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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05212038
Other study ID # 3-2021-0438
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2022
Est. completion date January 5, 2023

Study information

Verified date February 2023
Source Gangnam Severance Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Nielsen et al. reported that when iliopsoas plane block was performed on healthy volunteers, the injection solution in Hip MRI was confined to the myofascial compartment, which was known to include all sensory branches of the femoral nerve that control the hip joint. The maximal muscle strength of knee extension did not decrease before and after Iliopsoas plane block in Volunteer. Since there is no clinical study conducted on patients after the volunteer study, the investigators intend to evaluate the analgesic and motor preserving effects of the iliopsoas plane block in a group of patients undergoing total hip arthroplasty.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date January 5, 2023
Est. primary completion date January 5, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty 2. ASA PS 1-3 Exclusion Criteria: 1. Revision total hip arthroplasty 2. Allergy to drugs used in the study 3. Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal) 4. Estimated glomerular filtration rate < 30 mL/min/1.73m2 5. Opioid dependence 6. Prolongation of PT and aPTT more than twice the upper limit of normal 7. Pre-existing neurological or anatomical disorders of the lower extremities 8. Serious psychiatric disorders

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
iliopsoas plane block group
Ultrasound-guided iliopsoas plane block with 0.75% ropivacaine 10 ml and epinephrine 0.05 ml (1:200,000) 10 ml
sham block group
Ultrasound-guided iliopsoas plane block with normal saline 10 ml

Locations

Country Name City State
Korea, Republic of Ji Yeong Kim Seoul

Sponsors (1)

Lead Sponsor Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numeric rating scale pain score at rest Pain intensity at rest will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) 1, 6, 24, and 48 hours after the surgery. up to 48 hours after the surgery
Secondary Numeric rating scale pain score at movement Pain intensity during 45-degree passive flexion of the hip with the ipsilateral knee flexed naturally will be evaluated by an 11-point numeric rating scale (NRS: 0 = no pain, 10 = worst imaginable pain) 1, 6, 24, and 48 hours after the surgery. up to 48 hours postoperatively
Secondary Postoperative opioid consumption morphine equivalent dose postoperative 24, 48hours
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