Fascia Iliaca Compartment Block Versus Quadratus Lumborum Block in Total Hip Arthroplasty

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05228028
Collaborator
(none)
80
1
2
11
7.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: fascia iliaca compartement block
  • Procedure: quadratus lumborum block
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Suprainguinal Fascia Iliaca Compartment Block Versus Anterior Quadratus Lumborum Block for Analgesia After Total Hip Arthroplasty: a Randomized Controlled Trial
Actual Study Start Date :
Mar 22, 2022
Anticipated Primary Completion Date :
Feb 13, 2023
Anticipated Study Completion Date :
Feb 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: fascia iliaca compartement block [FICB] group

Procedure: fascia iliaca compartement block
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:
  • FICB
  • Experimental: quadratus lumborum block [QLB] group

    Procedure: quadratus lumborum block
    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:
  • QLB
  • Outcome Measures

    Primary Outcome Measures

    1. Total opioids use for 24 hours [Over the first 24 hours after surgery]

      Total dose of opioids used upto 24 hours after surgery (morphine milligram equivalents)

    Secondary Outcome Measures

    1. Postoperative pain at rest (Numeric rating scale) [At postoperative 4, 8, 12, 16, 20, 24 hours]

      Postoperative pain at rest (Numeric rating scale; minimum 0, maximum 10, a higher score means more pain)

    2. Postoperative pain with movement (Numeric rating scale) [At postoperative 4, 8, 12, 16, 20, 24 hours]

      Postoperative pain with movement (Numeric rating scale; minimum 0, maximum 10, a higher score means more pain)

    3. Time to first request for pain medication [From the end of surgery to discharge, an average of 4 days]

      Time to first request for pain medication after surgery

    4. Incidence of postoperative nausea and vomiting [Over the first 24 hours after surgery]

      Incidence of postoperative nausea and vomiting (%)

    5. Patient satisfaction score with pain control at 24 hours after surgery [At 24 hours after surgery]

      Patient satisfaction score with pain control at 24 hours after surgery (minimum 0, maximum 10, a higher score means higher satisfaction)

    6. Quality of Recovery at 24 hours after surgery [At 24 hours after surgery]

      Quality of Recovery at 24 hours after surgery assessed by QoR-15 questionnaire

    7. Time to discharge readiness [From the end of surgery to discharge, an average of 4 days]

      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)

    8. Hospital length of stay [From the end of surgery to discharge, an average of 4 days]

      Days of hospitalization after surgery until discharge

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 03080

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Seokha Yoo, M.D., Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seokha Yoo, Clinical Assistant Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT05228028
    Other Study ID Numbers:
    • 2112-062-1282
    First Posted:
    Feb 8, 2022
    Last Update Posted:
    Mar 28, 2022
    Last Verified:
    Mar 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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 28, 2022