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

NCT04574479 | Completed Phase 4 DMC

• 1 other identifier: 2020/67
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Arthropathy of Hip

Outcome Measures

Primary Outcomes (1)

• Opioid sparing

  Difference in cumulated morphine consumption in the first 48 hours after surgery

  48 hours after the intervention

Secondary Outcomes (2)

• Opioid secondaries effects

  48 hours after the intervention

• Pain management satisfaction: questionnaire

  48 hours after the intervention

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo group: patients have multimodal analgesia without fascia-iliaca compartment block

Drug: Multimodal analgesia and PCA morphine pump

Fascia iliaca block

EXPERIMENTAL

Patients in this arm have multimodal analgesia with supra-inguinal fascia iliaca compartment block before surgery

Procedure: Supra-inguinal fascia iliaca compartment block; Drug: Multimodal analgesia and PCA morphine pump

Interventions

Supra-inguinal fascia iliaca compartment block PROCEDURE

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

Fascia iliaca block

Multimodal analgesia and PCA morphine pump DRUG

Patients in placebo group have classical multimodal approach to postoperative analgesia with morphine administration by PCA pump

Fascia iliaca block; Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

CHU de Liège

Liège, 4000, Belgium

Location

Related Publications (2)

• 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.

  PMID: 31272654 BACKGROUND

• 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:rapm-2021-103427. doi: 10.1136/rapm-2021-103427. Online ahead of print.

  PMID: 35705263 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Two group simple-blinded RCT: placebo vs fascia iliaca group. Surgeon and patient are blinded of the patient's group. Investigator and loco-regional technique provider know the patient's group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology Department

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: October 5, 2020
• Study Start: December 16, 2020
• Primary Completion: September 1, 2021
• Study Completion: September 2, 2021
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)