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

NCT03069183 | Completed Phase 2

• 1 other identifier: 838-2017
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis of Hip

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pain Scores

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

• Respiratory Depression

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

• Nausea

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

• Vomiting

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

• Pruritus

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

Study Arms (2)

0.5% Ropivacaine

ACTIVE COMPARATOR

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

Drug: 0.5% Ropivacaine

Normal Saline

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

0.5% Ropivacaine DRUG

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

Also known as: Naropin

0.5% Ropivacaine

Normal saline DRUG

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

Normal Saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Holland Orthopedic and Arthritic Centre

Toronto, Ontario, M2N 3Y7, Canada

Location

Related Publications (1)

• Safa B, Trinh H, Lansdown A, McHardy PG, Gollish J, Kiss A, Kaustov L, Choi S. Ultrasound-guided suprainguinal fascia iliaca compartment block and early postoperative analgesia after total hip arthroplasty: a randomised controlled trial. Br J Anaesth. 2024 Jul;133(1):146-151. doi: 10.1016/j.bja.2024.04.019. Epub 2024 May 18.

  PMID: 38762396 DERIVED

MeSH Terms

Interventions

Ropivacaine; Saline Solution

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 3, 2017
• Study Start: August 30, 2018
• Primary Completion: April 27, 2022
• Study Completion: May 1, 2022
• Last Updated: December 12, 2023

Record last verified: 2018-07

Locations

CA (1)