An Iliopsoas Plane Block After Total Hip Arthroplasty

February 14, 2023 updated by: Do-Hyeong Kim, Gangnam Severance Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric rating scale pain score at rest
Time Frame: 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.
up to 48 hours after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric rating scale pain score at movement
Time Frame: 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.
up to 48 hours postoperatively
Postoperative opioid consumption
Time Frame: postoperative 24, 48hours
morphine equivalent dose
postoperative 24, 48hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Actual)

January 5, 2023

Study Completion (Actual)

January 5, 2023

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

January 23, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 3-2021-0438

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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