Total Knee AnthroplastyNCT06942702
Efficacy of Genicular Block on Total Knee Arthroplasty Surgery
A study testing Genicular blocks (bupivakain) and Paracetamol (acetaminophen)+diclofenac in people with Total Knee Anthroplasty and Genicular Nerves Block, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, double-blind, placebo-controlled trial evaluated the analgesic efficacy of preoperative ultrasound-guided genicular nerve block (GNB) in patients undergoing total knee arthroplasty. A total of 64 patients were randomly assigned to two groups (32 patients per group). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Anthroplasty, Genicular Nerves Block
- What is being tested?
- Genicular blocks (bupivakain) and Paracetamol (acetaminophen)+diclofenac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 15 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Scheduled for unilateral and primary total knee arthroplasty
- Older than 18 years of age
Who cannot join
- Younger than 18 years
- Bilateral knee arthroplasty
- Revision case of knee arthroplasty
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mersin University Hospital
Mersin, Mersin, 33120
About this study
Official title: Assesment of Postoperative Analgesic Efficacy of Preoperatively Applied Genicular Block on Total Knee Arthroplasty: A Randomized Controlled Study
This prospective, randomized, double-blind, placebo-controlled trial evaluated the analgesic efficacy of preoperative ultrasound-guided genicular nerve block (GNB) in patients undergoing total knee arthroplasty.
A total of 64 patients were randomly assigned to two groups (32 patients per group). The GNB group received 5 mL of 0.25% bupivacaine at each of three genicular nerve targets, whereas the placebo group received 5 mL of 0.9% normal saline at the same anatomical targets.
Read more
All patients underwent standardized general anesthesia and received postoperative multimodal analgesia, including intravenous patient-controlled morphine analgesia.
The primary outcome was movement-evoked pain intensity, assessed using the visual analog scale (VAS) at 24 hours postoperatively. Secondary outcomes included pain scores at other postoperative time points, opioid consumption, and knee range of motion.
Participants and outcome assessors were blinded to group allocation.
Read the detailed description
Patients scheduled for elective primary unilateral total knee arthroplasty were randomly allocated in a 1:1 ratio to the genicular nerve block (GNB) group or the placebo control group.
Approximately 30 minutes before surgery, all patients underwent an ultrasound-guided injection procedure targeting the superomedial, superolateral, and inferomedial genicular nerves.
Patients in the GNB group received 5 mL of 0.25% bupivacaine at each target (total volume: 15 mL). Patients in the placebo control group received 5 mL of 0.9% normal saline at each corresponding target (total volume: 15 mL).
The injections were performed by an anesthesiologist who was aware of group allocation and was not involved in postoperative outcome assessment. Participants and outcome assessors remained blinded to treatment allocation.
All patients received standardized general anesthesia and postoperative multimodal analgesia, including intravenous paracetamol, intramuscular diclofenac, and patient-controlled intravenous morphine analgesia.
Postoperative pain intensity was assessed using the visual analog scale (VAS) at rest and during movement. The primary outcome was movement-evoked VAS at 24 hours after surgery. Secondary outcomes included other postoperative VAS measurements, morphine consumption, and knee range of motion.
- Conditions
- Total Knee Anthroplasty, Genicular Nerves Block
- Being tested
- Genicular blocks (bupivakain), placebo injection with 0.9% sodium chloride, Paracetamol (acetaminophen)+diclofenac, Patient Control Analgesia (PCA) Morphine
- Keywords
- total knee arthroplasty, genicular block, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genicular blocks (bupivakain)Drug
Patients received preoperative ultrasound-guided genicular nerve block with 5 mL of 0.25% bupivacaine injected at each of three anatomical targets: superomedial, superolateral, and inferomedial genicular nerves (total volume: 15 mL).
placebo injection with 0.9% sodium chlorideDrug
Patients received preoperative ultrasound-guided placebo injections consisting of 5 mL of 0.9% normal saline at each of the same three genicular nerve targets (total volume: 15 mL).
Paracetamol (acetaminophen)+diclofenacDrug
Standardized postoperative multimodal analgesia consisting of intravenous paracetamol 1 g every 8 hours and intramuscular diclofenac sodium 75 mg every 12 hours during the first 48 postoperative hours, administered to both study groups.
Patient Control Analgesia (PCA) MorphineDrug
Postoperative intravenous patient-controlled analgesia with morphine, programmed to deliver a 1 mg demand dose with a 15-minute lockout interval. The same PCA regimen was used in both study groups.
| Study group | Role | What they receive |
|---|---|---|
| Genicular block group | Experimental | Patients received preoperative ultrasound-guided genicular nerve block with 5 mL of 0.25% bupivacaine injected at each of three anatomical targets: superomedial, superolateral, and inferomedial genicular nerves (total volume: 15 mL). All patients received standardized general anesthesia and postoperative multimodal analgesia, including intravenous patient-controlled morphine analgesia, paracetamol, and diclofenac. Receives: Drug: Genicular blocks (bupivakain); Drug: Paracetamol (acetaminophen)+diclofenac; Drug: Patient Control Analgesia (PCA) Morphine |
| placebo | Placebo comparator | Patients received preoperative ultrasound-guided placebo injections consisting of 5 mL of 0.9% normal saline at each of the same three genicular nerve targets (total volume: 15 mL). All patients received standardized general anesthesia and postoperative multimodal analgesia, including intravenous patient-controlled morphine analgesia, paracetamol, and diclofenac. Receives: Drug: placebo injection with 0.9% sodium chloride; Drug: Paracetamol (acetaminophen)+diclofenac; Drug: Patient Control Analgesia (PCA) Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale Measure
VAS scores are assessed at 0th, 24th and 48th hours post operatively VAS score consists of 0-10 in numbers, the bigger the number the worse the pain
Measured: 0-48 hours
Secondary outcomes (2)
opioid consumption
Morphine consumption is assesed by PCA
Measured: 0-48 hours
Range of Motion Measurements
Knee range of motion (ROM) are assessed in degrees during active knee flexion. Measurements are obtained preoperatively and at predefined postoperative time points. Higher values indicate greater knee flexion.
Measured: 0-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start15 May 2025
- Primary completion30 Mar 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee AnthroplastyStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Azizoğlu, Mersin University
- Investigators
- Mustafa Azizoglu, Associated Professor, Principal investigator, Mersin university Faculty of Medicine, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942702
- Sponsor's protocol ID
- MersinUgenicular
- Status last verified
- Oct 2026
- First submitted
- 17 Apr 2025
- Last updated
- 19 Oct 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Postoperative Analgesic Efficacy of Preoperatively Applied Genicular Block on Total Knee Arthroplasty: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06942702
- Acronym / sponsor ID
- MersinUgenicular
- Conditions
- Total Knee Anthroplasty, Genicular Nerves Block
- Keywords
- total knee arthroplasty, genicular block, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 24 Apr 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.
This prospective, randomized, double-blind, placebo-controlled trial evaluated the analgesic efficacy of preoperative ultrasound-guided genicular nerve block (GNB) in patients undergoing total knee arthroplasty.
A total of 64 patients were randomly assigned to two groups (32 patients per group). The GNB group received 5 mL of 0.25% bupivacaine at each of three genicular nerve targets, whereas the placebo group received 5 mL of 0.9% normal saline at the same anatomical targets.
All patients underwent standardized general anesthesia and received postoperative multimodal analgesia, including intravenous patient-controlled morphine analgesia.
The primary outcome was movement-evoked pain intensity, assessed using the visual analog scale (VAS) at 24 hours postoperatively. Secondary outcomes included pain scores at other postoperative time points, opioid consumption, and knee range of motion.
Participants and outcome assessors were blinded to group allocation.
Detailed description
Patients scheduled for elective primary unilateral total knee arthroplasty were randomly allocated in a 1:1 ratio to the genicular nerve block (GNB) group or the placebo control group.
Approximately 30 minutes before surgery, all patients underwent an ultrasound-guided injection procedure targeting the superomedial, superolateral, and inferomedial genicular nerves.
Patients in the GNB group received 5 mL of 0.25% bupivacaine at each target (total volume: 15 mL). Patients in the placebo control group received 5 mL of 0.9% normal saline at each corresponding target (total volume: 15 mL).
The injections were performed by an anesthesiologist who was aware of group allocation and was not involved in postoperative outcome assessment. Participants and outcome assessors remained blinded to treatment allocation.
All patients received standardized general anesthesia and postoperative multimodal analgesia, including intravenous paracetamol, intramuscular diclofenac, and patient-controlled intravenous morphine analgesia.
Postoperative pain intensity was assessed using the visual analog scale (VAS) at rest and during movement. The primary outcome was movement-evoked VAS at 24 hours after surgery. Secondary outcomes included other postoperative VAS measurements, morphine consumption, and knee range of motion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genicular block group | Experimental | Drug: Genicular blocks (bupivakain), Drug: Paracetamol (acetaminophen)+diclofenac, Drug: Patient Control Analgesia (PCA) MorphinePatients received preoperative ultrasound-guided genicular nerve block with 5 mL of 0.25% bupivacaine injected at each of three anatomical targets: superomedial, superolateral, and inferomedial genicular nerves (total volume: 15 mL). All patients received standardized general anesthesia and postoperative multimodal analgesia, including intravenous patient-controlled morphine analgesia, paracetamol, and diclofenac. |
| placebo | Placebo comparator | Drug: placebo injection with 0.9% sodium chloride, Drug: Paracetamol (acetaminophen)+diclofenac, Drug: Patient Control Analgesia (PCA) MorphinePatients received preoperative ultrasound-guided placebo injections consisting of 5 mL of 0.9% normal saline at each of the same three genicular nerve targets (total volume: 15 mL). All patients received standardized general anesthesia and postoperative multimodal analgesia, including intravenous patient-controlled morphine analgesia, paracetamol, and diclofenac. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for unilateral and primary total knee arthroplasty
- Older than 18 years of age
Key exclusion criteria (3 listed)
- Younger than 18 years
- Bilateral knee arthroplasty
- Revision case of knee arthroplasty
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 |
|---|---|---|
| Genicular blocks (bupivakain)Patients received preoperative ultrasound-guided genicular nerve block with 5 mL of 0.25% bupivacaine injected at each of three anatomical targets: superomedial, superolateral, and inferomedial genicular nerves (total volume: 15 mL). | Drug | Genicular block group |
| placebo injection with 0.9% sodium chloridePatients received preoperative ultrasound-guided placebo injections consisting of 5 mL of 0.9% normal saline at each of the same three genicular nerve targets (total volume: 15 mL). | Drug | placebo |
| Paracetamol (acetaminophen)+diclofenacStandardized postoperative multimodal analgesia consisting of intravenous paracetamol 1 g every 8 hours and intramuscular diclofenac sodium 75 mg every 12 hours during the first 48 postoperative hours, administered to both study groups. | Drug | Genicular block group, placebo |
| Patient Control Analgesia (PCA) MorphinePostoperative intravenous patient-controlled analgesia with morphine, programmed to deliver a 1 mg demand dose with a 15-minute lockout interval. The same PCA regimen was used in both study groups. | Drug | Genicular block group, placebo |
Primary outcome
Visual Analog Scale Measure
Time frame: 0-48 hours
VAS scores are assessed at 0th, 24th and 48th hours post operatively VAS score consists of 0-10 in numbers, the bigger the number the worse the pain
2 secondary outcomes
opioid consumption
Time frame: 0-48 hours
Range of Motion Measurements
Time frame: 0-48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Total Knee Anthroplasty
Not yet recruiting
Ultrasound Guided Combined Adductor Canal, Superior Genicular Nerves and Anterior Femoral Cutaneous Nerves Blocks in Comparison With Periarticular Local Anesthesia Infiltration in Primary Total Knee Arthroplasty
Total Knee Anthroplasty
Not yet recruitingPhase 4
Smart Knee Evaluation of Exparel and Zynrelef in TKA Recovery
Total Knee Anthroplasty
Active, not recruitingObservational study
Impact of Chronic Venous Insufficiency on Outcomes After Total Knee Arthroplasty
Total Knee Anthroplasty, Venous Insufficiency (Chronic)(Peripheral)
Enrolling by invitation
Using a Smart Implantable Device to Compare Early Recovery in Two Different Knee Arthroplasty Approaches
Total Knee Anthroplasty
Recruiting
Evaluation of Choose to Move Replacement Ready (CTM-RR)
Osteoarthritis (OA), Osteoarthritis (OA) of the Hip
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. This study is not recruiting at the moment.
Mustafa Azizoglu, Associated Professor principal investigator
Mersin university Faculty of Medicine, Department of 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 Genicular blocks (bupivakain) and Paracetamol (acetaminophen)+diclofenac in people with Total Knee Anthroplasty and Genicular Nerves Block, run by Mersin 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 19 Oct 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale Measure (time frame: 0-48 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 19 Oct 2026.