- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05228028
Fascia Iliaca Compartment Block Versus Quadratus Lumborum Block in Total Hip Arthroplasty
October 25, 2022 updated by: Seokha Yoo, Seoul National University Hospital
Suprainguinal Fascia Iliaca Compartment Block Versus Anterior Quadratus Lumborum Block for Analgesia After Total Hip Arthroplasty: a Randomized Controlled Trial
Patients undergoing total hip arthroplasty are randomly assigned to two groups (fascia iliaca compartement block [FICB] group or quadratus lumborum block [QLB] group).
In the FICB group, ultrasound-guided suprainguinal FICB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is performed on the ipsilateral surgical side at the end of surgery.
In the QLB group, ultrasound-guided anterior QLB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is done on the ipsilateral surgical side at the end of surgery.
A standardized multimodal analgesic regimen is used for postoperative pain control.
The total use of opioids including patient-controlled analgesia and rescue analgesics is compared in both groups for 24 hours after surgery.
The amount of opioids used is compared by conversion to oral morphine equivalent dose.
Pain score at rest and movement during postoperative 24 hours, time to first request for analgesics, the incidence of side effects, patient satisfaction for pain control at postoperative 24 hours, quality of recovery at postoperative 24 hours, time to discharge readiness, and hospital length of stay are compared.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
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
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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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
15 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients between the ages of 19 and 70 undergoing total hip arthroplasty under spinal anesthesia
- Be able to provide written consent to participate in clinical trials, understand the procedures of this clinical trial, and be able to properly fill out patient-reported questionnaires
- ASA physical status classification 1-2
Exclusion Criteria:
- ASA physical status classification 3-4
- Patients who are contraindicated to nerve blocks (hypersensitivity to local anesthetics, infection at the injection site, etc.)
- Patients with chronic pain and taking pain medications, antidepressants, and anticonvulsants
- Other major medical or psychiatric conditions that will affect response to treatment
- Refusal of intravenous patient-controlled analgesia
- Patients determined to be unsuitable for this clinical trial by the researchers
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: fascia iliaca compartement block [FICB] group
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Ultrasound-guided suprainguinal FICB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is done on the ipsilateral surgical side at the end of surgery.
Other Names:
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Experimental: quadratus lumborum block [QLB] group
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Ultrasound-guided anterior QLB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is done on the ipsilateral surgical side at the end of surgery.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total opioids use for 24 hours
Time Frame: Over the first 24 hours after surgery
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Total dose of opioids used upto 24 hours after surgery (morphine milligram equivalents)
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Over the first 24 hours after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain at rest (Numeric rating scale)
Time Frame: At postoperative 4, 8, 12, 16, 20, 24 hours
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Postoperative pain at rest (Numeric rating scale; minimum 0, maximum 10, a higher score means more pain)
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At postoperative 4, 8, 12, 16, 20, 24 hours
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Postoperative pain with movement (Numeric rating scale)
Time Frame: At postoperative 4, 8, 12, 16, 20, 24 hours
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Postoperative pain with movement (Numeric rating scale; minimum 0, maximum 10, a higher score means more pain)
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At postoperative 4, 8, 12, 16, 20, 24 hours
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Time to first request for pain medication
Time Frame: From the end of surgery to discharge, an average of 4 days
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Time to first request for pain medication after surgery
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From the end of surgery to discharge, an average of 4 days
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Incidence of postoperative nausea and vomiting
Time Frame: Over the first 24 hours after surgery
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Incidence of postoperative nausea and vomiting (%)
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Over the first 24 hours after surgery
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Patient satisfaction score with pain control at 24 hours after surgery
Time Frame: At 24 hours after surgery
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Patient satisfaction score with pain control at 24 hours after surgery (minimum 0, maximum 10, a higher score means higher satisfaction)
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At 24 hours after surgery
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Quality of Recovery at 24 hours after surgery
Time Frame: At 24 hours after surgery
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Quality of Recovery at 24 hours after surgery assessed by QoR-15 questionnaire
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At 24 hours after surgery
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Time to discharge readiness
Time Frame: From the end of surgery to discharge, an average of 4 days
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Days of hospitalization after surgery until discharge readiness (defined as satisfying the following three criteria; (1) adequate pain control (numeric rating scale score < 4), (2) no intravenous opioid use in the past 12 hours, and (3) able to walk at least 30 m without time limit)
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From the end of surgery to discharge, an average of 4 days
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Hospital length of stay
Time Frame: From the end of surgery to discharge, an average of 4 days
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Days of hospitalization after surgery until discharge
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From the end of surgery to discharge, an average of 4 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Seokha Yoo, M.D., Seoul National University 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)
March 22, 2022
Primary Completion (Actual)
October 21, 2022
Study Completion (Anticipated)
February 28, 2023
Study Registration Dates
First Submitted
January 18, 2022
First Submitted That Met QC Criteria
February 7, 2022
First Posted (Actual)
February 8, 2022
Study Record Updates
Last Update Posted (Actual)
October 26, 2022
Last Update Submitted That Met QC Criteria
October 25, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2112-062-1282
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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