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COMPLETED
NCT07138053
NA

The Impact Opioid Free Anesthesia on Postoperative Pain Intensity and Stress Response After Open Gynecology Surgery

Sponsor: Cantonal Hospital Zenica

View on ClinicalTrials.gov

Summary

This study compared impact of multimodal balancing anesthesia vs opioid free anesthesia on postoperative pain intensity and stress response after open gynecology surgery. Hypothesis was: opioid free anesthesia reduces postoperative pain intensity and stress response in terms of the value for pain in VAS (Visual Analog Scala) and for stress response in value of cortisol, prolactin and IL-6, CRP and improves postoperative patients subjective well-being and surgical outcome.

Official title: The Impact of Multimodal Balancing Anesthesia vs Opioid Free Anesthesia on Postoperative Pain Intensity and Stress Response After Open Gynecology Surgery

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2025-08-22

Completion Date

2026-03-30

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

OTHER

OFA group

OFA group Participants received intravenous midazolam (3 mg) and paracetamol (1 g) approximately 30 min before surgery. After standard monitoring was established, magnesium sulfate (40 mg/kg) was administered intravenously over 10 min, followed by dexamethasone (6 mg) before induction. Dexmedetomidine (0.7-1.0 μg/kg) and lidocaine (1.5 mg/kg) loading doses were initiated 10 min before induction. Anaesthesia was induced with propofol (2 mg/kg/TT) and and vecuronium bromide (0.1 mg/kg). Ketamine (0.5-1.0 mg/kg) was administered immediately before tracheal intubation, with further doses when clinically indicated. Anaesthesia was maintained with sevoflu and Dexmedetomidine (0.5-1.0 μg/kg/h) and lidocaine (1.0-1.5 mg/kg/h) infusion discontinued after last surgical sutures. TAP bloc ultrasound guided performed after intubation. Ketamine given 60 sec before incision in doses 0.5 mg/kg, and after if it is necessary according to ER and qNOX. Provided value range between 40-60 during surgery.

Locations (1)

Cantonal Hospital Zenica

Zenica, Zenica, Bosnia and Herzegovina