- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07568106
Adductor Canal Block With or Without Biceps Femoris Short Head Block in Total Knee Arthroplasty
Effect of Adding a Biceps Femoris Short Head Block to an Adductor Canal Block on Postoperative Pain and Functional Outcomes After Total Knee Arthroplasty: A Randomized Controlled Trial
Total knee arthroplasty is associated with moderate to severe postoperative pain, which may delay mobilization and recovery. Multimodal analgesia including regional anesthesia techniques is widely used to improve outcomes. The adductor canal block (ACB) provides anteromedial knee analgesia but may not adequately cover the posterolateral region.
The biceps femoris short head (BiFeS) block is a novel motor-sparing regional anesthesia technique targeting the posterolateral capsule of the knee. This randomized controlled trial aims to compare the analgesic efficacy and functional outcomes of ACB combined with BiFeS block versus ACB alone in patients undergoing total knee arthroplasty.
The primary outcome is posterior knee pain at postoperative 6 hours. Secondary outcomes include pain scores within 48 hours, opioid consumption, early and late functional recovery, and opioid-related adverse effects.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Demet Lafli Tunay, M.D.
- Phone Number: +905358685831
- Email: dlafli@yahoo.com
Study Locations
-
-
Saricam
-
Adana, Saricam, Turkey (Türkiye), 01330
- Çukurova University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ASA I-III
- Adult patients undergoing unilateral primary TKA
- Planned spinal anesthesia
- Written informed consent
Exclusion Criteria:
- Coagulopathy
- Drug allergy
- BMI > 35
- Renal/hepatic failure
- Chronic pain or opioid use
- Depression or psychiatric disorder
- Revision or bilateral TKA
- Neurological deficits
- Preoperative ROM < 90°
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ACB + BiFeS
Participants receive spinal anesthesia followed by an ultrasound-guided adductor canal block and a biceps femoris short head block using local anesthetic for postoperative analgesia.
|
Ultrasound-guided adductor canal block performed with injection of local anesthetic into the adductor canal to block the saphenous nerve and provide postoperative analgesia following total knee arthroplasty.
Ultrasound-guided biceps femoris short head block performed with injection of local anesthetic between the biceps femoris short head and femur to target the posterolateral innervation of the knee for postoperative analgesia.
|
|
Active Comparator: ACB + sham BiFeS
Participants receive spinal anesthesia followed by an ultrasound-guided adductor canal block and a sham biceps femoris short head block using normal saline.
|
Ultrasound-guided adductor canal block performed with injection of local anesthetic into the adductor canal to block the saphenous nerve and provide postoperative analgesia following total knee arthroplasty.
Sham ultrasound-guided biceps femoris short head block performed with injection of normal saline at the same anatomical location to maintain blinding without providing active analgesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Posterior Knee Pain Intensity
Time Frame: 6 hours postoperatively
|
Posterior knee pain assessed using the Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates worst imaginable pain.
|
6 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Intensity
Time Frame: 30 minutes, 1, 6, 12, 24, and 48 hours postoperatively
|
Pain intensity at rest and during movement assessed using the Numeric Rating Scale (NRS, 0-10).
|
30 minutes, 1, 6, 12, 24, and 48 hours postoperatively
|
|
Total Opioid Consumption
Time Frame: 0-48 hours postoperatively
|
Total opioid consumption measured from patient-controlled analgesia (PCA) device and additional opioid requirements, expressed in milligrams of morphine equivalent.
|
0-48 hours postoperatively
|
|
Rescue Analgesic Use
Time Frame: 0-48 hours postoperatively
|
Requirement for additional analgesic medications (e.g., meperidine, paracetamol, ibuprofen) recorded as yes/no and total doses administered.
|
0-48 hours postoperatively
|
|
Functional Recovery
Time Frame: 24 hours, 48 hours, and 6 weeks postoperatively
|
Functional recovery assessed by range of motion (ROM), quadriceps muscle strength, time to first ambulation, ability to walk 10 meters without assistance, and performance on the 5-times sit-to-stand test.
|
24 hours, 48 hours, and 6 weeks postoperatively
|
|
Quadriceps Muscle Strength
Time Frame: Preoperatively, 24 hours, 48 hours, and 6 weeks postoperatively
|
Quadriceps isometric muscle strength measured using a handheld dynamometer and expressed in Nm/kg.
|
Preoperatively, 24 hours, 48 hours, and 6 weeks postoperatively
|
|
Time to First Ambulation
Time Frame: Within 48 hours postoperatively
|
Time from the end of surgery to first successful ambulation, measured in hours.
|
Within 48 hours postoperatively
|
|
Patient Satisfaction
Time Frame: 48 hours postoperatively
|
Patient satisfaction with postoperative pain management assessed using a 4-point scale (excellent, good, moderate, poor).
|
48 hours postoperatively
|
Collaborators and Investigators
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CU-BiFeS-2026
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
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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