Actively Recruiting

Early Phase 1
Age: 21Years - 45Years
FEMALE
Healthy Volunteers
NCT05150795

Effect of Preoperative Oral Pregabalin Versus Intraoperative Fentanyl on Postoperative Analgesia

Led by Ain Shams University · Updated on 2025-01-29

80

Participants Needed

1

Research Sites

256 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effect of Preoperative Oral Pregabalin Versus Intraoperative Fentanyl on Postoperative Analgesia

Who Can Participate

Age: 21Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged between 21 and 45 years
  • ASA physical status I (healthy without systemic disease)
Not Eligible

You will not qualify if you...

  • Patients who refuse to participate
  • Use of sedatives, hypnotics, antipsychotic, or antidepressant drugs
  • History of drug or alcohol abuse
  • History of chronic pain
  • Daily intake of analgesics
  • History of epilepsy disease or diagnosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ain-Shams University

Cairo, Egypt

Actively Recruiting

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Research Team

G

Ghada Mohamed Samir, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Effect of Preoperative Oral Pregabalin Versus Intraoperative Fentanyl on Postoperative Analgesia | DecenTrialz