4. = Treatment ineffective

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026