Postoperative PainNCT07077720
COMPARISON OF THE EFFECT OF DISTAL ADDUCTOR CANAL BLOCK COMBINED WITH GENICULAR NERVE BLOCK OR PERIARTICULAR INJECTION ON POSTOPERATIVE QOR-15 IN TOTAL KNEE ARTHROPLASTIES
A study testing genicular nerve block, periarticular injection and Addukctor canal block in people with Postoperative Pain and Recovery, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study compares the effects of genicular nerve block (GNB) and periarticular injection (PAI), added to distal adductor canal block (ACB), on postoperative recovery quality (QoR-15), morphine use, and pain scores after total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Recovery
- What is being tested?
- genicular nerve block, periarticular injection and Addukctor canal block
- 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
- 30 Jan 2025to 3 Jul 2025
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for knee arthroplasty
- Patients classified as ASA I, II, or III
- Patients aged 18 years and older
Who cannot join
- Patients with a known allergy to any of the drugs used in the study
- Presence of infection near the puncture site
- History or presence of neurological disorders (e.g., transient ischemic attack, syncope, dementia, etc.)
- Known coagulation disorders
- History of alcohol or substance abuse
- Impaired consciousness
Show all 12Show fewer
- Chronic opioid use equal to or exceeding 60 mg of oral morphine equivalents per day
- Pre-existing neuropathic pain
- Hepatic failure, renal failure, or cardiac insufficiency
- Uncontrolled diabetes mellitus
- Pregnant or breastfeeding women
- Refusal or inability to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COMPARISON OF THE EFFECT OF DISTAL ADDUCTOR CANAL BLOCK COMBINED WITH GENICULAR NERVE BLOCK OR PERIARTICULAR INJECTION ON POSTOPERATIVE QOR-15 IN TOTAL KNEE ARTHROPLASTIES: A RANDOMIZED CONTROLLED STUDY
Objective: This study compares the effects of genicular nerve block (GNB) and periarticular injection (PAI), added to distal adductor canal block (ACB), on postoperative recovery quality (QoR-15), morphine use, and pain scores after total knee arthroplasty (TKA).
Methods: Sixty patients received spinal anesthesia and distal ACB, then were randomized to GNB (Group G, n=30) or PAI (Group P, n=30). QoR-15, morphine consumption, VAS pain scores, nausea/vomiting, and side effects were evaluated.
Read the detailed description
Objective: Total knee arthroplasty (TKA) is a common surgical procedure for knee pathologies of various etiologies, where postoperative pain management is critical for early mobilization and rehabilitation. Different blockade techniques targeting the femoral, obturator, and sciatic nerves, which provide sensory innervation to the knee, are evaluated in terms of analgesic efficacy and preservation of motor function. The adductor canal block (ACB) targets the saphenous nerve without affecting motor function, whereas periarticular injection (PAI) and genicular nerve block (GNB) provide more comprehensive analgesia by blocking other branches of the femoral nerve as well as the obturator and sciatic nerves. This study aims to compare the effects of GNB and PAI, applied in addition to distal ACB, on postoperative recovery quality measured by the Quality of Recovery-15 (QoR-15) score, morphine consumption, and pain scores in patients undergoing TKA.
Materials and Methods: This single-center, randomized, prospective study included patients over 18 years of age with ASA physical status I-III who were scheduled for total knee arthroplasty under spinal anesthesia. All patients received spinal anesthesia with 15 mg isobaric bupivacaine combined with 100 mcg intrathecal morphine. Additionally, all patients underwent ultrasound-guided distal adductor canal block. Patients were randomized into Group G (n=30) and Group P (n=30). Group G received preoperative genicular nerve block (5+5+5 ml of 0.25% bupivacaine), whereas Group P received intraoperative periarticular injection administered by the surgical team, consisting of 8 mg morphine, 40 mg methylprednisolone, 0.3 mg adrenaline, 750 mg cefazolin and 110 mg bupivacaine. The primary outcome measure was the quality of recovery evaluated by the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours postoperatively. Secondary outcomes included morphine consumption at 2., 6., 12. and 24 hours postoperatively, resting and movement Visual Analog Scale (VAS) pain scores, postoperative nausea and vomiting (PONV) scores, and the incidence of adverse effects such as respiratory depression, urinary retention, and pruritus.
- Conditions
- Postoperative Pain, Recovery
- Being tested
- genicular nerve block, periarticular injection, Addukctor canal block, Spinal Anesthesia with Bupivacaine and Morphine
- Keywords
- Total Knee Arthroplasty, Genicular nerve bloc, periarticular injection, QoR-15
- 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 nerve blockProcedure or surgery
genicular nerve block with a total of 15 mL of 0.25% bupivacaine preoperatively
periarticular injectionProcedure or surgery
periarticular injection prepared by the surgical team containing 8 mg morphine, 40 mg methylprednisolone, 0.3 mg adrenaline, 750 mg cefazolin, and 110 mg bupivacaine.
Addukctor canal blockProcedure or surgery
Addukctor canal block with 15ml %0.25 bupivacaine
Spinal Anesthesia with Bupivacaine and MorphineProcedure or surgery
Spinal Anesthesia with Bupivacaine(isobaris 15-18mg) and Morphine(100mcg)
| Study group | Role | What they receive |
|---|---|---|
| Grup G | Active comparator | Genicular nerve block Receives: Procedure: genicular nerve block; Procedure: Addukctor canal block; Procedure: Spinal Anesthesia with Bupivacaine and Morphine |
| Grup P | Active comparator | Periarticular injecrion Receives: Procedure: periarticular injection; Procedure: Addukctor canal block; Procedure: Spinal Anesthesia with Bupivacaine and Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative 24th hour qor-15
Postoperative 24th hour qor-15 score
Measured: Postoperative 24th hour
Secondary outcomes (4)
Postoperative 2nd, 6th, 12th, and 24th hour morphine consumption
Postoperative 2nd, 6th, 12th, and 24th hour morphine consumption
Measured: Postoperative 2nd, 6th, 12th, and 24th hour
Postoperative 2nd, 6th, 12th, and 24th hour resting VAS score
Postoperative 2nd, 6th, 12th, and 24th hour resting VAS score
Measured: Postoperative 2nd, 6th, 12th, and 24th hour
Postoperative 2nd, 6th, 12th, and 24th hour movement VAS score
Postoperative 2nd, 6th, 12th, and 24th hour movement VAS score
Measured: Postoperative 2nd, 6th, 12th, and 24th hour
Postoperative 2nd, 6th, 12th, and 24th hour adverse effects
Postoperative 2nd, 6th, 12th, and 24th hour adverse effects
Measured: Postoperative 2nd, 6th, 12th, and 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start30 Jan 2025
- Primary completion15 Jun 2025
- Study completion3 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Çağrı Sarıarslan, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077720
- Sponsor's protocol ID
- 29.01.2025-E.180706
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 22 Jul 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 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF THE EFFECT OF DISTAL ADDUCTOR CANAL BLOCK COMBINED WITH GENICULAR NERVE BLOCK OR PERIARTICULAR INJECTION ON POSTOPERATIVE QOR-15 IN TOTAL KNEE ARTHROPLASTIES: A RANDOMIZED CONTROLLED STUDY
- ClinicalTrials.gov ID
- NCT07077720
- Acronym / sponsor ID
- 29.01.2025-E.180706
- Conditions
- Postoperative Pain, Recovery
- Keywords
- Total Knee Arthroplasty, Genicular nerve bloc, periarticular injection, QoR-15
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 22 Jul 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.
Objective: This study compares the effects of genicular nerve block (GNB) and periarticular injection (PAI), added to distal adductor canal block (ACB), on postoperative recovery quality (QoR-15), morphine use, and pain scores after total knee arthroplasty (TKA).
Methods: Sixty patients received spinal anesthesia and distal ACB, then were randomized to GNB (Group G, n=30) or PAI (Group P, n=30). QoR-15, morphine consumption, VAS pain scores, nausea/vomiting, and side effects were evaluated.
Detailed description
Objective: Total knee arthroplasty (TKA) is a common surgical procedure for knee pathologies of various etiologies, where postoperative pain management is critical for early mobilization and rehabilitation. Different blockade techniques targeting the femoral, obturator, and sciatic nerves, which provide sensory innervation to the knee, are evaluated in terms of analgesic efficacy and preservation of motor function. The adductor canal block (ACB) targets the saphenous nerve without affecting motor function, whereas periarticular injection (PAI) and genicular nerve block (GNB) provide more comprehensive analgesia by blocking other branches of the femoral nerve as well as the obturator and sciatic nerves. This study aims to compare the effects of GNB and PAI, applied in addition to distal ACB, on postoperative recovery quality measured by the Quality of Recovery-15 (QoR-15) score, morphine consumption, and pain scores in patients undergoing TKA.
Materials and Methods: This single-center, randomized, prospective study included patients over 18 years of age with ASA physical status I-III who were scheduled for total knee arthroplasty under spinal anesthesia. All patients received spinal anesthesia with 15 mg isobaric bupivacaine combined with 100 mcg intrathecal morphine. Additionally, all patients underwent ultrasound-guided distal adductor canal block. Patients were randomized into Group G (n=30) and Group P (n=30). Group G received preoperative genicular nerve block (5+5+5 ml of 0.25% bupivacaine), whereas Group P received intraoperative periarticular injection administered by the surgical team, consisting of 8 mg morphine, 40 mg methylprednisolone, 0.3 mg adrenaline, 750 mg cefazolin and 110 mg bupivacaine. The primary outcome measure was the quality of recovery evaluated by the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours postoperatively. Secondary outcomes included morphine consumption at 2., 6., 12. and 24 hours postoperatively, resting and movement Visual Analog Scale (VAS) pain scores, postoperative nausea and vomiting (PONV) scores, and the incidence of adverse effects such as respiratory depression, urinary retention, and pruritus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grup G | Active comparator | Procedure: genicular nerve block, Procedure: Addukctor canal block, Procedure: Spinal Anesthesia with Bupivacaine and MorphineGenicular nerve block |
| Grup P | Active comparator | Procedure: periarticular injection, Procedure: Addukctor canal block, Procedure: Spinal Anesthesia with Bupivacaine and MorphinePeriarticular injecrion |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for knee arthroplasty
- Patients classified as ASA I, II, or III
- Patients aged 18 years and older
Key exclusion criteria (12 listed)
- Patients with a known allergy to any of the drugs used in the study
- Presence of infection near the puncture site
- History or presence of neurological disorders (e.g., transient ischemic attack, syncope, dementia, etc.)
- Known coagulation disorders
- History of alcohol or substance abuse
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 nerve blockgenicular nerve block with a total of 15 mL of 0.25% bupivacaine preoperatively | Procedure or surgery | Grup G |
| periarticular injectionperiarticular injection prepared by the surgical team containing 8 mg morphine, 40 mg methylprednisolone, 0.3 mg adrenaline, 750 mg cefazolin, and 110 mg bupivacaine. | Procedure or surgery | Grup P |
| Addukctor canal blockAddukctor canal block with 15ml %0.25 bupivacaine | Procedure or surgery | Grup G, Grup P |
| Spinal Anesthesia with Bupivacaine and MorphineSpinal Anesthesia with Bupivacaine(isobaris 15-18mg) and Morphine(100mcg) | Procedure or surgery | Grup G, Grup P |
Primary outcome
Postoperative 24th hour qor-15
Time frame: Postoperative 24th hour
Postoperative 24th hour qor-15 score
4 secondary outcomes
Postoperative 2nd, 6th, 12th, and 24th hour morphine consumption
Time frame: Postoperative 2nd, 6th, 12th, and 24th hour
Postoperative 2nd, 6th, 12th, and 24th hour resting VAS score
Time frame: Postoperative 2nd, 6th, 12th, and 24th hour
Postoperative 2nd, 6th, 12th, and 24th hour movement VAS score
Time frame: Postoperative 2nd, 6th, 12th, and 24th hour
Postoperative 2nd, 6th, 12th, and 24th hour adverse effects
Time frame: Postoperative 2nd, 6th, 12th, and 24th hour
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 22 Jul 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 nerve block, periarticular injection and Addukctor canal block in people with Postoperative Pain and Recovery, run by Bezmialem Vakif 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 3 inclusion and 12 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 22 Jul 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?
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?
Postoperative 24th hour qor-15 (time frame: Postoperative 24th hour). 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 22 Jul 2025.