- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06942702
Efficacy of Genicular Block on Total Knee Arthroplasty Surgery
Assesment of Postoperative Analgesic Efficacy of Preoperatively Applied Genicular Block on Total Knee Arthroplasty: A Randomized Controlled Study
The aim of this study is to investigate the postoperative pain relieving effect of preoperative genicular block in total knee arthroplasty surgery. The main questions it aims to answer are:
- Do visual analog scale (VAS) scores decrease in patients who underwent geniculate block?
- Does opioid consumption decrease in patients who underwent geniculate block?
Researchers will compare postoperative pain in patients who received genicular block with those who did not.One group of patients will be administered 0.25% bupivacaine with the geniculate block method. The other group will not undergo any intervention. Both groups will be administered intravenous morphine for postoperative analgesia.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mustafa Azizoglu, Associated Professor
- Phone Number: +90 5325667061
- Email: dryalamaoglu@hotmail.com
Study Contact Backup
- Name: Mervenur Ozturk, Resident Doctor
- Phone Number: +90 5525345189
- Email: mervenurnurozturk@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Scheduled for unilateral and primary total knee arthroplasty
- Older than 18 years of age
Exclusion Criteria:
- Younger than 18 years
- Bilateral knee arthroplasty
- Revision case of knee arthroplasty
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Genicular block group
this group consists of the patients receiving genicular block preoperatively and they will be given morfin with PCA (Patient controlled analgesia) and paracetamol 3x1000 mg intravenous and diclofenac 75 mg intramuscular (if needed)
|
Genicular block is a regional analgesic technique performed with USG
All patients are given paracetamol (3x1000 mg) and diclofenac (if needed)
this group consists of the patients no any intervention preoperatively and they will be given morfin with PCA (Patient controlled analgesia) and paracetamol 3x1000 mg intravenous and diclofenac 75 mg intramuscular (if needed)
Other Names:
|
|
Active Comparator: patients only given PCA-morfin postoperatively
this group consists of the patients given morfin with PCA, paracetamol 3x1000 mg and diclofenac (if needed)
|
All patients are given paracetamol (3x1000 mg) and diclofenac (if needed)
this group consists of the patients no any intervention preoperatively and they will be given morfin with PCA (Patient controlled analgesia) and paracetamol 3x1000 mg intravenous and diclofenac 75 mg intramuscular (if needed)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
opioid consumption
Time Frame: 0-48 hours
|
Morphine consumption is assesed by PCA
|
0-48 hours
|
|
Visual Analog Scale Measure
Time Frame: 0-48 hours
|
VAS scores are assessed at 0th, 24th and 48th hours post operatively VAS score consists of 0-10 in numbers, the bigger the number the worse the pain
|
0-48 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mustafa Azizoglu, Associated Professor, Mersin university Faculty of Medicine, Department of Anesthesiology and Reanimation
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Organic Chemicals
- Investigative Techniques
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Carboxylic Acids
- Anilides
- Amides
- Aniline Compounds
- Amines
- Acetanilides
- Acids, Carbocyclic
- Immunologic Techniques
- Phenylacetates
- Immunologic Tests
- Skin Tests
- Immune System Phenomena
- Antigen-Antibody Reactions
- Acetaminophen
- Diclofenac
- Passive Cutaneous Anaphylaxis
Other Study ID Numbers
- MersinUgenicular
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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