- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06736405
Effect of Pericapsular Nerve Group Block on Postoperative Cognitive Function
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)?
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ankara
-
Çankaya, Ankara, Turkey, 06530
- Ankara Bilkent City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Patients who require blood or blood product transfusion during surgery
- Patients who cannot cooperate in the postoperative period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Pericapsular nerve group block
Pericapsular nerve group block will be applied to patients in addition to standard treatment to prevent postoperative pain.
|
Pericapsular nerve group block will be applied to patients in addition to standard treatment to prevent postoperative pain
|
|
Active Comparator: No Pericapsular nerve group block
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
11 - point numerical rating scale (NRS)
Time Frame: 3 months
|
11-point numerical rating scale for pain (0='no pain' and 10='worst pain possible pain') were explained
|
3 months
|
|
Mobilization
Time Frame: 3 days
|
The time from the patient's first assisted mobilization start will be recorded in hours
|
3 days
|
|
Rescue analgesic requirement
Time Frame: 3 days
|
Number of additional analgesic applications
|
3 days
|
|
Discharge time
Time Frame: 7 days
|
Postoperative hospital discharge time
|
7 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- POCD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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