- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07242339
Comparison of the Analgesic Efficacy of Adductor Canal Block Versus Adductor Canal Plus Biceps Femoris Short Head Block in Patients Undergoing Knee Arthroscopy (bifes knee)
Comparison of the Analgesic Efficacy of Adductor Canal Block Versus Adductor Canal Plus Biceps Femoris Short Head Block in Patients Undergoing Knee Arthroscopy: A Prospective Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Knee arthroscopy is one of the most common orthopedic procedures and is frequently associated with significant postoperative pain. Effective multimodal analgesia is therefore essential to reduce opioid consumption, improve early mobilization, and enhance overall patient recovery. Among the regional anesthesia techniques, the adductor canal block (ACB) is well established as an effective motor-sparing block that provides analgesia to the medial and anterior aspects of the knee. However, patients often continue to experience posterolateral knee pain, which is not consistently relieved by ACB alone.
Recent anatomical and cadaveric studies have described the biceps femoris short head (BiFeS) block as a promising technique for targeting the posterolateral knee compartment. The BiFeS block involves deposition of local anesthetic between the short head of the biceps femoris muscle and the lateral femoral cortex at the supracondylar level. Preliminary findings suggest that this block may provide effective analgesia for the posterolateral knee without causing significant motor impairment.
This prospective, randomized, controlled, multicenter clinical trial is designed to evaluate whether the addition of the BiFeS block to standard ACB improves postoperative analgesia compared with ACB alone in patients undergoing knee arthroscopy under spinal anesthesia. The study will investigate pain scores at rest and during movement, total opioid consumption, side effects, rescue analgesic requirements, and quality of recovery. The dermatomal distribution of the blocks will be optionally assessed using cold testing.
By directly comparing ACB and combined ACB+BiFeS block under standardized perioperative conditions, this study seeks to generate high-quality evidence on the clinical utility of BiFeS as an adjunct technique. The results are expected to guide anesthesiologists in selecting optimal regional analgesia strategies for knee arthroscopy, with the potential to improve patient satisfaction, reduce opioid-related complications, and shorten hospitalization.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
küçükçekmece
-
Istanbul, küçükçekmece, Turkey (Türkiye), 34303
- Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years
- ASA physical status I-III
- Scheduled for elective knee arthroscopy under spinal anesthesia
- Ability to provide written informed consent
Exclusion Criteria:
- Coagulopathy or bleeding diathesis
- Current use of anticoagulant therapy
- Known allergy or contraindication to local anesthetics used in the study
- History of diabetes mellitus with neuropathy or other neuropathic disorders
- Contraindications to regional anesthesia techniques
- Refusal to participate
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: Adductor Canal Block (ACB)
Participants will undergo ultrasound-guided adductor canal block at the end of surgery under spinal anesthesia.
|
Ultrasound-guided injection of 10 mL 0.25% bupivacaine into the adductor canal targeting the femoral artery region, providing motor-sparing analgesia to the medial/anterior knee.
|
|
Active Comparator: Adductor Canal Block + Biceps Femoris Short Head Block (ACB+BiFeS)
Participants will undergo both adductor canal block and biceps femoris short head block at the end of surgery under spinal anesthesia.
|
Combination of adductor canal block (10 mL 0.25% bupivacaine) and biceps femoris short head block with 25 mL 0.25% bupivacaine, deposited at the interfascial plane between BiFeS muscle and lateral femoral cortex to extend analgesia to the posterolateral knee.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Opioid Consumption (Tramadol, mg)
Time Frame: 24 hours
|
The total dose of tramadol administered via intravenous patient-controlled analgesia (PCA) device within the first 24 hours postoperatively will be recorded in milligrams.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain with Movement and at rest (NRS)
Time Frame: At 0, 6, 12, and 24 hours after surgery
|
Pain intensity during knee movement will be assessed using the Numerical Rating Scale (0-10).
|
At 0, 6, 12, and 24 hours after surgery
|
|
Rescue Analgesia Requirement
Time Frame: Within the first 24 hours postoperatively
|
The number of patients requiring rescue analgesia (IV dexketoprofen 50 mg) will be recorded.
|
Within the first 24 hours postoperatively
|
|
Incidence of Nausea and Vomiting
Time Frame: Within the first 24 hours postoperatively
|
Presence of nausea/vomiting and the requirement for antiemetic medications will be documented.
|
Within the first 24 hours postoperatively
|
|
Dermatomal Spread of Block
Time Frame: 2nd hour postoperatively
|
Sensory block distribution will be assessed using a cold test to map dermatomal coverage.
|
2nd hour postoperatively
|
|
Motor Blockade Incidence
Time Frame: Within the first 24 hours postoperatively
|
Patients will be evaluated for presence or absence of motor weakness attributable to the block.
|
Within the first 24 hours postoperatively
|
|
Quality of Recovery (QOR-15 score)
Time Frame: At 24 hours after surgery
|
Patient recovery quality will be assessed using the validated Quality of Recovery 15-item questionnaire (QOR-15). The scale includes 15 items, each scored from 0 to 10, producing a total score ranging from 0 to 150. Minimum score: 0 (poor recovery) Maximum score: 150 (excellent recovery) Interpretation: Higher scores indicate better postoperative recovery. |
At 24 hours after surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Engin ihsan Turan, Specialist, Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bifes knee
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.
Clinical Trials on Postoperative Pain Management
-
Elazıg Fethi Sekin Sehir HastanesiNot yet recruiting
-
Zagazig UniversityCompletedPostoperative Pain ManagementEgypt
-
University of California, Los AngelesNot yet recruitingPostoperative Pain Management
-
Aydin Adnan Menderes UniversityCompleted
-
Zagazig UniversityNot yet recruitingPostoperative Pain Management | Postoperative Analgesia
-
Rhode Island HospitalRecruitingPostoperative Pain ManagementUnited States
-
Haisco Pharmaceutical Group Co., Ltd.RecruitingPostoperative Pain ManagementChina
-
Shenyang Sixth People's HospitalWithdrawnPostoperative Pain ManagementChina
-
Haisco Pharmaceutical Group Co., Ltd.CompletedPostoperative Pain ManagementChina
-
Yeditepe University HospitalCompletedPain Management | Breast Augmentation | Pain Management After Surgery | Pain Management in Postoperative CareTurkey
Clinical Trials on Adductor Canal Block (ACB) Only
-
Ain Shams UniversityCompletedPost Operative Pain ControlEgypt
-
Fayoum University HospitalNot yet recruiting
-
Medical University of South CarolinaCompleted
-
Ain Shams UniversityNot yet recruitingFunctional Recovery | Adductor Canal Block | Total Knee Replacement Surgery
-
Konya Beyhekim Training and Research HospitalNot yet recruitingTotal Knee Arthroplasty | Adductor Canal Block | IPACK Block Multimodal Analgesia | Genicular Nerves Block
-
Ankara Etlik City HospitalEnrolling by invitationTotal Knee Arthroplasty for GonarthrosisTurkey (Türkiye)
-
Kafrelsheikh UniversityNot yet recruitingPostoperative Analgesia | Morphine and Dexmedetomidine
-
Cumhuriyet UniversityNot yet recruitingKnee Arthroplasty, Total | Knee Surgery | Postoperative Pain ManagementTurkey (Türkiye)
-
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)