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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04574479
Recruitment Status : Completed
First Posted : October 5, 2020
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
Jean François Brichant, University of Liege

Tracking Information
First Submitted Date  ICMJE August 31, 2020
First Posted Date  ICMJE October 5, 2020
Last Update Posted Date May 17, 2022
Actual Study Start Date  ICMJE December 16, 2020
Actual Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2020)
Opioid sparing [ Time Frame: 48 hours after the intervention ]
Difference in cumulated morphine consumption in the first 48 hours after surgery
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2020)
  • Opioid secondaries effects [ Time Frame: 48 hours after the intervention ]
    incidence of secondary effects related to morphine consumption
  • Pain management satisfaction: questionnaire [ Time Frame: 48 hours after the intervention ]
    pain management satisfaction score by IPO (International Pain Outcomes) questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Supra-inguinal Fascia Iliaca Compartment Block on Postoperative Management in Total Hip Arthroplasty by Posterior Approach
Official Title  ICMJE Impact of Supra-inguinal Fascia Iliaca Compartment Block on Postoperative Opioid Consumption in Total Hip Arthroplasty Interventions by Posterior Approach
Brief Summary Find the impact of supra-inguinal fascia iliaca compartment block on postoperative pain management after total hip arthroplasty by posterior surgical approach
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
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.
Primary Purpose: Supportive Care
Condition  ICMJE Arthropathy of Hip
Intervention  ICMJE
  • 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

  • Drug: Multimodal analgesia and PCA morphine pump
    Patients in placebo group have classical multimodal approach to postoperative analgesia with morphine administration by PCA pump
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo group: patients have multimodal analgesia without fascia-iliaca compartment block
    Intervention: Drug: Multimodal analgesia and PCA morphine pump
  • Experimental: Fascia iliaca block
    Patients in this arm have multimodal analgesia with supra-inguinal fascia iliaca compartment block before surgery
    Interventions:
    • Procedure: Supra-inguinal fascia iliaca compartment block
    • Drug: Multimodal analgesia and PCA morphine pump
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2022)
86
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2020)
75
Actual Study Completion Date  ICMJE September 2, 2021
Actual Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04574479
Other Study ID Numbers  ICMJE 2020/67
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Jean François Brichant, University of Liege
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Liege
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Liege
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP