- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06357013
Postoperative Analgesia in Bilateral Knee Arthroplasties
January 12, 2025 updated by: Merve Yazici Kara, Kocaeli City Hospital
Postoperative Analgesia in Bilateral Knee Arthroplasties:Suprainguinal Fascia Iliaca Compartment Block and Local Infiltration Analgesia
To observationally compare the analgesic efficacy of LIA and S-FICB techniques and to record the pain scores of patients who underwent bilateral knee operations in the postoperative period.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kocaeli, Turkey
- Kocaeli City Hospital
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients aged 18-75 years, who planned elective bilateral knee arthroplasty under spinal anesthesia, American Society of Anesthesiologists (ASA) risk score I-II.
Description
Inclusion Criteria:
- Planned elective bilateral knee arthroplasty under spinal anesthesia
- American Society of Anesthesiologists (ASA) risk score I-II
- Patients aged 18-75 years
Exclusion Criteria:
- Those receiving general anesthesia,
- Those with epidural catheters,
- Those who refused to participate in the study,
- Those whose spinal anesthesia failed and returned to general anesthesia,
- Those with a body mass index (BMI) >30 kg/m2,
- History of chronic opioid or corticosteroid use,
- Patients with psychiatric or neurological problems that would not allow assessment of pain using a visual analog scale (VAS) will be excluded.
- In addition, patients whose surgery lasted <40 minutes or >120 minutes will also be excluded to keep the data homogeneous.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Grup-1: Suprainguinal fascia iliaca compartment block
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Suprainguinal fascia iliaca compartment block (S-FICB) is one of the commonly used regional analgesia techniques for postoperative analgesia in lower extremity surgeries.
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Grup-2: Local infiltration analgesia
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Local infiltration analgesia is applied to the posterior part of the knee, including the periosteum, ligaments, muscle and/or skin area before closing the surgical field.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Suprainguinal fascia iliaca compartment block (S-FICB) produces adequate analgesic effect in knee arthroplasty.
Time Frame: 4 months
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The aim of this study was to observationally compare the analgesic efficacy of local infiltration analgesia (LIA) and suprainguinal fascia iliaca compartment block (S-FICB) techniques in patients who underwent bilateral knee operations.
Postoperative pain follow-up of the patients will be done by recording Visual analog scales (VAS) at 4, 8, 12 and 24 hours.
Additional analgesic needs and unwanted side effects will also be recorded.
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4 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Merve Yazici Kara, MD, Kocaeli City Hospital
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 1, 2024
Primary Completion (Actual)
May 1, 2024
Study Completion (Actual)
June 30, 2024
Study Registration Dates
First Submitted
March 14, 2024
First Submitted That Met QC Criteria
April 4, 2024
First Posted (Actual)
April 10, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 12, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-40
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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