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

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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

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

Condition or disease Intervention/treatment Phase
Arthropathy of Hip Procedure: Supra-inguinal fascia iliaca compartment block Drug: Multimodal analgesia and PCA morphine pump Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
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
Official Title: Impact of Supra-inguinal Fascia Iliaca Compartment Block on Postoperative Opioid Consumption in Total Hip Arthroplasty Interventions by Posterior Approach
Actual Study Start Date : December 16, 2020
Actual Primary Completion Date : September 1, 2021
Actual Study Completion Date : September 2, 2021

Resource links provided by the National Library of Medicine


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
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




Primary Outcome Measures :
  1. Opioid sparing [ Time Frame: 48 hours after the intervention ]
    Difference in cumulated morphine consumption in the first 48 hours after surgery


Secondary Outcome Measures :
  1. Opioid secondaries effects [ Time Frame: 48 hours after the intervention ]
    incidence of secondary effects related to morphine consumption

  2. Pain management satisfaction: questionnaire [ Time Frame: 48 hours after the intervention ]
    pain management satisfaction score by IPO (International Pain Outcomes) questionnaire



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04574479


Locations
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Belgium
CHU de Liège
Liège, Belgium, 4000
Sponsors and Collaborators
University of Liege
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jean François Brichant, Head of Anesthesiology Department, University of Liege
ClinicalTrials.gov Identifier: NCT04574479    
Other Study ID Numbers: 2020/67
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents