Effect of Pericapsular Nerve Group Block on Postoperative Cognitive Function

August 14, 2025 updated by: Gökhan Erdem, Ankara City Hospital Bilkent

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

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 Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ankara
      • Çankaya, Ankara, Turkey, 06530
        • Ankara Bilkent City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2024

Primary Completion (Actual)

July 18, 2025

Study Completion (Actual)

August 14, 2025

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

December 13, 2024

First Posted (Actual)

December 16, 2024

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 14, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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