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Recruiting EARLY_Phase 1 NCT05150795

Effect of Preoperative Oral Pregabalin Versus Intraoperative Fentanyl on Postoperative Analgesia

Trial Parameters

Condition Post Operative Pain, Acute
Sponsor Ain Shams University
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 80
Sex FEMALE
Min Age 21 Years
Max Age 45 Years
Start Date 2022-01-01
Completion 2026-12
Interventions
Pregabalin 150mgFentanyl 100 micrograms ampoule

Brief Summary

Pregabalin is a structural analogue of gamma amino butyric acid (GABA). It binds to presynaptic alpha-2-delta subunit of voltage gated calcium channels in the brain and the spinal cord. Thus, it modulates the release of excitatory neurotransmitters, such as glutamate, norepinephrine, substance-P, and calcitonin gene related peptide. Also, it causes inhibitory modulation of overexcited neurons and restores them to a normal state. Pre-emptive analgesia aims to reduce postoperative opioid consumption especially in ambulatory surgeries. Pregabalin (PGB) is an emerging drug in this field. Different doses of preoperative oral pregabalin (75, 150 and 300 mg) are described in the literature with a dose-response analgesic relationship and reduction of opioid use; however increasing the dose results in increasing the incidence of side effects mainly sedation and dizziness. Perioperative use of opioids for analgesia may result in side effects; like nausea, vomiting, excessive sedation, respiratory depression, pruritus, and urinary retention.The concomitant use of opioids with pregabalin may result in excess sedation and somnolence, so, the use of opioids with pregabalin should be limited to patients with inadequate alternative options.

Eligibility Criteria

Inclusion Criteria: * ASA physical status I Exclusion Criteria: * Patients' refusal * use of sedatives, hypnotics, anti-psychotic or antidepressant drugs * history of drug/alcohol abuse * history of chronic pain * daily intake of analgesics * history of epilepsy

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