OsteoarthritisNCT07236073
The Effect of Two Different Analgesic Methods on QoR-40 Score in Primary Unilateral Knee Arthroplasties
A study testing PRİMER TEK TARAFLI DİZ ARTOPLASTİSİNDE İKİ FARKLI ANALJEZİK YÖNTEMİ and knee replacement in people with Osteoarthritis and Knee Arthritis Osteoarthritis, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Total knee arthroplasty (TKA) is a very common operation that increases in frequency with advancing age. Similar to other surgical procedures, strategies are being developed to minimize morbidity and mortality while allowing for rapid recovery and early hospital discharge. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee Arthritis Osteoarthritis, Knee Arthroplasty, Total
- What is being tested?
- PRİMER TEK TARAFLI DİZ ARTOPLASTİSİNDE İKİ FARKLI ANALJEZİK YÖNTEMİ and knee replacement
- 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
- 15 Jul 2023to 30 Dec 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years old
- ASA 1-2
- Those who gave written informed consent for their participation in the study
- Patients undergoing unilateral primary total knee arthroplasty for end-stage osteoarthritis or rheumatoid arthritis
Who cannot join
- Patients undergoing revision total knee arthroplasty
- Opioid addiction
- Preoperative hb, creatinine and electrolytes not within normal limits
- Anticoagulants
- Those allergic to the drugs to be used in the study
- Those with cognitive dysfunction
Show all 12Show fewer
- Patients with more than 40 degrees of knee misalignment (varus or valgus)
- Patients with advanced kidney disease (defined as GFR<30) or severe liver disease
- Patients with poorly controlled diabetes mellitus (HbA1C>7.0 on pre-admission test)
- BMI≥40 patients with
- Any associated intraoperative complications
- Pregnant or lactating female patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Two Different Analgesic Methods on QoR-40 Score in Primary Unilateral Knee Arthroplasties: A Prospective, Randomized Study
Total knee arthroplasty (TKA) is a very common operation that increases in frequency with advancing age. Similar to other surgical procedures, strategies are being developed to minimize morbidity and mortality while allowing for rapid recovery and early hospital discharge.
TKA causes moderate to severe postoperative pain for most patients. The goal of pain control after TKA is to provide excellent analgesia, early mobilization and rehabilitation, and to minimize opioid use, including overprescription of opioids after discharge Multimodal, opioid-sparing strategies for postoperative pain control include regional analgesia techniques (e.g., peripheral nerve blocks, LA infiltration, continuous epidural analgesia, neuraxial opioids) in addition to multimodal systemic analgesics.
Read more
Periarticular injection (PAI), also called local infiltration analgesia, and adductor canal block (ACB), a peripheral nerve block, are increasingly used as a component of multimodal postoperative analgesia and have been shown to reduce pain scores and opioid consumption after TKA. However, the impact of these modalities on the quality of postoperative recovery is unknown. The most widely used method of measuring this is the quality of recovery 40 (QoR 40) questionnaire. This questionnaire places increasing emphasis on measuring overall patient recovery and how quickly a patient can return to daily life after anesthesia and surgery.
Numerous studies have used the postoperative QoR-40 to compare different methods of anesthesia, adjuvants, regional analgesic techniques, and other factors on patient recovery and have been validated in Turkish.
Read the detailed description
Total knee arthroplasty (TKA) is a very common operation that increases in frequency with advancing age. Similar to other surgical procedures, strategies are being developed to minimize morbidity and mortality while allowing for rapid recovery and early hospital discharge.
TKA causes moderate to severe postoperative pain for most patients. The goal of pain control after TKA is to provide excellent analgesia, early mobilization and rehabilitation, and to minimize opioid use, including overprescription of opioids after discharge Multimodal, opioid-sparing strategies for postoperative pain control include regional analgesia techniques (e.g., peripheral nerve blocks, LA infiltration, continuous epidural analgesia, neuraxial opioids) in addition to multimodal systemic analgesics.
Periarticular injection (PAI), also called local infiltration analgesia, and adductor canal block (ACB), a peripheral nerve block, are increasingly used as a component of multimodal postoperative analgesia and have been shown to reduce pain scores and opioid consumption after TKA. However, the impact of these modalities on the quality of postoperative recovery is unknown. The most widely used method of measuring this is the quality of recovery 40 (QoR 40) questionnaire. This questionnaire places increasing emphasis on measuring overall patient recovery and how quickly a patient can return to daily life after anesthesia and surgery.
Numerous studies have used the postoperative QoR-40 to compare different methods of anesthesia, adjuvants, regional analgesic techniques, and other factors on patient recovery and have been validated in Turkish.
This study will be carried out prospectively and randomized on 60 people after obtaining the approval of the ethics committee of Atatürk University Faculty of Medicine Hospital and the written consent of the patients.
Patients will be randomized by a statistician using a computerized random numbers table and divided into 2 equal groups as Group PAI+ACB and Group ACB. All patients will undergo spinal anesthesia with 12 mg isobaric bupivacaine + 15 mcg fentanyl. Afterwards, patients in Group PAI+ACU will undergo PAI by the surgeon with a total of 120 ml of local anesthetic-containing fluid before cementing during the operation, and patients in this group will undergo ACU with 15 ml of 0.25% bupivacaine and 1:200000 thousand adrenaline at the end of the operation. Patients in group ACB will have an adductor canal block catheter placed at the end of the operation and 0.1% bupivacaine will be given postoperatively through this catheter as a bolus every three hours.
Patients will be given 1000 mg acetaminophen every six hours starting from the preoperative period, 8 mg iv dexamethasone, 4 mg iv ondansetron, 100 mcg/kg/min propofol infusion intraoperatively, 100 mcg iv fentanyl or 10 to 40 iv ketamine for analgesia when necessary, and 400 mg iboprufen every eight hours in addition to acetaminophen, 5 or 10 mg oxycodone for pain, and 25 mcg fentanyl for severe pain (VAS≥7) postoperatively. Patients will also receive 1 gram of tranexamic acid before skin incision and at the end of surgery.
QoR40 scores of the patients will be evaluated and recorded on the preoperative day and postoperative days 1 and 2 using the Turkish version of the QoR40 score.
- Being tested
- PRİMER TEK TARAFLI DİZ ARTOPLASTİSİNDE İKİ FARKLI ANALJEZİK YÖNTEMİ, knee replacement
- Keywords
- Osteoarthritis, Knee, Postoperative Pain
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRİMER TEK TARAFLI DİZ ARTOPLASTİSİNDE İKİ FARKLI ANALJEZİK YÖNTEMİProcedure or surgery
PRİMER TEK TARAFLI DİZ ARTOPLASTİSİNDE İKİ FARKLI ANALJEZİK YÖNTEMİN QoR-40 PUANI ÜZERİNE ETKİSİ: PROSPEKTİF, RANDOMİZE BİR ÇALIŞMA
knee replacementProcedure or surgery
postoperative recovery quality score
| Study group | Role | What they receive |
|---|---|---|
| THE EFFECT OF TWO DIFFERENT ANALGESIC METHODS | Active comparator | Patients will be randomized into two equal groups by a statistician using a computerized random numbers table:
Group 1 (PAI+ACB): Patients will undergo periarticular injection (PAI) by the surgeon with 120 ml of local anesthetic-containing fluid before cementing, and receive an adductor canal block (ACB) with 15 ml of 0.25% bupivacaine and 1:200,000 adrenaline at the end of the operation.
Group 2 (ACB): Patients will receive an adductor canal block catheter placed at the end of the operation and will receive 0.1% bupivacaine through this catheter as a bolus every three hours postoperatively. Receives: Procedure: PRİMER TEK TARAFLI DİZ ARTOPLASTİSİNDE İKİ FARKLI ANALJEZİK YÖNTEMİ; Procedure: knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Levels Measured by the Visual Analog Scale (VAS)
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), which ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
Measured: 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours, 36 hours, and 48 hours after surgery.
Secondary outcomes (1)
Quality of Recovery as Measured by the Quality of Recovery-40 (QoR-40) Questionnaire
The Quality of Recovery-40 (QoR-40) questionnaire will be used to evaluate patients' postoperative recovery quality. The scale ranges from 40 to 200 points, with higher scores indicating better recovery. The Turkish validated version of the QoR-40 will be used.
Measured: Preoperatively (baseline), postoperative day 1, and postoperative day 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start15 Jul 2023
- Primary completion10 Mar 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Dostbil, Ataturk University
- Investigators
- Dostbil, Principal investigator, Ataturk Univercity Ethics Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236073
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/534
- Status last verified
- Nov 2025
- First submitted
- 29 Sep 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Analgesic Methods on QoR-40 Score in Primary Unilateral Knee Arthroplasties: A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT07236073
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/534
- Keywords
- Osteoarthritis, Knee, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 19 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.
Total knee arthroplasty (TKA) is a very common operation that increases in frequency with advancing age. Similar to other surgical procedures, strategies are being developed to minimize morbidity and mortality while allowing for rapid recovery and early hospital discharge.
TKA causes moderate to severe postoperative pain for most patients. The goal of pain control after TKA is to provide excellent analgesia, early mobilization and rehabilitation, and to minimize opioid use, including overprescription of opioids after discharge Multimodal, opioid-sparing strategies for postoperative pain control include regional analgesia techniques (e.g., peripheral nerve blocks, LA infiltration, continuous epidural analgesia, neuraxial opioids) in addition to multimodal systemic analgesics.
Periarticular injection (PAI), also called local infiltration analgesia, and adductor canal block (ACB), a peripheral nerve block, are increasingly used as a component of multimodal postoperative analgesia and have been shown to reduce pain scores and opioid consumption after TKA. However, the impact of these modalities on the quality of postoperative recovery is unknown. The most widely used method of measuring this is the quality of recovery 40 (QoR 40) questionnaire. This questionnaire places increasing emphasis on measuring overall patient recovery and how quickly a patient can return to daily life after anesthesia and surgery.
Numerous studies have used the postoperative QoR-40 to compare different methods of anesthesia, adjuvants, regional analgesic techniques, and other factors on patient recovery and have been validated in Turkish.
Detailed description
Total knee arthroplasty (TKA) is a very common operation that increases in frequency with advancing age. Similar to other surgical procedures, strategies are being developed to minimize morbidity and mortality while allowing for rapid recovery and early hospital discharge.
TKA causes moderate to severe postoperative pain for most patients. The goal of pain control after TKA is to provide excellent analgesia, early mobilization and rehabilitation, and to minimize opioid use, including overprescription of opioids after discharge Multimodal, opioid-sparing strategies for postoperative pain control include regional analgesia techniques (e.g., peripheral nerve blocks, LA infiltration, continuous epidural analgesia, neuraxial opioids) in addition to multimodal systemic analgesics.
Periarticular injection (PAI), also called local infiltration analgesia, and adductor canal block (ACB), a peripheral nerve block, are increasingly used as a component of multimodal postoperative analgesia and have been shown to reduce pain scores and opioid consumption after TKA. However, the impact of these modalities on the quality of postoperative recovery is unknown. The most widely used method of measuring this is the quality of recovery 40 (QoR 40) questionnaire. This questionnaire places increasing emphasis on measuring overall patient recovery and how quickly a patient can return to daily life after anesthesia and surgery.
Numerous studies have used the postoperative QoR-40 to compare different methods of anesthesia, adjuvants, regional analgesic techniques, and other factors on patient recovery and have been validated in Turkish.
This study will be carried out prospectively and randomized on 60 people after obtaining the approval of the ethics committee of Atatürk University Faculty of Medicine Hospital and the written consent of the patients.
Patients will be randomized by a statistician using a computerized random numbers table and divided into 2 equal groups as Group PAI+ACB and Group ACB. All patients will undergo spinal anesthesia with 12 mg isobaric bupivacaine + 15 mcg fentanyl. Afterwards, patients in Group PAI+ACU will undergo PAI by the surgeon with a total of 120 ml of local anesthetic-containing fluid before cementing during the operation, and patients in this group will undergo ACU with 15 ml of 0.25% bupivacaine and 1:200000 thousand adrenaline at the end of the operation. Patients in group ACB will have an adductor canal block catheter placed at the end of the operation and 0.1% bupivacaine will be given postoperatively through this catheter as a bolus every three hours.
Patients will be given 1000 mg acetaminophen every six hours starting from the preoperative period, 8 mg iv dexamethasone, 4 mg iv ondansetron, 100 mcg/kg/min propofol infusion intraoperatively, 100 mcg iv fentanyl or 10 to 40 iv ketamine for analgesia when necessary, and 400 mg iboprufen every eight hours in addition to acetaminophen, 5 or 10 mg oxycodone for pain, and 25 mcg fentanyl for severe pain (VAS≥7) postoperatively. Patients will also receive 1 gram of tranexamic acid before skin incision and at the end of surgery.
QoR40 scores of the patients will be evaluated and recorded on the preoperative day and postoperative days 1 and 2 using the Turkish version of the QoR40 score.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| THE EFFECT OF TWO DIFFERENT ANALGESIC METHODS | Active comparator | Procedure: PRİMER TEK TARAFLI DİZ ARTOPLASTİSİNDE İKİ FARKLI ANALJEZİK YÖNTEMİ, Procedure: knee replacementPatients will be randomized into two equal groups by a statistician using a computerized random numbers table: Group 1 (PAI+ACB): Patients will undergo periarticular injection (PAI) by the surgeon with 120 ml of local anesthetic-containing fluid before cementing, and receive an adductor canal block (ACB) with 15 ml of 0.25% bupivacaine and 1:200,000 adrenaline at the end of the operation. Group 2 (ACB): Patients will receive an adductor canal block catheter placed at the end of the operation and will receive 0.1% bupivacaine through this catheter as a bolus every three hours postoperatively. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years old
- ASA 1-2
- Those who gave written informed consent for their participation in the study
- Patients undergoing unilateral primary total knee arthroplasty for end-stage osteoarthritis or rheumatoid arthritis
Key exclusion criteria (12 listed)
- Patients undergoing revision total knee arthroplasty
- Opioid addiction
- Preoperative hb, creatinine and electrolytes not within normal limits
- Anticoagulants
- Those allergic to the drugs to be used in the study
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 |
|---|---|---|
| PRİMER TEK TARAFLI DİZ ARTOPLASTİSİNDE İKİ FARKLI ANALJEZİK YÖNTEMİPRİMER TEK TARAFLI DİZ ARTOPLASTİSİNDE İKİ FARKLI ANALJEZİK YÖNTEMİN QoR-40 PUANI ÜZERİNE ETKİSİ: PROSPEKTİF, RANDOMİZE BİR ÇALIŞMA | Procedure or surgery | THE EFFECT OF TWO DIFFERENT ANALGESIC METHODS |
| knee replacementpostoperative recovery quality score | Procedure or surgery | THE EFFECT OF TWO DIFFERENT ANALGESIC METHODS |
Primary outcome
Postoperative Pain Levels Measured by the Visual Analog Scale (VAS)
Time frame: 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours, 36 hours, and 48 hours after surgery.
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS), which ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
1 secondary outcome
Quality of Recovery as Measured by the Quality of Recovery-40 (QoR-40) Questionnaire
Time frame: Preoperatively (baseline), postoperative day 1, and postoperative day 2.
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 21 Jan 2026.
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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.
Dostbil principal investigator
Ataturk Univercity Ethics Committee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRİMER TEK TARAFLI DİZ ARTOPLASTİSİNDE İKİ FARKLI ANALJEZİK YÖNTEMİ and knee replacement in people with Osteoarthritis and Knee Arthritis Osteoarthritis, run by Ataturk 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 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 21 Jan 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?
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 Pain Levels Measured by the Visual Analog Scale (VAS) (time frame: 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours, 36 hours, and 48 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 21 Jan 2026.