An Iliopsoas Plane Block After Total Hip Arthroplasty

Total Hip Arthroplasty Clinical Trial

Official title:

An Iliopsoas Plane Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05212038
• Other study ID #: 3-2021-0438
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Total Hip Arthroplasty

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