Total Knee ArthroplastyNCT07568106
Adductor Canal Block With or Without Biceps Femoris Short Head Block in Total Knee Arthroplasty
A study testing Adductor Canal Block and Biceps Femoris Short Head Block in people with Total Knee Arthroplasty, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Adductor Canal Block and Biceps Femoris Short Head Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to 15 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- Adult patients undergoing unilateral primary TKA
- Planned spinal anesthesia
- Written informed consent
Who cannot join
- Coagulopathy
- Drug allergy
- BMI > 35
- Renal/hepatic failure
- Chronic pain or opioid use
- Depression or psychiatric disorder
Show all 9Show fewer
- Revision or bilateral TKA
- Neurological deficits
- Preoperative ROM < 90°
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Adductor Canal Block, Biceps Femoris Short Head Block, Sham Biceps Femoris Short Head Block
- Keywords
- Total Knee Arthroplasty, Adductor Canal Block, Biceps Femoris Short Head Block, Postoperative Pain, Functional Recovery, Opioid Consumption, Knee Osteoarthritis
- Medical subject headings
- Pain, Postoperative, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor Canal BlockProcedure or surgery
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.
Biceps Femoris Short Head BlockProcedure or surgery
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.
Sham Biceps Femoris Short Head BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| ACB + BiFeS | Experimental | 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. Receives: Procedure: Adductor Canal Block; Procedure: Biceps Femoris Short Head Block |
| ACB + sham BiFeS | Active comparator | Participants receive spinal anesthesia followed by an ultrasound-guided adductor canal block and a sham biceps femoris short head block using normal saline. Receives: Procedure: Adductor Canal Block; Procedure: Sham Biceps Femoris Short Head Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posterior Knee Pain Intensity
Posterior knee pain assessed using the Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates worst imaginable pain.
Measured: 6 hours postoperatively
Secondary outcomes (7)
Postoperative Pain Intensity
Pain intensity at rest and during movement assessed using the Numeric Rating Scale (NRS, 0-10).
Measured: 30 minutes, 1, 6, 12, 24, and 48 hours postoperatively
Total Opioid Consumption
Total opioid consumption measured from patient-controlled analgesia (PCA) device and additional opioid requirements, expressed in milligrams of morphine equivalent.
Measured: 0-48 hours postoperatively
Rescue Analgesic Use
Requirement for additional analgesic medications (e.g., meperidine, paracetamol, ibuprofen) recorded as yes/no and total doses administered.
Measured: 0-48 hours postoperatively
Functional Recovery
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.
Measured: 24 hours, 48 hours, and 6 weeks postoperatively
Quadriceps Muscle Strength
Quadriceps isometric muscle strength measured using a handheld dynamometer and expressed in Nm/kg.
Measured: Preoperatively, 24 hours, 48 hours, and 6 weeks postoperatively
Time to First Ambulation
Time from the end of surgery to first successful ambulation, measured in hours.
Measured: Within 48 hours postoperatively
Patient Satisfaction
Patient satisfaction with postoperative pain management assessed using a 4-point scale (excellent, good, moderate, poor).
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start15 May 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Laflı Tunay, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568106
- Sponsor's protocol ID
- CU-BiFeS-2026
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07568106
- Acronym / sponsor ID
- CU-BiFeS-2026
- Conditions
- Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, Adductor Canal Block, Biceps Femoris Short Head Block, Postoperative Pain, Functional Recovery, Opioid Consumption, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACB + BiFeS | Experimental | Procedure: Adductor Canal Block, Procedure: Biceps Femoris Short Head BlockParticipants receive spinal anesthesia followed by an ultrasound-guided adductor canal block and a biceps femoris short head block using local anesthetic for postoperative analgesia. |
| ACB + sham BiFeS | Active comparator | Procedure: Adductor Canal Block, Procedure: Sham Biceps Femoris Short Head BlockParticipants receive spinal anesthesia followed by an ultrasound-guided adductor canal block and a sham biceps femoris short head block using normal saline. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA I-III
- Adult patients undergoing unilateral primary TKA
- Planned spinal anesthesia
- Written informed consent
Key exclusion criteria (9 listed)
- Coagulopathy
- Drug allergy
- BMI > 35
- Renal/hepatic failure
- Chronic pain or opioid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adductor Canal BlockUltrasound-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. | Procedure or surgery | ACB + BiFeS, ACB + sham BiFeS |
| Biceps Femoris Short Head BlockUltrasound-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. | Procedure or surgery | ACB + BiFeS |
| Sham Biceps Femoris Short Head BlockSham 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. | Procedure or surgery | ACB + sham BiFeS |
Primary outcome
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.
7 secondary outcomes
Postoperative Pain Intensity
Time frame: 30 minutes, 1, 6, 12, 24, and 48 hours postoperatively
Total Opioid Consumption
Time frame: 0-48 hours postoperatively
Rescue Analgesic Use
Time frame: 0-48 hours postoperatively
Functional Recovery
Time frame: 24 hours, 48 hours, and 6 weeks postoperatively
Quadriceps Muscle Strength
Time frame: Preoperatively, 24 hours, 48 hours, and 6 weeks postoperatively
Time to First Ambulation
Time frame: Within 48 hours postoperatively
Patient Satisfaction
Time frame: 48 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adductor Canal Block and Biceps Femoris Short Head Block in people with Total Knee Arthroplasty, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Demet Lafli Tunay, M.D. (+905358685831, dlafli@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posterior Knee Pain Intensity (time frame: 6 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.