NCT06736405

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)?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

December 19, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2025

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2025

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

November 13, 2024

Last Update Submit

August 14, 2025

Conditions

Keywords

Total hip replacementPericapsular nerve group blocPostoperative cognitive dysfunction

Outcome Measures

Primary Outcomes (1)

  • Frequency of postoperative cognitive dysfunction (POCD)

    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 Outcomes (4)

  • 11 - point numerical rating scale (NRS)

    3 months

  • Mobilization

    3 days

  • Rescue analgesic requirement

    3 days

  • Discharge time

    7 days

Study Arms (2)

Pericapsular nerve group block

ACTIVE COMPARATOR

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

Other: Pericapsular nerve group block

No Pericapsular nerve group block

ACTIVE COMPARATOR

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

Other: No Pericapsular nerve group block

Interventions

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

Pericapsular nerve group block

Patients will be given standard treatment to prevent postoperative pain

No Pericapsular nerve group block

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Çankaya, Ankara, 06530, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation specialist doctor

Study Record Dates

First Submitted

November 13, 2024

First Posted

December 16, 2024

Study Start

December 19, 2024

Primary Completion

July 18, 2025

Study Completion

August 14, 2025

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations