NCT04827121

Brief Summary

Iliac fascia block has a long history of analgesia in patients with hip fractures. A large number of clinical studies have confirmed its efficacy, and there are also randomized controlled studies supporting its effectiveness in analgesia after total hip replacement surgery.Quadratus lumborum block is a new block technique developed in last decade, and there are also a few randomized controlled studies supporting its effectiveness in postoperative analgesia for total hip replacement.The purpose of the present study was to find out whether these two different approaches of fascial compartment block have similar effects on postoperative analgesia after total hip replacement.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

March 30, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 31, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

11 months

First QC Date

March 30, 2021

Last Update Submit

June 5, 2021

Conditions

Keywords

UltrasoundTotal hip arthroplastyNerve block

Outcome Measures

Primary Outcomes (1)

  • Cumulative opioids consumption at 24 hours

    Cumulative consumption of sufentanil from PCA device at 24 hours after surgery

    Within 24 hours

Secondary Outcomes (1)

  • NRS score with movement at 6,12,and 24 hours

    at 6,12,and 24 hours

Study Arms (2)

Fascial iliac compartment block group

ACTIVE COMPARATOR

Patients in this group will recieve supra-inguinal fascial iliac compartment block after anesthesia induction.

Procedure: Fascial iliac compartment block

Quadratus lumborum block group

ACTIVE COMPARATOR

Patients in this group will recieve quadratus lumborum block after anesthesia induction.

Procedure: Quadratus lumborum block

Interventions

Patients will recieve supra-inguinal approach of fascial iliac compartment block under ultrasound guidance with 30 ml of 0.5 percent ropivacaine.

Fascial iliac compartment block group

Patients will recieve transmuscular approach of quadratus lumborum block under ultrasound guidance with 30 ml of 0.5 percent ropivacaine.

Quadratus lumborum block group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA class 1-3
  • BMI between 20-36kg/m\^2
  • Scheduled to undergo total hip replacement

You may not qualify if:

  • A history of chronic opioids or steroid consumption
  • Coagulapathy or anticoagulation
  • Pregnancy
  • Allergic to local anesthetics Neurological dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Wei Mei, PhD

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Anesthesiology Department of Tongji Hospital Affiliated to Huazhong University of Science and Technology

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 1, 2021

Study Start

May 31, 2021

Primary Completion

May 1, 2022

Study Completion

June 1, 2022

Last Updated

June 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations