Effect of Pericapsular Nerve Group Block on Postoperative Cognitive Function
1 other identifier
interventional
84
1 country
1
Brief 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. 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)?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2024
CompletedFirst Posted
Study publicly available on registry
December 16, 2024
CompletedStudy Start
First participant enrolled
December 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 14, 2025
CompletedAugust 15, 2025
August 1, 2025
7 months
November 13, 2024
August 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months
Secondary Outcomes (4)
11 - point numerical rating scale (NRS)
3 months
Mobilization
3 days
Rescue analgesic requirement
3 days
Discharge time
7 days
Study Arms (2)
Pericapsular nerve group block
ACTIVE COMPARATORPericapsular nerve group block will be applied to patients in addition to standard treatment to prevent postoperative pain.
No Pericapsular nerve group block
ACTIVE COMPARATORPericapsular nerve group block will be applied to patients in addition to standard treatment to prevent postoperative pain.
Interventions
Pericapsular nerve group block will be applied to patients in addition to standard treatment to prevent postoperative pain
Patients will be given standard treatment to prevent postoperative pain
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara Bilkent City Hospital
Çankaya, Ankara, 06530, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiology and Reanimation specialist doctor
Study Record Dates
First Submitted
November 13, 2024
First Posted
December 16, 2024
Study Start
December 19, 2024
Primary Completion
July 18, 2025
Study Completion
August 14, 2025
Last Updated
August 15, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share