Postoperative Pain Control in Elderly Knee Replacement
Official title: Effects of Different Analgesic Approaches on Postoperative Delirium in Elderly Patients Undergoing Total Knee Arthroplasty
Run by Ankara City Hospital Bilkent · NCT07849517 · Data updated 2026-11-12
This study tests two pain-management methods after knee replacement in adults 60 and older to see which one reduces delirium and improves recovery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 60 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Ankara City Hospital Bilkent Academic / other |
| Locations | 1 site (Ankara, Çankaya) |
| Status | Recruiting |
| Started | October 1, 2026 |
| Main results expected | May 25, 2027 |
| Study ends | June 15, 2027 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07849517 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 60 years and older undergoing elective unilateral total knee arthroplasty under spinal anesthesia with ASA I–III.
✕Probably not a fit
Patients with contraindications to spinal anesthesia, those requiring general anesthesia, or with preexisting cognitive impairment or psychiatric/neurological disorders affecting cognition may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective randomized trial compares periarticular infiltration with adductor canal block plus BiFes block for postoperative analgesia in elderly patients undergoing elective unilateral total knee arthroplasty under spinal anesthesia. Primary outcome is delirium incidence measured by 3D-CAM at 12, 24, 48 hours and on day 7 after surgery. Secondary outcomes include pain scores, need for rescue opioids, time to first mobilization, length of hospital stay, recovery score, and patient satisfaction. The goal is to identify an analgesic approach that provides effective pain control while minimizing neurocognitive complications and supporting faster recovery in this population.
Why it matters
Potential benefit: If successful, the approach could reduce delirium and improve postoperative recovery and satisfaction for elderly knee arthroplasty patients.
How similar studies have gone: Previous studies in regional analgesia for knee arthroplasty have shown benefits for pain and recovery, though results specifically linking delirium reduction to the tested blocks are variable.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing elective unilateral total knee arthroplasty under spinal anesthesia * ASA physical status I-III * Age ≥60 years * Body mass index (BMI) between 18-30 kg/m² * Preoperative fasting duration of approximately 8 hours Exclusion Criteria: * Refusal to participate in the study or inability to provide written informed consent * American Society of Anesthesiologists (ASA) physical status IV or higher * Obese patients (BMI \>30 kg/m²) or cachectic patients (BMI \<18 kg/m²) * Patients requiring general anesthesia or in whom spinal anesthesia could not be achieved * Contraindications to spinal anesthesia * Emergency surgeries * Psychiatric or neurological disorders causing cognitive dysfunction (e.g., epilepsy, schizophrenia, dementia, Alzheimer's disease) * Use of psychotropic or opioid medications, or a history of alcohol abuse or withdrawal within the last 6 months * Mini-Mental State Examination (MMSE) score ≤24 * Stage III-IV hepatic encephalopathy * Severe impairments preventing cognitive assessment, such as blindness or severe hearing loss * Patients meeting delirium criteria according to baseline 3D-CAM assessment or unable to complete the test * History of cranio-cerebral surgery * Acute myocardial infarction within the previous 12 months before surgery * Requirement for postoperative intensive care unit admission
Where it's running
-
Ankara Bilkent City Hospital
Ankara, Çankaya, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Fatma Kavak Akelma
- Email: fatmakavakakelma@yahoo.com
- Phone: 03125962553
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.