- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07236073
The Effect of Two Different Analgesic Methods on QoR-40 Score in Primary Unilateral Knee Arthroplasties
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.
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.
Study Overview
Status
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Erzurum
-
Erzurum, Erzurum, Turkey (Türkiye), 25000
- Ataturk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: THE EFFECT OF TWO DIFFERENT ANALGESIC METHODS
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. |
PRİMER TEK TARAFLI DİZ ARTOPLASTİSİNDE İKİ FARKLI ANALJEZİK YÖNTEMİN QoR-40 PUANI ÜZERİNE ETKİSİ: PROSPEKTİF, RANDOMİZE BİR ÇALIŞMA
postoperative recovery quality score
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours, 36 hours, and 48 hours after surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
Preoperatively (baseline), postoperative day 1, and postoperative day 2.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dostbil, Ataturk Univercity Ethics Committee
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Postoperative Complications
- Pathologic Processes
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain, Postoperative
- Osteoarthritis
- Osteoarthritis, Knee
- Surgical Procedures, Operative
- Arthroplasty, Replacement
- Arthroplasty
- Orthopedic Procedures
- Plastic Surgery Procedures
- Prosthesis Implantation
- Arthroplasty, Replacement, Knee
Other Study ID Numbers
- B.30.2.ATA.0.01.00/534
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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