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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04574479
Other study ID # 2020/67
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 16, 2020
Est. completion date September 2, 2021

Study information

Verified date May 2022
Source University of Liege
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date September 2, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Belgium CHU de Liège Liège

Sponsors (1)

Lead Sponsor Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Opioid sparing Difference in cumulated morphine consumption in the first 48 hours after surgery 48 hours after the intervention
Secondary Opioid secondaries effects incidence of secondary effects related to morphine consumption 48 hours after the intervention
Secondary Pain management satisfaction: questionnaire pain management satisfaction score by IPO (International Pain Outcomes) questionnaire 48 hours after the intervention
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