Health TrialsbyHealthPanel

Postoperative Delirium and Analgesia in Elderly Patients

ConditionsPostoperative DeliriumPostoperative Pain, Acute
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorAnkara City Hospital Bilkent

About this trial

This study aims to evaluate the effects of different postoperative analgesic approaches on postoperative delirium in elderly patients undergoing total knee arthroplasty.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • adductor canal block and biFes block including bupivacain

    Drug

    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.

  • Periarticular infiltration

    Drug

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Adductor canal block and BiFes blockActive comparator 1 intervention
Group B: Periarticular infiltrationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Delirium

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.

Time frame
7 days postoperative

Secondary outcomes

1

NRS ( Numeric Rating Scale )

11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.

Time frame
48 hours postoperative
2

Rescue Opioid Requirement

The need for rescue opioid use and the administered dose will be recorded for each patient.

Time frame
48 hours postoperative
3

Time to discharge

Time to discharge will be defined as the duration from the end of surgery to hospital discharge, measured in hours.

Time frame
up to 7 days
4

Patient Satisfaction Score

Patient satisfaction will assess prior to discharge using a Likert scale type (range, 1 to 10) verbally administered questionnaire.

Time frame
48 hours postoperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ankara City Hospital Bilkent

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: