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

Arthritis of Hip Clinical Trial

— HIPFIB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03069183
• Other study ID #: 838-2017
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 30, 2018
• Est. completion date: May 1, 2022

Study information

• Verified date: July 2018
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: May 1, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis of Hip

Intervention

Drug:
• 0.5% Ropivacaine
Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls 0.5% ropivacaine.
• Normal saline
Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls normal saline.

Locations

Country	Name	City	State
Canada	Holland Orthopedic and Arthritic Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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