Effect of Pericapsular Nerve Group Block on Postoperative Cognitive Function

NCT ID: NCT06736405

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-19
• Study Completion Date: 2025-08-14

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).

Conditions

Total Hip Replacement; Pericapsular Nerve Group Bloc; Postoperative Cognitive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Pericapsular nerve group block

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

Group Type: ACTIVE_COMPARATOR

Pericapsular nerve group block

Intervention Type: OTHER

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

No Pericapsular nerve group block

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

Group Type: ACTIVE_COMPARATOR

No Pericapsular nerve group block

Intervention Type: OTHER

Patients will be given standard treatment to prevent postoperative pain

Interventions

Pericapsular nerve group block

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

Intervention Type: OTHER

No Pericapsular nerve group block

Patients will be given standard treatment to prevent postoperative pain

Intervention Type: OTHER

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.)
• 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Gökhan Erdem

Anesthesiology and Reanimation specialist doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Bilkent City Hospital

Çankaya, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

POCD

Identifier Type: -

Identifier Source: org_study_id