Supra-inguinal Fascia Iliaca Compartment Block on Postoperative Management in Total Hip Arthroplasty by Posterior Approach

Impact of Supra-inguinal Fascia Iliaca Compartment Block on Postoperative Opioid Consumption in Total Hip Arthroplasty Interventions by Posterior Approach

Find the impact of supra-inguinal fascia iliaca compartment block on postoperative pain management after total hip arthroplasty by posterior surgical approach

Study Overview

• Status: Completed
• Conditions: Arthropathy of Hip
• Intervention / Treatment: Drug: Multimodal analgesia and PCA morphine pump; Procedure: Supra-inguinal fascia iliaca compartment block

Detailed Description

ASA physical status 1, 2 and 3 patients scheduled to undergo elective surgery of total hip arthroplasty under spinal anesthesia.

The investigators would like to study the impact of supra-inguinal fascia iliaca block on postoperative pain management after total hip arthroplasty by posterior surgical approach. The principal investigator perform this block with ultrasound technique. The investigators also want to observe if this loco-regional new approach to fascia iliaca block could have influence on opioid side effects, postoperative nausea and vomiting, length of hospitalisation and first mobilisation side effects.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • CHU de Liege

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults patients scheduled to undergo elective surgery of total hip arthroplasty by posterior surgical aboard

Exclusion Criteria:

• Patient refusal
• Allergy to used medications or local infection.
• Pregnancy
• Obesity with body mass index > 35
• History of chronic pain or fibromyalgia
• Drug (opioids) addiction
• Treatment with corticosteroids for more than 6 months
• Severe kidney or liver diseases
• Mental disorders or serious neurological diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo group: patients have multimodal analgesia without fascia-iliaca compartment block	Drug: Multimodal analgesia and PCA morphine pump; Patients in placebo group have classical multimodal approach to postoperative analgesia with morphine administration by PCA pump
Experimental: Fascia iliaca block; Patients in this arm have multimodal analgesia with supra-inguinal fascia iliaca compartment block before surgery	Drug: Multimodal analgesia and PCA morphine pump; Patients in placebo group have classical multimodal approach to postoperative analgesia with morphine administration by PCA pump; Procedure: Supra-inguinal fascia iliaca compartment block; Ultrasound guided loco-regional technique as described by Desmet et al. Fascia iliaca compartment block with in-plane 40 ml ropivacaine 0,375% injection between the ilio-psoas muscle and the internal oblique muscle. Patients in SFICB group have classical multimodal approach to postoperative analgesia with morphine administration by PCA pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid sparing	Difference in cumulated morphine consumption in the first 48 hours after surgery	48 hours after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid secondaries effects	incidence of secondary effects related to morphine consumption	48 hours after the intervention
Pain management satisfaction: questionnaire	pain management satisfaction score by IPO (International Pain Outcomes) questionnaire	48 hours after the intervention

Collaborators and Investigators

• Sponsor: University of Liege

Publications and helpful links

General Publications

• Desmet M, Balocco AL, Van Belleghem V. Fascia iliaca compartment blocks: Different techniques and review of the literature. Best Pract Res Clin Anaesthesiol. 2019 Mar;33(1):57-66. doi: 10.1016/j.bpa.2019.03.004. Epub 2019 Apr 17.
• Carella M, Beck F, Piette N, Denys S, Kurth W, Lecoq JP, Bonhomme VL. Effect of suprainguinal fascia iliaca compartment block on postoperative opioid consumption and functional recovery in posterolateral-approached total hip arthroplasty: a single-blind randomized controlled trial. Reg Anesth Pain Med. 2022 Jun 15. pii: rapm-2021-103427. doi: 10.1136/rapm-2021-103427. [Epub ahead of print]

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 2, 2021

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: 2020/67

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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