NCT05228028

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

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 18, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 22, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed
Last Updated

December 28, 2022

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

January 18, 2022

Last Update Submit

December 26, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Total opioids use for 24 hours

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

    Over the first 24 hours after surgery

Secondary Outcomes (8)

  • Postoperative pain at rest (Numeric rating scale)

    At postoperative 4, 8, 12, 16, 20, 24 hours

  • Postoperative pain with movement (Numeric rating scale)

    At postoperative 4, 8, 12, 16, 20, 24 hours

  • Time to first request for pain medication

    From the end of surgery to discharge, an average of 4 days

  • Incidence of postoperative nausea and vomiting

    Over the first 24 hours after surgery

  • Patient satisfaction score with pain control at 24 hours after surgery

    At 24 hours after surgery

  • +3 more secondary outcomes

Study Arms (2)

fascia iliaca compartement block [FICB] group

EXPERIMENTAL
Procedure: fascia iliaca compartement block

quadratus lumborum block [QLB] group

EXPERIMENTAL
Procedure: quadratus lumborum block

Interventions

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.

Also known as: FICB
fascia iliaca compartement block [FICB] 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.

Also known as: QLB
quadratus lumborum block [QLB] group

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Seokha Yoo, M.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

January 18, 2022

First Posted

February 8, 2022

Study Start

March 22, 2022

Primary Completion

October 21, 2022

Study Completion

December 22, 2022

Last Updated

December 28, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations