SFIB vs Anterior QLB in Total Hip Arthroplasty

January 18, 2023 updated by: Serkan Tulgar, Samsun University

Comparison of the Efficiency of Ultrasound-Guided Suprainguinal Fascia Iliaca Block and Anterior Quadratus Lumborum Block in Patients Undergoing Total Hip Arthroplasty Under Spinal Anesthesia

Quadratus lumborum block (QLB) is a facial plane block defined to provide analgesia from T7-L3 dermatomes. There are articles reporting that it is an effective analgesic method in hip surgeries. Suprainguinal fascia iliaca block (SIFIB) also blocks components of the lumbar plexus and provides effective analgesia in hip surgeries. The investigators aim to compare the effectiveness of QLB and SIFIB in patients undergoing primary total hip arthroplasty (THA).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

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 Contact

Study Contact Backup

Study Locations

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) classification I-II-III
  • Scheduled for total hip artroplasty surgery under spinal anesthesia

Exclusion Criteria:

  • Patients who did not want to participate in the study
  • Patients with cognitive dysfunction who cannot evaluate the NRS score and cannot use PCA
  • Known local anesthetics and opioid allergy,
  • Pregnancy or lactation
  • Patients with a contraindication to spinal and regional anesthesia
  • Presence of multiple fractures

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
Active Comparator: Ultrasound Guided Suprainguinal Fascia iliaca Block
Patients randomized to receive suprainguinal fascia iliaca block
Procedure: Ultrasound Guided Suprainguinal Fascia iliaca Block
Patients in this group will be administered SFIB with 50 mL of local anesthetic solution (Bupivacaine %0.25) under ultrasound guidance after the surgery is completed.
Active Comparator: Ultrasound Guided Anterior quadratus lumborum block
Patients randomized to receive anterior quadratus lumborum block
Procedure: Ultrasound Guided Anterior Quadratus Lumborum Block
Patients in this group will be administered anterior QLB with 40 mL of local anesthetic (Bupivacaine %0.25) under ultrasound guidance after the surgery is completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative opioid comsumption
Time Frame: up to 24 hour
Morphine consumptions for both group will be recorded
up to 24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric rating scale for postoperative pain intensity
Time Frame: up to 24 hours
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. (3-6-12-18-24th hour) NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
up to 24 hours
Quality of Recovery (QoR-15)
Time Frame: at 24th hour
The impact of surgical and anesthetic interventions on perioperative quality of life and ability to resume routine life activities will be assessed using the Quality of Recovery (QoR) tool. The QoR-15 scale is a patient-based outcome measure in the form of a 15-item validated questionnaire.
at 24th hour
Presence of quadriceps motor block (defined as paralysis or paresis).
Time Frame: up to 24 hours
Quadriceps motor function will be tested with the patient supine and with the hip and knee flexed at 45º and 90º, respectively. The subject will be asked to extend the knee first against gravity and then against resistance. Quadriceps strength will be graded according to a 3-point scale: normal strength = 0 point (extension against resistance); paresis = 1 point (extension against gravity but not against resistance); and paralysis = 2 points (no extension).
up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsun University

Investigators

  • Principal Investigator: Serkan Tulgar, Samsun Üniversitesi tıp fakültesi, Samsun Eğitim ve Araştırma Hastanesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 18, 2023

Primary Completion (Anticipated)

August 15, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

January 5, 2023

First Submitted That Met QC Criteria

January 5, 2023

First Posted (Actual)

January 13, 2023

Study Record Updates

Last Update Posted (Estimate)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LINRA

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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