RecruitingEarly Phase 1NCT05150795

Effect of Preoperative Oral Pregabalin Versus Intraoperative Fentanyl on Postoperative Analgesia

The Effect of Preoperative Oral Pregabalin and Intraoperative Fentanyl on Postoperative Analgesia in Diagnostic Laparoscopic Gynecologic Surgery: a Comparative Study


Sponsor

Ain Shams University

Enrollment

80 participants

Start Date

Jan 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 21 YearsMax Age: 45 Years

Inclusion Criteria1

  • ASA physical status I

Exclusion Criteria6

  • 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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Interventions

DRUGPregabalin 150mg

Compare the postoperative analgesic effect of pre-operative oral pregabalin (Study group), to the intraoperative intravenous fentanyl (Control group) in diagnostic laparoscopic gynecologic surgery.

DRUGFentanyl 100 micrograms ampoule

Compare the postoperative analgesic effect of pre-operative oral pregabalin (Study group), to the intraoperative intravenous fentanyl (Control group) in diagnostic laparoscopic gynecologic surgery.


Locations(1)

Ain-Shams University

Cairo, Egypt

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NCT05150795


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