The Effect of Two Different Analgesic Methods on QoR-40 Score in Primary Unilateral Knee Arthroplasties

NCT07236073 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/534
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Osteoarthritis; Knee Arthritis Osteoarthritis; Knee Arthroplasty, Total

Keywords

Osteoarthritis, Knee; Postoperative Pain

Outcome Measures

Primary Outcomes (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.

  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

  Preoperatively (baseline), postoperative day 1, and postoperative day 2.

Study Arms (1)

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.

Procedure: PRİMER TEK TARAFLI DİZ ARTOPLASTİSİNDE İKİ FARKLI ANALJEZİK YÖNTEMİ; Procedure: knee replacement

Interventions

knee replacement PROCEDURE

postoperative recovery quality score

THE EFFECT OF TWO DIFFERENT ANALGESIC METHODS

PRİMER TEK TARAFLI DİZ ARTOPLASTİSİNDE İKİ FARKLI ANALJEZİK YÖNTEMİ PROCEDURE

PRİMER TEK TARAFLI DİZ ARTOPLASTİSİNDE İKİ FARKLI ANALJEZİK YÖNTEMİN QoR-40 PUANI ÜZERİNE ETKİSİ: PROSPEKTİF, RANDOMİZE BİR ÇALIŞMA

THE EFFECT OF TWO DIFFERENT ANALGESIC METHODS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, Erzurum, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee; Pain, Postoperative

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Dostbil

  Ataturk Univercity Ethics Committee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: November 19, 2025
• Study Start: July 15, 2023
• Primary Completion: March 10, 2025
• Study Completion: December 30, 2025
• Last Updated: January 21, 2026

Record last verified: 2025-11

Locations

TU (1)