NCT05684471

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable pain

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 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

January 18, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

January 5, 2023

Last Update Submit

May 7, 2024

Conditions

Pain

Keywords

Postoperative pain managementTotal hip arthroplastySuprainguinal fascia iliaca blockAnterior QLB

Outcome Measures

Primary Outcomes (1)

  • Cumulative opioid comsumption

    Morphine consumptions for both group will be recorded

    up to 24 hour

Secondary Outcomes (3)

  • Numeric rating scale for postoperative pain intensity

    up to 24 hours

  • Quality of Recovery (QoR-15)

    at 24th hour

  • Presence of quadriceps motor block (defined as paralysis or paresis).

    up to 24 hours

Study Arms (2)

Ultrasound Guided Suprainguinal Fascia iliaca Block

ACTIVE COMPARATOR

Patients randomized to receive suprainguinal fascia iliaca block

Procedure: Ultrasound Guided Suprainguinal Fascia iliaca Block

Ultrasound Guided Anterior quadratus lumborum block

ACTIVE COMPARATOR

Patients randomized to receive anterior quadratus lumborum block

Procedure: Ultrasound Guided Anterior Quadratus Lumborum Block

Interventions

Ultrasound Guided Suprainguinal Fascia iliaca BlockPROCEDURE

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.

Ultrasound Guided Suprainguinal Fascia iliaca Block
Ultrasound Guided Anterior Quadratus Lumborum BlockPROCEDURE

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.

Ultrasound Guided Anterior quadratus lumborum block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University

Samsun, 55090, Turkey (Türkiye)

Location

Related Publications (3)

  • James M, Bentley RA, Womack J, Goodman BA. Safety profile and outcome after ultrasound-guided suprainguinal fascia iliaca catheters for hip fracture: a single-centre propensity-matched historical cohort study. Can J Anaesth. 2022 Sep;69(9):1139-1150. doi: 10.1007/s12630-022-02279-0. Epub 2022 Jul 12.

    PMID: 35819630BACKGROUND

  • Wang Q, Hu J, Zhang W, Zeng Y, Yang J, Kang P. Comparison Between Ultrasound-Guided Suprainguinal Fascia Iliaca Block and Anterior Quadratus Lumborum Block for Total Hip Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Trial. J Arthroplasty. 2022 Apr;37(4):763-769. doi: 10.1016/j.arth.2022.01.011. Epub 2022 Jan 11.

    PMID: 35026362BACKGROUND

  • Shamim R, Prasad G, Bais PS, Priya V, Singh TK, Ambasta S, Philips AK. Ultrasound-Guided Suprainguinal Fascia Iliaca Compartment Block for Postoperative Analgesia in Patients Undergoing Hip and Femur Surgeries: A Retrospective Analysis. Anesth Essays Res. 2020 Jul-Sep;14(3):525-530. doi: 10.4103/aer.AER_9_21. Epub 2021 Mar 22.

    PMID: 34092870BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Serkan Tulgar

    Samsun Üniversitesi tıp fakültesi, Samsun Eğitim ve Araştırma Hastanesi

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 13, 2023

Study Start

January 18, 2023

Primary Completion

May 7, 2024

Study Completion

May 7, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)