Preemptive IV Ibuprofen for Neurocognitive Recovery and Analgesic Needs After Inguinal Hernia Surgery (IBU-COG)

March 1, 2026 updated by: Mehmet Çiğdem

Effects of Preemptive Ibuprofen Administration on Delayed Neurocognitive Recovery in Geriatric Patients Undergoing Inguinal Hernia Surgery

The primary objective of this study is to evaluate the effects of preemptive intravenous ibuprofen administration on delayed neurocognitive recovery (dNCR), postoperative pain management, and the overall quality of recovery in geriatric patients undergoing open inguinal hernia repair. Elderly patients are particularly susceptible to perioperative neurocognitive dysfunction, which is often triggered by the systemic inflammatory response following surgery and anesthesia.

In this prospective, randomized, double-blind, controlled trial, 76 male patients aged 65-84 were divided into two groups. Group 1 received 800 mg of intravenous ibuprofen 30 minutes before anesthesia induction, while Group 2 received a 0.9% NaCl solution as a placebo. The study focuses on three main clinical outcomes:

  • Neurocognitive Recovery: Cognitive performance is assessed using the Montreal Cognitive Assessment (MoCA) test at baseline, and on postoperative days 1 and 7 to determine if preemptive ibuprofen can reduce the incidence of dNCR by suppressing neuroinflammation.
  • Analgesic Requirement and Pain Control: The study measures postoperative pain scores (VAS) and total opioid (tramadol) consumption over the first 24 hours to evaluate the "opioid-sparing" effect of preemptive ibuprofen.
  • Quality of Recovery: The overall recovery quality is assessed on the 1st postoperative day using the Quality of Recovery-15 (QoR-15) scale, which measures the patient's subjective physical and emotional well-being.

The hypothesis is that by mitigating the surgical inflammatory response, preemptive ibuprofen will protect cognitive function, significantly lower the patient's reliance on opioids, and enhance the overall quality of the postoperative recovery process.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective, randomized, double-blind, placebo-controlled study was designed to investigate the effects of preemptive intravenous ibuprofen on neurocognitive recovery, pain management, and the quality of recovery in geriatric patients. The study included 76 male patients, aged 65-84 years, with an ASA physical status of I-III, scheduled for elective open inguinal hernia repair.

Study Protocol:

Patients were randomly assigned into two equal groups (n=38 each) using a sealed envelope method:

  1. Ibuprofen Group (Group 1): Received 800 mg of intravenous ibuprofen (diluted in 200 mL of 0.9% NaCl) administered via infusion 30 minutes before anesthesia induction.
  2. Control Group (Group 2): Received 200 mL of 0.9% NaCl (placebo) administered via infusion 30 minutes before anesthesia induction.

Anesthesia and Monitoring:

A standardized general anesthesia protocol was applied to all participants. Monitoring included ECG, non-invasive blood pressure, and pulse oximetry. Additionally, the Bispectral Index (BIS) was used to monitor anesthesia depth (target: 40-60), and Near-Infrared Spectroscopy (NIRS) was utilized to monitor bilateral cerebral oxygenation.

Outcomes and Assessments:

  • Neurocognitive Recovery: The Montreal Cognitive Assessment (MoCA) was used to evaluate cognitive functions at three time points: 24 hours preoperatively (baseline), on postoperative day 1 (POD1), and on postoperative day 7 (POD7). Delayed Neurocognitive Recovery (dNCR) was defined as a decrease of \ge2 points in the MoCA score compared to baseline.
  • Analgesic Requirement: Postoperative pain intensity was measured using the Visual Analog Scale (VAS) at rest and during movement at the 1st, 6th, 12th, and 24th hours. Total opioid (tramadol) consumption and the need for rescue analgesia were recorded over the first 24 hours.
  • Quality of Recovery: Subjective recovery quality was assessed on the first postoperative day using the Quality of Recovery-15 (QoR-15) scale, which evaluates physical and emotional well-being.

The study hypothesizes that preemptive ibuprofen administration mitigates the systemic inflammatory response triggered by surgery, thereby reducing neuroinflammation, decreasing postoperative opioid reliance, and improving the overall quality of recovery for elderly patients.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 4

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

  • Turkey (Türkiye)
    • Kadıköy
      • Istanbul, Kadıköy, Turkey (Türkiye), 34710
        • Istanbul medeniyet Universitesi Prof. Dr. Süleyman Yalçın Şehir Hastanesi

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:

  • Male patients between the ages of 65 and 84.
  • ASA (American Society of Anesthesiologists) physical status I - III.
  • Preoperative Mini-Mental State Examination (MMSE) score of \ge24.
  • Undergoing elective (non-emergency) open inguinal hernia repair using the
  • Lichtenstein tension-free method with mesh.
  • Literate and able to communicate sufficiently to understand Turkish cognitive tests.

Exclusion Criteria:

  • Illiterate patients.
  • History of active alcoholism or substance abuse.
  • Neuro-psychiatric disorders such as Parkinson's, Alzheimer's, vascular dementia, advanced stroke sequelae, schizophrenia, or major depressive disorder.
  • Active metastatic cancer or terminal illness.
  • Known allergy to nonsteroidal anti-inflammatory drugs (especially ibuprofen), acetylsalicylic acid, or other drugs used in the study.
  • Advanced COPD or uncontrolled bronchial asthma (FEV1 <50%).
  • Uncontrolled hypertension, congestive heart failure (NYHA Class IV), recent myocardial infarction, or serious arrhythmias.
  • Thrombocytopenia (<50,000), coagulopathy, active peptic ulcer, or recent gastrointestinal bleeding history (within the last year).
  • Advanced liver failure (Child-Pugh C) or kidney failure (creatinine >2.5 mg/dL or dialysis requirement).
  • Body Mass Index (BMI) \ge35 (morbid obesity) or body weight <40 kg.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ibuprofen Group
Geriatric patients undergoing elective open inguinal hernia repair who receive a preemptive infusion of 800 mg intravenous ibuprofen before anesthesia induction.
Drug: Ibuprofen (400 mg x 4)
800 mg intravenous infusion, administered 30 minutes before anesthesia induction.
Other Names:
  • Dorifen®
Placebo Comparator: Control Group
Geriatric patients undergoing elective open inguinal hernia repair who receive a preemptive infusion of 200 mL 0.9% NaCl (saline) before anesthesia induction.
Other: Placebo (NaCl 0.9 % solution)
200 mL of 0.9% normal saline infusion, administered 30 minutes before anesthesia induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montreal Cognitive Assessment (MoCA) Score.
Time Frame: Preoperative Day 1 (Baseline), Postoperative Day 1, and Postoperative Day 7.
The MoCA is a 30-point tool used to evaluate cognitive domains such as memory, attention, and executive functions. A decline of ≥ 2 points from the preoperative baseline is defined as the occurrence of Delayed Neurocognitive Recovery (dNCR).
Preoperative Day 1 (Baseline), Postoperative Day 1, and Postoperative Day 7.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS) Score.
Time Frame: Postoperative 1st, 6th, 12th, and 24th hours.
Pain intensity measured on a scale from 0 (no pain) to 10 (unbearable pain).
Postoperative 1st, 6th, 12th, and 24th hours.
Total Postoperative Tramadol Consumption.
Time Frame: Postoperative 24 hours.
The cumulative amount of intravenous tramadol (in milligrams) administered for pain management over the first 24 hours after surgery.
Postoperative 24 hours.
Quality of Recovery-15 (QoR-15) Score.
Time Frame: Postoperative Day 1.
A 15-item questionnaire assessing the patient's physical and emotional well-being during recovery, with scores ranging from 0 to 150 (higher scores indicate better recovery).
Postoperative Day 1.
Regional Cerebral Oxygen Saturation (rScO2).
Time Frame: From pre-induction (baseline) until the end of surgery (measured at 5, 10, 15, 30, 60, and 90-minute intervals).
Measured via Near-Infrared Spectroscopy (NIRS) to monitor bilateral frontal lobe oxygenation during surgery.
From pre-induction (baseline) until the end of surgery (measured at 5, 10, 15, 30, 60, and 90-minute intervals).

Collaborators and Investigators

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

Sponsor

Mehmet Çiğdem

Collaborators

Goztepe Prof Dr Suleyman Yalcın City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

September 27, 2025

Primary Completion (Actual)

January 22, 2026

Study Completion (Actual)

January 30, 2026

Study Registration Dates

First Submitted

February 15, 2026

First Submitted That Met QC Criteria

February 15, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

March 1, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMU-2025-0072
  • E-24931227-514.04.02-5738966 (Other Identifier: Republic of Türkiye Ministry of Health - Turkish Medicines and Medical Devices Agency (TITCK))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data (IPD) collected during the study will not be shared with external researchers to protect participant confidentiality and comply with the institutional ethics committee guidelines. Only aggregated data and statistical results presented in the final thesis and related publications will be made available.

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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