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Completed

NCT Number: NCT06736405

Effect of Pericapsular Nerve Group Block on Postoperative Cognitive Function

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)?

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Çankaya, Ankara, 06530, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pericapsular nerve group block

Other

Pericapsular nerve group block will be applied to patients in addition to standard treatment to prevent postoperative pain

No Pericapsular nerve group block

Other

Patients will be given standard treatment to prevent postoperative pain

Primary outcomes

  1. 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

  1. 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

  2. Mobilization

    Time frame: 3 days

    The time from the patient's first assisted mobilization start will be recorded in hours

  3. Rescue analgesic requirement

    Time frame: 3 days

    Number of additional analgesic applications

  4. Discharge time

    Time frame: 7 days

    Postoperative hospital discharge time

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2024
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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