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

Primary Purpose

Nerve Block, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
fascia iliaca compartement block
quadratus lumborum block
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nerve Block

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

fascia iliaca compartement block [FICB] group

quadratus lumborum block [QLB] group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative pain at rest (Numeric rating scale)
Postoperative pain at rest (Numeric rating scale; minimum 0, maximum 10, a higher score means more pain)
Postoperative pain with movement (Numeric rating scale)
Postoperative pain with movement (Numeric rating scale; minimum 0, maximum 10, a higher score means more pain)
Time to first request for pain medication
Time to first request for pain medication after surgery
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting (%)
Patient satisfaction score with pain control 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)
Quality of Recovery at 24 hours after surgery
Quality of Recovery at 24 hours after surgery assessed by QoR-15 questionnaire
Time to discharge readiness
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)
Hospital length of stay
Days of hospitalization after surgery until discharge

Full Information

First Posted
January 18, 2022
Last Updated
December 26, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05228028
Brief Title
Fascia Iliaca Compartment Block Versus Quadratus Lumborum Block in Total Hip Arthroplasty
Official Title
Suprainguinal Fascia Iliaca Compartment Block Versus Anterior Quadratus Lumborum Block for Analgesia After Total Hip Arthroplasty: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
October 21, 2022 (Actual)
Study Completion Date
December 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Block, Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fascia iliaca compartement block [FICB] group
Arm Type
Experimental
Arm Title
quadratus lumborum block [QLB] group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
fascia iliaca compartement block
Other Intervention Name(s)
FICB
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
quadratus lumborum block
Other Intervention Name(s)
QLB
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total opioids use for 24 hours
Description
Total dose of opioids used upto 24 hours after surgery (morphine milligram equivalents)
Time Frame
Over the first 24 hours after surgery
Secondary Outcome Measure Information:
Title
Postoperative pain at rest (Numeric rating scale)
Description
Postoperative pain at rest (Numeric rating scale; minimum 0, maximum 10, a higher score means more pain)
Time Frame
At postoperative 4, 8, 12, 16, 20, 24 hours
Title
Postoperative pain with movement (Numeric rating scale)
Description
Postoperative pain with movement (Numeric rating scale; minimum 0, maximum 10, a higher score means more pain)
Time Frame
At postoperative 4, 8, 12, 16, 20, 24 hours
Title
Time to first request for pain medication
Description
Time to first request for pain medication after surgery
Time Frame
From the end of surgery to discharge, an average of 4 days
Title
Incidence of postoperative nausea and vomiting
Description
Incidence of postoperative nausea and vomiting (%)
Time Frame
Over the first 24 hours after surgery
Title
Patient satisfaction score with pain control at 24 hours after surgery
Description
Patient satisfaction score with pain control at 24 hours after surgery (minimum 0, maximum 10, a higher score means higher satisfaction)
Time Frame
At 24 hours after surgery
Title
Quality of Recovery at 24 hours after surgery
Description
Quality of Recovery at 24 hours after surgery assessed by QoR-15 questionnaire
Time Frame
At 24 hours after surgery
Title
Time to discharge readiness
Description
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)
Time Frame
From the end of surgery to discharge, an average of 4 days
Title
Hospital length of stay
Description
Days of hospitalization after surgery until discharge
Time Frame
From the end of surgery to discharge, an average of 4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seokha Yoo, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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