Total Hip ReplacementNCT06736405
Effect of Pericapsular Nerve Group Block on Postoperative Cognitive Function
A study testing Pericapsular nerve group block and No Pericapsular nerve group block in people with Total Hip Replacement and Pericapsular Nerve Group Bloc, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the effect of pericapsular nerve group (PENG) block, which is frequently applied for postoperative analgesia in total hip replacement surgeries performed under spinal anesthesia, on postoperative cognitive function in patients aged 65 years and older. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Total Hip Replacement, Pericapsular Nerve Group Bloc, Postoperative Cognitive Dysfunction
- What is being tested?
- Pericapsular nerve group block and No Pericapsular nerve group block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Dec 2024to 14 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients who will undergo surgery with spinal anesthesia due to total hip replacement
- ASA (American Society of Anesthesiologists) I-II-III patients
- Patients aged 65 and over
- Patients with a preoperative fasting period of approximately 8 hours
Who cannot join
- Refusal to participate in the study
- ASA (American Society of Anesthesiologists) score of 4 and above
- Body mass index >40 kg/m²)
- Failure of spinal block
- Patients who underwent surgery with general anesthesia
- Patients who received preoperative and intraoperative sedation
Show all 17Show fewer
- Patients who will undergo revision surgery
- Patients with a history of drug use
- Patients with psychiatric disorders or those taking antipsychotic medications (depression, bipolar disorder, schizophrenia, etc.)
- Patients with central nervous system disease (Alzheimer's disease, Parkinson's disease, multiple sclerosis, etc.)
- Patients who do not accept spinal anesthesia and/or pericapsular nerve group (PENG) block
- Patients with a preoperative Mini Mental Test (MMT) score below 25
- Patients with contraindications for regional anesthesia techniques
- Patients who developed perioperative delirium
- Patients with visual or hearing impairment
- Patients who require blood or blood product transfusion during surgery
- Patients who cannot cooperate in the postoperative period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Çankaya, Ankara, 06530
About this study
Official title: Effect of Pericapsular Nerve Group Block on Postoperative Cognitive Function in Total Hip Replacement Surgery
The aim of this study was to examine the effect of pericapsular nerve group (PENG) block, which is frequently applied for postoperative analgesia in total hip replacement surgeries performed under spinal anesthesia, on postoperative cognitive function in patients aged 65 years and older.
The main question of the study is as follows:
Can the analgesic effect of preoperative PENG block without causing motor block in total hip replacement surgeries performed under spinal anesthesia in patients aged 65 years and older reduce the incidence of postoperative cognitive dysfunction (POCD)?
Read the detailed description
Patients aged 65 years and older, with (American Society of Anesthesiologists) ASA physical status I, II and III, and scheduled for total hip arthroplasty surgery under spinal anesthesia will be included in the study. Patient characteristics (age, gender, body mass index, etc.), Confusion Assessment Method (CAM), Yesavage Geriatric Depression Scale, Frail Frailty and Mini-Mental State Examination (MMSE) performed face-to-face will be recorded. Preoperatively, 24-72 hours before, patients' cognitive functions will be re-evaluated out of 26 points with telephone versions of the MMSE (T-MMSE). Intraoperatively, surgical duration, dermatomal block level due to spinal anesthesia, ephedrine or atropine requirement, pulse and blood pressure values will be recorded during the surgery. One group will receive a single dose ipsilateral pericapsular nerve group (PENG) block (20 ml 0.25% plain bupivacaine) under ultrasound guidance before surgery. The other group will receive a sham block. Cognitive function of the patients will be evaluated with T-MMSE on the 1st, 7th, 30th and 90th days postoperatively. Postoperative pain status of the patients will be recorded face-to-face at 0, 2, 8, 16, 24 and 48 hours, and via telephone on the 7th, 30th and 90th days with numerical rating scale (NRS).
- Being tested
- Pericapsular nerve group block, No Pericapsular nerve group block
- Keywords
- Total hip replacement, Pericapsular nerve group bloc, Postoperative cognitive dysfunction
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericapsular nerve group blockOther
Pericapsular nerve group block will be applied to patients in addition to standard treatment to prevent postoperative pain
No Pericapsular nerve group blockOther
Patients will be given standard treatment to prevent postoperative pain
| Study group | Role | What they receive |
|---|---|---|
| Pericapsular nerve group block | Active comparator | Pericapsular nerve group block will be applied to patients in addition to standard treatment to prevent postoperative pain. Receives: Other: Pericapsular nerve group block |
| No Pericapsular nerve group block | Active comparator | Pericapsular nerve group block will be applied to patients in addition to standard treatment to prevent postoperative pain. Receives: Other: No Pericapsular nerve group block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of postoperative cognitive dysfunction (POCD)
The primary outcome of the study was the frequency of postoperative cognitive dysfunction (POCD). Postoperative cognitive function of the patients will be evaluated with telephone versions of the Mini-Mental State Examination (T-MMSE) between 0 and 26 points. Higher scores indicate better cognitive function. POCD was defined as a decline of ≥1 standard deviation (SD) from the baseline T-MMSE score, observed at postoperative day 7, day 30, or day 90.
Measured: 3 months
Secondary outcomes (4)
11 - point numerical rating scale (NRS)
11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained
Measured: 3 months
Mobilization
The time from the patient's first assisted mobilization start will be recorded in hours
Measured: 3 days
Rescue analgesic requirement
Number of additional analgesic applications
Measured: 3 days
Discharge time
Postoperative hospital discharge time
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start19 Dec 2024
- Primary completion18 Jul 2025
- Study completion14 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
- 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökhan Erdem, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736405
- Sponsor's protocol ID
- POCD
- Status last verified
- Aug 2025
- First submitted
- 13 Nov 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erdem G, Nalbant B, Kavak Akelma F, Saglam E, Erdem D, Lafci A. Effect of pericapsular nerve group block on postoperative cognitive function in older patients undergoing total hip arthroplasty. Anaesthesiologie. 2026 Apr;75(4):242-251. doi: 10.1007/s00101-026-01654-6. Epub 2026 Feb 20.
PubMed 41721091
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pericapsular Nerve Group Block on Postoperative Cognitive Function in Total Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT06736405
- Acronym / sponsor ID
- POCD
- Keywords
- Total hip replacement, Pericapsular nerve group bloc, Postoperative cognitive dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 16 Dec 2024 (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.
The aim of this study was to examine the effect of pericapsular nerve group (PENG) block, which is frequently applied for postoperative analgesia in total hip replacement surgeries performed under spinal anesthesia, on postoperative cognitive function in patients aged 65 years and older.
The main question of the study is as follows:
Can the analgesic effect of preoperative PENG block without causing motor block in total hip replacement surgeries performed under spinal anesthesia in patients aged 65 years and older reduce the incidence of postoperative cognitive dysfunction (POCD)?
Detailed description
Patients aged 65 years and older, with (American Society of Anesthesiologists) ASA physical status I, II and III, and scheduled for total hip arthroplasty surgery under spinal anesthesia will be included in the study. Patient characteristics (age, gender, body mass index, etc.), Confusion Assessment Method (CAM), Yesavage Geriatric Depression Scale, Frail Frailty and Mini-Mental State Examination (MMSE) performed face-to-face will be recorded. Preoperatively, 24-72 hours before, patients' cognitive functions will be re-evaluated out of 26 points with telephone versions of the MMSE (T-MMSE). Intraoperatively, surgical duration, dermatomal block level due to spinal anesthesia, ephedrine or atropine requirement, pulse and blood pressure values will be recorded during the surgery. One group will receive a single dose ipsilateral pericapsular nerve group (PENG) block (20 ml 0.25% plain bupivacaine) under ultrasound guidance before surgery. The other group will receive a sham block. Cognitive function of the patients will be evaluated with T-MMSE on the 1st, 7th, 30th and 90th days postoperatively. Postoperative pain status of the patients will be recorded face-to-face at 0, 2, 8, 16, 24 and 48 hours, and via telephone on the 7th, 30th and 90th days with numerical rating scale (NRS).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pericapsular nerve group block | Active comparator | Other: Pericapsular nerve group blockPericapsular nerve group block will be applied to patients in addition to standard treatment to prevent postoperative pain. |
| No Pericapsular nerve group block | Active comparator | Other: No Pericapsular nerve group blockPericapsular nerve group block will be applied to patients in addition to standard treatment to prevent postoperative pain. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients who will undergo surgery with spinal anesthesia due to total hip replacement
- ASA (American Society of Anesthesiologists) I-II-III patients
- Patients aged 65 and over
- Patients with a preoperative fasting period of approximately 8 hours
Key exclusion criteria (17 listed)
- Refusal to participate in the study
- ASA (American Society of Anesthesiologists) score of 4 and above
- Body mass index >40 kg/m²)
- Failure of spinal block
- Patients who underwent surgery with general 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 |
|---|---|---|
| Pericapsular nerve group blockPericapsular nerve group block will be applied to patients in addition to standard treatment to prevent postoperative pain | Other | Pericapsular nerve group block |
| No Pericapsular nerve group blockPatients will be given standard treatment to prevent postoperative pain | Other | No Pericapsular nerve group block |
Primary outcome
Frequency of postoperative cognitive dysfunction (POCD)
Time frame: 3 months
The primary outcome of the study was the frequency of postoperative cognitive dysfunction (POCD). Postoperative cognitive function of the patients will be evaluated with telephone versions of the Mini-Mental State Examination (T-MMSE) between 0 and 26 points. Higher scores indicate better cognitive function. POCD was defined as a decline of ≥1 standard deviation (SD) from the baseline T-MMSE score, observed at postoperative day 7, day 30, or day 90.
4 secondary outcomes
11 - point numerical rating scale (NRS)
Time frame: 3 months
Mobilization
Time frame: 3 days
Rescue analgesic requirement
Time frame: 3 days
Discharge time
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Derived from this study: PubMed 41721091Erdem G, Nalbant B, Kavak Akelma F, Saglam E, Erdem D, Lafci A. Effect of pericapsular nerve group block on postoperative cognitive function in older patients undergoing total hip arthroplasty. Anaesthesiologie. 2026 Apr;75(4):242-251. doi: 10.1007/s00101-026-01654-6. Epub 2026 Feb 20.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pericapsular nerve group block and No Pericapsular nerve group block in people with Total Hip Replacement and Pericapsular Nerve Group Bloc, 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 4 inclusion and 17 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: finished, as of the sponsor's last update on 15 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of postoperative cognitive dysfunction (POCD) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06736405, which also lists 1 linked publication.
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 15 Aug 2025.