An Iliopsoas Plane Block After Total Hip Arthroplasty

• Sponsor: Gangnam Severance Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05212038
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 22.5
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Total Hip Arthroplasty	Procedure: iliopsoas plane block group; Procedure: sham block group	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel assignmentParallel assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Double
• Primary Purpose: Supportive Care
• Official Title: An Iliopsoas Plane Block for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial
• Actual Study Start Date: Feb 15, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: liopsoas plane block group Arm Description: a iliopsoas plane block before surgery	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 Comparator: sham block group sham block before surgery	Procedure: sham block group; Ultrasound-guided iliopsoas plane block with normal saline 10 ml

Outcome Measures

Primary Outcome Measures

1. Numeric rating scale pain score at rest [up to 48 hours after the surgery]

   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.

Secondary Outcome Measures

1. Numeric rating scale pain score at movement [up to 48 hours postoperatively]

   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.

2. Postoperative opioid consumption [postoperative 24, 48hours]

   morphine equivalent dose

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ji Yeong Kim	Seoul		Korea, Republic of

Sponsors and Collaborators

• Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Do-Hyeong Kim, Associate Professor, Gangnam Severance Hospital
• ClinicalTrials.gov Identifier: NCT05212038
• Other Study ID Numbers: 3-2021-0438
• First Posted: Jan 27, 2022
• Last Update Posted: Jun 16, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 16, 2022