- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07233785
Comparison of ACB With ACB and BiFeS Combination in Knee Arthroplasty Surgeries
Comparison of the Postoperative Analgesic Efficacy of the Combination of Adductor Canal Block and Biceps Femoris Short Head Block Versus Adductor Canal Block Alone in Patients Undergoing Total Knee Arthroplasty
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: OĞUZ GÜNDOĞDU
- Phone Number: +905545945469
- Email: droguzgundogdu@gmail.com
Study Contact Backup
- Name: BUĞRA KARATAŞ
- Phone Number: +905412453634
- Email: bugrabgr60@hotmail.com
Study Locations
-
-
Sivas
-
Sivas, Sivas, Turkey (Türkiye), 58140
- Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients over 18 years of age who underwent percutaneous nephrolithotomy under general anesthesia and were I-II-III according to the American Society of Anesthesiologists (ASA) risk classification were included in the study.
Exclusion Criteria:
- patients who did not give consent,
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients using anticoagulants,
- patients with known allergies to any of the study drugs,
- patients with unstable hemodynamics,
- patients who could not cooperate during postoperative pain assessment
- patients who wanted to withdraw from the study,
- patients with alcohol and drug addiction,
- patients with musculoskeletal abnormalitie
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Adductor Canal Block
For an adductor canal block, a high-frequency ultrasound probe will be placed on the anterior aspect of the patient's thigh, approximately at the midpoint between the inguinal crease and the medial condyle of the knee.
(The depth is generally 3-5 cm).
Using an in-plane technique, the needle will be advanced from lateral to medial, passing through the sartorius or vastus medialis muscle, and 20 mL of 0.25% bupivacaine will be injected around the femoral artery.
|
20 mL of 0.25% bupivacaine
|
|
Active Comparator: Combination of Adductor Canal Block and Biceps Femoris Short Head Block
For adductor canal block, a high-frequency ultrasound probe will be placed on the anterior aspect of the patient's thigh, approximately at the midpoint between the inguinal crease and the medial condyle of the knee. (The depth is generally 3-5 cm). Using in-plane technique, the needle passing through the sartorius or vastus medialis muscle, and 20 mL of 0.25% bupivacaine will be injected around the femoral artery. For BiFeS block, a high-frequency ultrasound probe will be placed on the distal posterior aspect of the thigh. The Biceps Femoris Short Head (BiFeS) muscle will be visualized at the distal lateral part of the femur, near the lateral supracondylar line, and the needle tip will be placed at the interface between the BiFeS and the lateral supracondylar line of the femur. 20 mL of 0.25% bupivacaine will be injected, and during the injection, it will be confirmed by ultrasound that the solution lifts the muscle and spreads along the bone surface. |
20 mL of 0.25% bupivacaine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1. Numeric Rating Scale (NRS) Scores
Time Frame: Postoperative 24 hours
|
Numerical rating scale is used for pain assessment.
The scores of the numerical rating scale changes between 0 to 10 points.
10 points mean "the most severe pain that the patient ever had".
0 point means "there is no pain."
Higher scores mean worse outcome.
|
Postoperative 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total tramadol consumption
Time Frame: Postoperative 24 hours
|
Postoperative total analgesic need was recorded as "milligram" in unit.
|
Postoperative 24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: OĞUZ GÜNDOĞDU, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
- Study Chair: BUĞRA KARATAŞ, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
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 (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-09/52
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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Clinical Trials on Adductor Canal Block (ACB) Only
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Ain Shams UniversityCompletedPost Operative Pain ControlEgypt
-
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-
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-
Kanuni Sultan Suleyman Training and Research HospitalCompletedPostoperative Pain ManagementTurkey (Türkiye)
-
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-
Konya Beyhekim Training and Research HospitalNot yet recruitingTotal Knee Arthroplasty | Adductor Canal Block | IPACK Block Multimodal Analgesia | Genicular Nerves Block
-
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-
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-
Ain Shams UniversityRecruitingThe Time Interval Between Injection of the Block and the First Rescue Analgesia Dose Given. Postoperative Pain Assessment Using NRS Score for PainEgypt
-
Ataturk UniversityCompletedANTERIOR CRUCIATE LIGAMENT RECONSTRUCTIONTurkey (Türkiye)