AzTrials
AzTrials

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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
What is being tested?
PRİMER TEK TARAFLI DİZ ARTOPLASTİSİNDE İKİ FARKLI ANALJEZİK YÖNTEMİ and knee replacement
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.

Turkey (Türkiye)1 site
  • Ataturk University

    Erzurum, Erzurum, 25000

Other trials in Turkey (Türkiye)

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 groups in NCT07236073
Study groupRoleWhat they receive
THE EFFECT OF TWO DIFFERENT ANALGESIC METHODSActive comparatorPatients 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.

  1. 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)
  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.

  1. First posted19 Nov 2025
  2. Study start15 Jul 2023
  3. Primary completion10 Mar 2025
  4. Study completion30 Dec 2025

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in