MedTrace Logo

Preemptive IV Ibuprofen for Neurocognitive Recovery and Analgesic Needs After Inguinal Hernia Surgery

NCT07424001 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-03-03

No results posted yet for this study

Summary

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.

Conditions

  • Inguinal Hernia Unilateral
  • Delayed Neurocognitive Recovery
  • Postoperative Pain
  • Neuroinflammation
  • Preemptive Analgesia

Interventions

DRUG

Ibuprofen (400 mg x 4)

800 mg intravenous infusion, administered 30 minutes before anesthesia induction.

OTHER

Placebo (NaCl 0.9 % solution)

200 mL of 0.9% normal saline infusion, administered 30 minutes before anesthesia induction.

Sponsors & Collaborators

  • Goztepe Prof Dr Suleyman Yalcın City Hospital

    collaborator OTHER

  • Mehmet Çiğdem

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
84 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-27
Primary Completion
2026-01-22
Completion
2026-01-30

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07424001 on ClinicalTrials.gov