NCT05212038

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

January 11, 2022

Last Update Submit

February 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Numeric rating scale pain score at movement

    up to 48 hours postoperatively

  • Postoperative opioid consumption

    postoperative 24, 48hours

Study Arms (2)

liopsoas plane block group

EXPERIMENTAL

Arm Description: a iliopsoas plane block before surgery

Procedure: iliopsoas plane block group

sham block group

SHAM COMPARATOR

sham block before surgery

Procedure: sham block group

Interventions

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

liopsoas plane block group

Ultrasound-guided iliopsoas plane block with normal saline 10 ml

sham block group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty
  • ASA PS 1-3

You may not qualify if:

  • Revision total hip arthroplasty
  • Allergy to drugs used in the study
  • Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
  • Estimated glomerular filtration rate \< 30 mL/min/1.73m2
  • Opioid dependence
  • Prolongation of PT and aPTT more than twice the upper limit of normal
  • Pre-existing neurological or anatomical disorders of the lower extremities
  • Serious psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ji Yeong Kim

Seoul, South Korea

Location

Related Publications (1)

  • Kim JY, Lee JS, Kim JY, Yoon EJ, Lee W, Lee S, Kim DH. Iliopsoas plane block does not improve pain after primary total hip arthroplasty in the presence of multimodal analgesia: a single institution randomized controlled trial. Reg Anesth Pain Med. 2025 Mar 5;50(3):257-263. doi: 10.1136/rapm-2023-105092.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Parallel assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 27, 2022

Study Start

February 15, 2022

Primary Completion

January 5, 2023

Study Completion

January 5, 2023

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations