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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05684471
Other study ID # LINRA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 18, 2023
Est. completion date May 7, 2024

Study information

Verified date May 2024
Source Samsun University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date May 7, 2024
Est. primary completion date May 7, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Turkey Samsun University Samsun

Sponsors (1)

Lead Sponsor Collaborator
Samsun University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cumulative opioid comsumption Morphine consumptions for both group will be recorded up to 24 hour
Secondary Numeric rating scale for postoperative pain intensity 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
Secondary Quality of Recovery (QoR-15) 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
Secondary Presence of quadriceps motor block (defined as paralysis or paresis). 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
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