Suprainguinal Fascia Iliaca Block in Knee Arthroplasty
Effect of Supra-inguinal Fascia Iliaca Block on Recovery and Recovery Quality After Total Knee Arthroplasty: A Multicenter, Prospective Randomized Controlled, Double-blind Study.
1 other identifier
interventional
60
1 country
1
Brief Summary
Total knee arthroplasty is the most commonly performed orthopedic surgery, especially in patients with advanced gonarthrosis and limited joint movement. After total knee arthroplasty, patients experience unbearably severe pain. Pain that is not adequately treated in the postoperative period increases the stress response in patients, increases the risk of embolism, causes bleeding in the surgical area, and causes undesirable conditions such as agitation and delirium in patients. This postoperative pain is successfully treated with various variants of multimodal analgesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2024
CompletedFirst Posted
Study publicly available on registry
April 26, 2024
CompletedStudy Start
First participant enrolled
June 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2024
CompletedAugust 6, 2024
August 1, 2024
2 months
April 15, 2024
August 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
quality of recovery-15T
Quality of recovery-15T scores, which show the quality of recovery of the patients, will be recorded at the 24th hour after the surgery. Quality of recovery-15T (0-150, 0= lowest degree of satisfaction, 150= highest degree of satisfaction).
One day
Study Arms (2)
control group
OTHERsuprainguinal fascia iliaca block
ACTIVE COMPARATORInterventions
All patients will be given 1 gram of paracetamol intravenously + 20 milligrams of tenoxicam + 8 milligrams of decort intravenously. Paracetamol 3x1 gram + tenoxicam 2x20 milligrams will continue to be administered. Patients in the control group will be given 40 milliliters of physiological saline during the suprainguinal fascia iliaca block.
All patients will be given 1 gram of paracetamol intravenously + 20 milligrams of tenoxicam + 8 milligrams of decort intravenously. Paracetamol 3x1 gram + tenoxicam 2x20 milligrams will continue to be administered. Patients in the sfıb group will be given 40 milliliters of 0.25 % bupivacaine during the suprainguinal fascia iliaca block.
Eligibility Criteria
You may qualify if:
- Patients who will undergo unilateral total knee arthroplasty
- Patients who will undergo spinal anesthesia
- Patients aged 18-65 years, ASA I-III
- Patients who will stay in the hospital for at least 24 hours
You may not qualify if:
- Patients who do not want to give consent
- Patients who do not want spinal anesthesia
- Patients for whom regional anesthesia is contraindicated
- Patients with confusion
- Patients with coagulopathy
- Patients using anticoagulants
- Patients with infection in the area to be treated
- Those who are allergic to local anesthesia
- Emergency cases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Konya City Hospital
Konya, 42020, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist, Department of Anesthesiology, Konya City Hospital, M.D
Study Record Dates
First Submitted
April 15, 2024
First Posted
April 26, 2024
Study Start
June 6, 2024
Primary Completion
August 1, 2024
Study Completion
August 3, 2024
Last Updated
August 6, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share