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Clinical Trials/NCT06736405
NCT06736405
Completed
Not Applicable

Effect of Pericapsular Nerve Group Block on Postoperative Cognitive Function in Total Hip Replacement Surgery

Ankara City Hospital Bilkent1 site in 1 country84 target enrollmentDecember 19, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Hip Replacement
Sponsor
Ankara City Hospital Bilkent
Enrollment
84
Locations
1
Primary Endpoint
Frequency of postoperative cognitive dysfunction (POCD)
Status
Completed
Last Updated
8 months ago

Overview

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)?

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).

Registry
clinicaltrials.gov
Start Date
December 19, 2024
End Date
August 14, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gökhan Erdem

Anesthesiology and Reanimation specialist doctor

Ankara City Hospital Bilkent

Eligibility Criteria

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.)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 11 - point numerical rating scale (NRS)(3 months)
  • Mobilization(3 days)
  • Rescue analgesic requirement(3 days)
  • Discharge time(7 days)

Study Sites (1)

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