Postoperative Pain ManagementNCT07233785
Comparison of ACB With ACB and BiFeS Combination in Knee Arthroplasty Surgeries
A study testing Adductor Canal Block (ACB) Only and Adductor Canal Block (ACB) + Biceps Femoris Short Head Block (BiFeS) in people with Postoperative Pain Management and Knee Surgery, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
The aim is to compare the postoperative analgesic effects of Adductor Canal and Biceps Femoris Short Head Blocks with Adductor Canal Block in patients undergoing Knee Arthroplasty surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain Management, Knee Surgery, Knee Arthroplasty, Total
- What is being tested?
- Adductor Canal Block (ACB) Only and Adductor Canal Block (ACB) + Biceps Femoris Short Head Block (BiFeS)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2025to 25 Nov 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
Sivas, Sivas, 58140
About this study
Official title: 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
The aim is to compare the postoperative analgesic effects of Adductor Canal and Biceps Femoris Short Head Blocks with Adductor Canal Block in patients undergoing Knee Arthroplasty surgery
Read the detailed description
Patients were divided into two randomized groups: Group 1 (ACB group, n=30) and Group 2 (ACB+BiFeS group, n=30). All patients will receive the same standard spinal anesthesia per hospital protocol. All blocks will be applied with the same ultrasonography and block equipment, and by the same physician. After the surgery, patients in Group 1 will receive Adductor Canal Block (ACB) with 20 mL of 0.25% bupivacaine. Patients in Group 2 will receive Adductor Canal Block with 20 mL of 0.25% bupivacaine and Biceps Femoris Short Head (BiFeS) with 20 mL of 0.25% bupivacaine. Routine analgesic procedure consisting of 3x400mg Ibuprofen will be followed postoperatively for 24 hours. Numeric Rating Scale (NRS) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hours after the surgery. Tramadol 1mg/kg IV will be administered as a rescue analgesic for all patients if NRS score is higher than 4. Total Tramadol consumption will be calculated.
- Being tested
- Adductor Canal Block (ACB) Only, Adductor Canal Block (ACB) + Biceps Femoris Short Head Block (BiFeS)
- Keywords
- postoperative pain, knee arthroplasty, biceps femoris short head, bifes, adductor canal blok, regional anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor Canal Block (ACB) OnlyProcedure or surgery
20 mL of 0.25% bupivacaine
Adductor Canal Block (ACB) + Biceps Femoris Short Head Block (BiFeS)Procedure or surgery
20 mL of 0.25% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Adductor Canal Block | Active comparator | 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. Receives: Procedure: Adductor Canal Block (ACB) Only |
| Combination of Adductor Canal Block and Biceps Femoris Short Head Block | Active comparator | 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. Receives: Procedure: Adductor Canal Block (ACB) + Biceps Femoris Short Head Block (BiFeS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Numeric Rating Scale (NRS) Scores
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.
Measured: Postoperative 24 hours
Secondary outcomes (1)
Total tramadol consumption
Postoperative total analgesic need was recorded as "milligram" in unit.
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start20 Nov 2025 (estimated)
- Primary completion25 Oct 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ManagementStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oguz Gundogdu, Cumhuriyet University
- Investigators
- OĞUZ GÜNDOĞDU, Principal investigator, Sivas Cumhuriyet University School of Medicine, Anesthesiology and ReanimationBUĞRA KARATAŞ, Study chair, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233785
- Sponsor's protocol ID
- 2025-09/52
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07233785
- Acronym / sponsor ID
- 2025-09/52
- Keywords
- postoperative pain, knee arthroplasty, biceps femoris short head, bifes, adductor canal blok, regional anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 20 Nov 2025 (estimated)
- Primary completion
- 25 Oct 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 18 Nov 2025 (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.
The aim is to compare the postoperative analgesic effects of Adductor Canal and Biceps Femoris Short Head Blocks with Adductor Canal Block in patients undergoing Knee Arthroplasty surgery
Detailed description
Patients were divided into two randomized groups: Group 1 (ACB group, n=30) and Group 2 (ACB+BiFeS group, n=30). All patients will receive the same standard spinal anesthesia per hospital protocol. All blocks will be applied with the same ultrasonography and block equipment, and by the same physician. After the surgery, patients in Group 1 will receive Adductor Canal Block (ACB) with 20 mL of 0.25% bupivacaine. Patients in Group 2 will receive Adductor Canal Block with 20 mL of 0.25% bupivacaine and Biceps Femoris Short Head (BiFeS) with 20 mL of 0.25% bupivacaine. Routine analgesic procedure consisting of 3x400mg Ibuprofen will be followed postoperatively for 24 hours. Numeric Rating Scale (NRS) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hours after the surgery. Tramadol 1mg/kg IV will be administered as a rescue analgesic for all patients if NRS score is higher than 4. Total Tramadol consumption will be calculated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor Canal Block | Active comparator | Procedure: Adductor Canal Block (ACB) OnlyFor 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. |
| Combination of Adductor Canal Block and Biceps Femoris Short Head Block | Active comparator | Procedure: Adductor Canal Block (ACB) + Biceps Femoris Short Head Block (BiFeS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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,
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 Block (ACB) Only20 mL of 0.25% bupivacaine | Procedure or surgery | Adductor Canal Block |
| Adductor Canal Block (ACB) + Biceps Femoris Short Head Block (BiFeS)20 mL of 0.25% bupivacaine | Procedure or surgery | Combination of Adductor Canal Block and Biceps Femoris Short Head Block |
Primary outcome
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.
1 secondary outcome
Total tramadol consumption
Time frame: Postoperative 24 hours
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 25 Nov 2025.
- Individual participant dataSharing planned: No
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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.
OĞUZ GÜNDOĞDU principal investigator
Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
BUĞRA KARATAŞ study chair
Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
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 (ACB) Only and Adductor Canal Block (ACB) + Biceps Femoris Short Head Block (BiFeS) in people with Postoperative Pain Management and Knee Surgery, run by Cumhuriyet 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 1 inclusion and 10 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 25 Nov 2025. 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 OĞUZ GÜNDOĞDU (+905545945469, droguzgundogdu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Numeric Rating Scale (NRS) Scores (time frame: Postoperative 24 hours). 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 25 Nov 2025.