Postoperative Delirium, Postoperative Pain, Acute
Conditions
Keywords
Spinal anesthesia, Time to discharge, Rescue Opioid Requirement, Patient Satisfaction, Periarticular infiltration, Adductor canal block, BiFes block
Brief summary
This study aims to evaluate the effects of different postoperative analgesic approaches on postoperative delirium in elderly patients undergoing total knee arthroplasty.
Detailed description
This prospective randomized controlled study will evaluate the effects of two different postoperative analgesic approaches on postoperative delirium in elderly patients undergoing elective unilateral total knee arthroplasty under spinal anesthesia. Patients aged 60 years and older will be allocated into two groups according to the analgesic technique applied: Periarticular infiltration or adductor canal block combined with biceps femoris short head (BiFes) block. The primary outcome of the study is the incidence of postoperative delirium assessed using the 3D-CAM test at postoperative 12th, 24th, and 48th hours and on postoperative day 7. Secondary outcomes include postoperative pain scores (VAS/NRS), rescue opioid requirement, time to first mobilization, length of hospital stay, White's Fast-Track Score and patient satisfaction assessed with a Likert scale. The study aims to identify the optimal analgesic approach that provides effective pain control while minimizing neurocognitive complications and improving postoperative recovery in elderly patients undergoing total knee arthroplasty.
Interventions
DRUGadductor canal block and biFes block including bupivacain
Participants in this arm received postoperative analgesia via ultrasound-guided adductor canal block combined with BiFes block using 20 mL of 0.25% bupivacaine for each block following total knee arthroplasty under spinal anesthesia.
Participants in this arm received postoperative analgesia with periarticular infiltration consisting of 100 mg bupivacaine, 40 mg methylprednisolone, 0.5 mg adrenaline and salin solution during total knee arthroplasty under spinal anesthesia.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Delirium | 7 days postoperative | Postoperative delirium incidence assessed using the Diagnostic Interview for the Confusion Assessment Method (3D-CAM) in patients with a Mini-Mental State Examination score greater than 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NRS ( Numeric Rating Scale ) | 48 hours postoperative | 11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained. |
| Rescue Opioid Requirement | 48 hours postoperative | The need for rescue opioid use and the administered dose will be recorded for each patient. |
| Time to discharge | up to 7 days | Time to discharge will be defined as the duration from the end of surgery to hospital discharge, measured in hours. |
| Patient Satisfaction Score | 48 hours postoperative | Patient satisfaction will assess prior to discharge using a Likert scale type (range, 1 to 10) verbally administered questionnaire. |
| White's fast-track score | up to 7 days | Postoperative recovery will be assessed using the White's Fast-Track Score, which evaluates recovery based on activity level, hemodynamic stability, pain, nausea/vomiting, respiratory status, and consciousness level. ( range, 1 to 14 ) |
| Time to first mobilization | up to 7 days | Time to first mobilization will be defined as the time elapsed between the end of surgery and the patient's first successful mobilization, measured in hours. |
Countries
Turkey (Türkiye)
Contacts
CONTACTFATMA KAVAK AKELMA
CONTACTALEYNA CALAP OCAK
Outcome results
None listed