Postoperative Pain Following Knee ArthroplastyBiFeS AdductorNCT07577869
Biceps Femoris Short Head (BiFeS) Block and Adductor Canal Block for Postoperative Analgesia Following Total Knee Arthroplasty
A study testing Procedure: Biceps Femoris Short Head Block and Procedure: Spinal Anesthesia in people with Postoperative Pain Following Knee Arthroplasty and Total Knee Arthroplasty, run by Ömer Kayar at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized controlled study aims to evaluate the effect of ultrasound-guided Biceps Femoris Short Head (BiFeS) block combined with adductor canal block on postoperative opioid consumption and pain control in patients undergoing elective total knee arthroplasty under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain Following Knee Arthroplasty, Total Knee Arthroplasty
- What is being tested?
- Procedure: Biceps Femoris Short Head Block and Procedure: Spinal Anesthesia
- 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
- 2 Jun 2026to 2 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 and older
- ASA I-III
- Patients scheduled for elective unilateral knee replacement
- Eligibility for and consent to spinal anesthesia
Who cannot join
- History of allergy or anaphylaxis to local anesthetics, animal gelatin, or chlorhexidine
- Bleeding diathesis/inability to discontinue anticoagulants
- Infection (at the injection site/sepsis)
- Neurological disorders or cognitive impairment affecting pain perception
- Pregnancy, breastfeeding
- Patients under 18 years of age
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, 1 recruiting
- Recruiting
Kayseri City Hospital
Kayseri, Kocasinan, 38080
About this study
Official title: A Comparison of the Effects of Biceps Femoris Short Head Block and Adductor Canal Block in Total Knee Arthroplasty on Postoperative Analgesia Using Multimodal Analgesia Methods
This prospective randomized controlled study aims to evaluate the effect of ultrasound-guided Biceps Femoris Short Head (BiFeS) block combined with adductor canal block on postoperative opioid consumption and pain control in patients undergoing elective total knee arthroplasty under spinal anesthesia.
A total of 60 patients aged 18-80 years with ASA physical status I-III scheduled for unilateral elective total knee arthroplasty will be randomized into two groups. The intervention group will receive spinal anesthesia followed by BiFeS block and adductor canal block before surgery, in addition to standard multimodal analgesia and postoperative morphine patient-controlled analgesia (PCA). The control group will receive spinal anesthesia and standard multimodal analgesia with postoperative morphine PCA without peripheral nerve block.
The primary outcome is total morphine consumption during the first 24 postoperative hours. Secondary outcomes include postoperative pain scores assessed by Numeric Rating Scale (NRS), time to first analgesic requirement, time to first foot movement, and Quality of Recovery-15 (QoR-15) scores.
Read the detailed description
Total knee arthroplasty is associated with significant postoperative pain and high opioid consumption. Peripheral nerve blocks are increasingly used as part of multimodal analgesia strategies to reduce opioid requirements and improve postoperative recovery.
This prospective, randomized, single-center clinical study will be conducted at Kayseri City Hospital Department of Anesthesiology and Reanimation. Sixty adult patients undergoing elective unilateral total knee arthroplasty under spinal anesthesia will be enrolled after written informed consent.
Participants will be randomized into two groups using the closed envelope method.
Intervention Group (n=30):
Patients will receive spinal anesthesia with 3.5-4 mL 0.5% hyperbaric bupivacaine. Before surgical incision, ultrasound-guided BiFeS block will be performed using 25 mL of 0.25% bupivacaine, followed by ultrasound-guided adductor canal block using 15 mL of 0.25% bupivacaine.
Control Group (n=30):
Patients will receive spinal anesthesia only without peripheral nerve block.
All patients will receive standard multimodal analgesia including intravenous paracetamol 1 g every 8 hours and intravenous dexketoprofen 50 mg every 12 hours. Postoperative analgesia will be provided using morphine PCA prepared as 1 mg/mL concentration with 15-minute lockout interval and maximum 4 boluses per hour.
Rescue analgesia will be administered as intravenous fentanyl 25 mcg in patients with NRS score ≥4 despite PCA use.
Primary outcome measure is total morphine consumption during the first 24 postoperative hours.
Secondary outcome measures include Numeric Rating Scale pain scores at postoperative 1, 6, 12, and 24 hours, time to first analgesic requirement, time to first active foot movement, rescue analgesic requirement, and postoperative Quality of Recovery-15 scores.
The study hypothesis is that combined BiFeS and adductor canal block will reduce postoperative opioid consumption and improve recovery quality compared with standard multimodal analgesia alone.
- Being tested
- Procedure: Biceps Femoris Short Head Block, Procedure: Spinal Anesthesia
- Keywords
- Postoperative Pain, BiFeS, BiFeS and Adductor Canal Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: Biceps Femoris Short Head BlockProcedure or surgery
Also called Procedure: Adductor Canal Block, Drug: Morphine PCA, Drug: Paracetamol, Drug: Dexketoprofen
Patients will receive spinal anesthesia followed by ultrasound-guided Biceps Femoris Short Head (BiFeS) block using 25 mL of 0.25% bupivacaine and adductor canal block using 15 mL of 0.25% bupivacaine before surgery. Standard multimodal analgesia will be provided using intravenous paracetamol and dexketoprofen, along with postoperative patient-controlled analgesia with morphine for 24 hours.
Procedure: Spinal AnesthesiaProcedure or surgery
Also called Drug: Morphine PCA, Drug: Paracetamol, Drug: Dexketoprofen, Drug:Fentanyl
Patients will receive spinal anesthesia without peripheral nerve block. Standard multimodal analgesia will be provided using intravenous paracetamol and dexketoprofen, along with postoperative patient-controlled analgesia with morphine for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Block Group | Experimental | Patients receive spinal anesthesia followed by ultrasound-guided BiFeS block and adductor canal block before surgery, plus standard multimodal analgesia and morphine PCA. Receives: Procedure: Procedure: Biceps Femoris Short Head Block |
| Multimodal Analgesia Group | Active comparator | Patients receive spinal anesthesia only, followed by standard multimodal analgesia and morphine PCA. Receives: Procedure: Procedure: Spinal Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Morphine Consumption in 24 Hours
Total cumulative morphine consumption measured from patient-controlled analgesia device during the first 24 postoperative hours.
Measured: Within the first 24 hours after surgery
Secondary outcomes (4)
Numeric Rating Scale (NRS) Pain Scores
Pain intensity measured using NRS at rest (0-10 scale).
Measured: Postoperative 1, 6, 12, and 24 hours
Time to First Analgesic Requirement
Time from end of surgery to first patient-reported pain requiring analgesic medication.
Measured: 24 hours
Time to First Foot Movement
Time from completion of surgery to first active foot movement.
Measured: 24 hours
QoR-15 Score
Postoperative quality of recovery will be assessed using the validated 15-item Quality of Recovery questionnaire (QoR-15), which evaluates patient well-being, physical comfort, emotional state, psychological support, and pain. Total scores range from 0 to 150, with higher scores indicating better postoperative recovery.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start2 Jun 2026
- Primary completion2 Jun 2027 (estimated)
- Study completion2 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain Following Knee ArthroplastyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ömer Kayar
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Ömer Kayar, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577869
- Sponsor's protocol ID
- KSH-ANES-2026/77
- Acronym
- BiFeS Adductor
- Status last verified
- Jun 2026
- First submitted
- 5 May 2026
- Last updated
- 12 Jun 2026
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effects of Biceps Femoris Short Head Block and Adductor Canal Block in Total Knee Arthroplasty on Postoperative Analgesia Using Multimodal Analgesia Methods
- ClinicalTrials.gov ID
- NCT07577869
- Acronym / sponsor ID
- BiFeS Adductor / KSH-ANES-2026/77
- Keywords
- Postoperative Pain, BiFeS, BiFeS and Adductor Canal Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ömer KayarOther government
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 2 Jun 2027 (estimated)
- Study completion
- 2 Jul 2027 (estimated)
- First posted
- 11 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.
This prospective randomized controlled study aims to evaluate the effect of ultrasound-guided Biceps Femoris Short Head (BiFeS) block combined with adductor canal block on postoperative opioid consumption and pain control in patients undergoing elective total knee arthroplasty under spinal anesthesia.
A total of 60 patients aged 18-80 years with ASA physical status I-III scheduled for unilateral elective total knee arthroplasty will be randomized into two groups. The intervention group will receive spinal anesthesia followed by BiFeS block and adductor canal block before surgery, in addition to standard multimodal analgesia and postoperative morphine patient-controlled analgesia (PCA). The control group will receive spinal anesthesia and standard multimodal analgesia with postoperative morphine PCA without peripheral nerve block.
The primary outcome is total morphine consumption during the first 24 postoperative hours. Secondary outcomes include postoperative pain scores assessed by Numeric Rating Scale (NRS), time to first analgesic requirement, time to first foot movement, and Quality of Recovery-15 (QoR-15) scores.
Detailed description
Total knee arthroplasty is associated with significant postoperative pain and high opioid consumption. Peripheral nerve blocks are increasingly used as part of multimodal analgesia strategies to reduce opioid requirements and improve postoperative recovery.
This prospective, randomized, single-center clinical study will be conducted at Kayseri City Hospital Department of Anesthesiology and Reanimation. Sixty adult patients undergoing elective unilateral total knee arthroplasty under spinal anesthesia will be enrolled after written informed consent.
Participants will be randomized into two groups using the closed envelope method.
Intervention Group (n=30):
Patients will receive spinal anesthesia with 3.5-4 mL 0.5% hyperbaric bupivacaine. Before surgical incision, ultrasound-guided BiFeS block will be performed using 25 mL of 0.25% bupivacaine, followed by ultrasound-guided adductor canal block using 15 mL of 0.25% bupivacaine.
Control Group (n=30):
Patients will receive spinal anesthesia only without peripheral nerve block.
All patients will receive standard multimodal analgesia including intravenous paracetamol 1 g every 8 hours and intravenous dexketoprofen 50 mg every 12 hours. Postoperative analgesia will be provided using morphine PCA prepared as 1 mg/mL concentration with 15-minute lockout interval and maximum 4 boluses per hour.
Rescue analgesia will be administered as intravenous fentanyl 25 mcg in patients with NRS score ≥4 despite PCA use.
Primary outcome measure is total morphine consumption during the first 24 postoperative hours.
Secondary outcome measures include Numeric Rating Scale pain scores at postoperative 1, 6, 12, and 24 hours, time to first analgesic requirement, time to first active foot movement, rescue analgesic requirement, and postoperative Quality of Recovery-15 scores.
The study hypothesis is that combined BiFeS and adductor canal block will reduce postoperative opioid consumption and improve recovery quality compared with standard multimodal analgesia alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block Group | Experimental | Procedure: Procedure: Biceps Femoris Short Head BlockPatients receive spinal anesthesia followed by ultrasound-guided BiFeS block and adductor canal block before surgery, plus standard multimodal analgesia and morphine PCA. |
| Multimodal Analgesia Group | Active comparator | Procedure: Procedure: Spinal AnesthesiaPatients receive spinal anesthesia only, followed by standard multimodal analgesia and morphine PCA. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 and older
- ASA I-III
- Patients scheduled for elective unilateral knee replacement
- Eligibility for and consent to spinal anesthesia
Key exclusion criteria (6 listed)
- History of allergy or anaphylaxis to local anesthetics, animal gelatin, or chlorhexidine
- Bleeding diathesis/inability to discontinue anticoagulants
- Infection (at the injection site/sepsis)
- Neurological disorders or cognitive impairment affecting pain perception
- Pregnancy, breastfeeding
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 |
|---|---|---|
| Procedure: Biceps Femoris Short Head BlockAlso: Procedure: Adductor Canal Block, Drug: Morphine PCA, Drug: Paracetamol, Drug: DexketoprofenPatients will receive spinal anesthesia followed by ultrasound-guided Biceps Femoris Short Head (BiFeS) block using 25 mL of 0.25% bupivacaine and adductor canal block using 15 mL of 0.25% bupivacaine before surgery. Standard multimodal analgesia will be provided using intravenous paracetamol and dexketoprofen, along with postoperative patient-controlled analgesia with morphine for 24 hours. | Procedure or surgery | Block Group |
| Procedure: Spinal AnesthesiaAlso: Drug: Morphine PCA, Drug: Paracetamol, Drug: Dexketoprofen, Drug:FentanylPatients will receive spinal anesthesia without peripheral nerve block. Standard multimodal analgesia will be provided using intravenous paracetamol and dexketoprofen, along with postoperative patient-controlled analgesia with morphine for 24 hours. | Procedure or surgery | Multimodal Analgesia Group |
Primary outcome
Total Morphine Consumption in 24 Hours
Time frame: Within the first 24 hours after surgery
Total cumulative morphine consumption measured from patient-controlled analgesia device during the first 24 postoperative hours.
4 secondary outcomes
Numeric Rating Scale (NRS) Pain Scores
Time frame: Postoperative 1, 6, 12, and 24 hours
Time to First Analgesic Requirement
Time frame: 24 hours
Time to First Foot Movement
Time frame: 24 hours
QoR-15 Score
Time frame: 24 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 12 Jun 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: Biceps Femoris Short Head Block and Procedure: Spinal Anesthesia in people with Postoperative Pain Following Knee Arthroplasty and Total Knee Arthroplasty, run by Ömer Kayar 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 6 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: looking for participants now, as of the sponsor's last update on 12 Jun 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 Omer Kayar, Medicinae Doctor (+90 531 578 90 37, dr.omer.kayar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Morphine Consumption in 24 Hours (time frame: Within the first 24 hours after surgery). 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 12 Jun 2026.