Supra-inguinal Fascia Iliaca Compartment Block on Postoperative Management in Total Hip Arthroplasty by Posterior Approach
Primary Purpose
Arthropathy of Hip
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Supra-inguinal fascia iliaca compartment block
Multimodal analgesia and PCA morphine pump
Sponsored by
About this trial
This is an interventional supportive care trial for Arthropathy of Hip
Eligibility 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
Sites / Locations
- CHU de Liège
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Fascia iliaca block
Arm Description
Placebo group: patients have multimodal analgesia without fascia-iliaca compartment block
Patients in this arm have multimodal analgesia with supra-inguinal fascia iliaca compartment block before surgery
Outcomes
Primary Outcome Measures
Opioid sparing
Difference in cumulated morphine consumption in the first 48 hours after surgery
Secondary Outcome Measures
Opioid secondaries effects
incidence of secondary effects related to morphine consumption
Pain management satisfaction: questionnaire
pain management satisfaction score by IPO (International Pain Outcomes) questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04574479
Brief Title
Supra-inguinal Fascia Iliaca Compartment Block on Postoperative Management in Total Hip Arthroplasty by Posterior Approach
Official Title
Impact of Supra-inguinal Fascia Iliaca Compartment Block on Postoperative Opioid Consumption in Total Hip Arthroplasty Interventions by Posterior Approach
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 16, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Hip
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo group: patients have multimodal analgesia without fascia-iliaca compartment block
Arm Title
Fascia iliaca block
Arm Type
Experimental
Arm Description
Patients in this arm have multimodal analgesia with supra-inguinal fascia iliaca compartment block before surgery
Intervention Type
Procedure
Intervention Name(s)
Supra-inguinal fascia iliaca compartment block
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Multimodal analgesia and PCA morphine pump
Intervention Description
Patients in placebo group have classical multimodal approach to postoperative analgesia with morphine administration by PCA pump
Primary Outcome Measure Information:
Title
Opioid sparing
Description
Difference in cumulated morphine consumption in the first 48 hours after surgery
Time Frame
48 hours after the intervention
Secondary Outcome Measure Information:
Title
Opioid secondaries effects
Description
incidence of secondary effects related to morphine consumption
Time Frame
48 hours after the intervention
Title
Pain management satisfaction: questionnaire
Description
pain management satisfaction score by IPO (International Pain Outcomes) questionnaire
Time Frame
48 hours after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
CHU de Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31272654
Citation
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.
Results Reference
background
PubMed Identifier
35705263
Citation
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.
Results Reference
derived
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Supra-inguinal Fascia Iliaca Compartment Block on Postoperative Management in Total Hip Arthroplasty by Posterior Approach
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