Postoperative DeliriumNCT07849517
Postoperative Delirium and Analgesia in Elderly Patients
A study testing adductor canal block and biFes block including bupivacain and Periarticular infiltration in people with Postoperative Delirium and Postoperative Pain, Acute, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of different postoperative analgesic approaches on postoperative delirium in elderly patients undergoing total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Delirium, Postoperative Pain, Acute
- What is being tested?
- adductor canal block and biFes block including bupivacain and Periarticular infiltration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, Çankaya, 06800
FATMA KAVAKAKELMA, MD, 5327079113 ext. +90, fatmakavak@yahoo.com
Aleyna Calap Ocak, MD, 5452847074 ext. +90, aleynacalap@gmail.com
About this study
Official title: Effects of Different Analgesic Approaches on Postoperative Delirium in Elderly Patients Undergoing Total Knee Arthroplasty
This study aims to evaluate the effects of different postoperative analgesic approaches on postoperative delirium in elderly patients undergoing total knee arthroplasty.
Read the 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.
- Conditions
- Postoperative Delirium, Postoperative Pain, Acute
- Being tested
- adductor canal block and biFes block including bupivacain, Periarticular infiltration
- Keywords
- Spinal anesthesia, Time to discharge, Rescue Opioid Requirement, Patient Satisfaction, Periarticular infiltration, Adductor canal block, BiFes block
- Medical subject headings
- Emergence Delirium, Pain, Postoperative, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adductor canal block and biFes block including bupivacainDrug
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 infiltrationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Adductor canal block and BiFes block | Active comparator | 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. Receives: Drug: adductor canal block and biFes block including bupivacain |
| Periarticular infiltration | Active comparator | 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. Receives: Drug: Periarticular infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days postoperative
Secondary outcomes (6)
NRS ( Numeric Rating Scale )
11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained.
Measured: 48 hours postoperative
Rescue Opioid Requirement
The need for rescue opioid use and the administered dose will be recorded for each patient.
Measured: 48 hours postoperative
Time to discharge
Time to discharge will be defined as the duration from the end of surgery to hospital discharge, measured in hours.
Measured: up to 7 days
Patient Satisfaction Score
Patient satisfaction will assess prior to discharge using a Likert scale type (range, 1 to 10) verbally administered questionnaire.
Measured: 48 hours postoperative
White's fast-track score
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 )
Measured: up to 7 days
Time to first mobilization
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.
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Oct 2026
- Primary completion25 May 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Kavak Akelma, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849517
- Sponsor's protocol ID
- delirium
- Other IDs
- E2-26 15370
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Analgesic Approaches on Postoperative Delirium in Elderly Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07849517
- Acronym / sponsor ID
- delirium
- Conditions
- Postoperative Delirium, Postoperative Pain, Acute
- Keywords
- Spinal anesthesia, Time to discharge, Rescue Opioid Requirement, Patient Satisfaction, Periarticular infiltration, Adductor canal block, BiFes block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 25 May 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor canal block and BiFes block | Active comparator | Drug: adductor canal block and biFes block including bupivacainParticipants 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 | Active comparator | Drug: Periarticular infiltrationParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adductor canal block and biFes block including bupivacainParticipants 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. | Drug | Adductor canal block and BiFes block |
| Periarticular infiltrationParticipants 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. | Drug | Periarticular infiltration |
Primary outcome
Postoperative Delirium
Time frame: 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.
6 secondary outcomes
NRS ( Numeric Rating Scale )
Time frame: 48 hours postoperative
Rescue Opioid Requirement
Time frame: 48 hours postoperative
Time to discharge
Time frame: up to 7 days
Patient Satisfaction Score
Time frame: 48 hours postoperative
White's fast-track score
Time frame: up to 7 days
Time to first mobilization
Time frame: up to 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Postoperative Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adductor canal block and biFes block including bupivacain and Periarticular infiltration in people with Postoperative Delirium and Postoperative Pain, Acute, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact FATMA KAVAK AKELMA (03125962553, fatmakavakakelma@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Delirium (time frame: 7 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.