Effect of Preoperative Oral Pregabalin Versus Intraoperative Fentanyl on Postoperative Analgesia

NCT ID: NCT05150795

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2026-12-31

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.

Detailed Description

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

Patienrs will be selected by simple randomization by computer generated system. Pregabalin 150 mg oral capsule and a placebo capsule will be available on the morning of operation.

Also, 2 syringes of 10 ml volumes will be prepared; the first contains normal saline and the second contains the fentanyl dose of 1 µg /kg calculated according to the patient's body weight and diluted to a 10 ml volume.

Patients will then be divided into 2 equal groups of 40 patients each:

Group P: Patients will receive oral pregabalin capsule (150 mg) 90 min before induction of anesthesia, and will receive a bolus injection of 10 ml saline at induction of anesthesia.

Group F: Patients will receive oral placebo capsule identical to the trial drug in size, shape and color, 90 min before induction of anesthesia and will receive a bolus injection of 10 ml of 1µg /kg fentanyl at induction of anesthesia.

Conditions

Post Operative Pain, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group Pregabalin

Patients will receive oral pregabalin capsule (150 mg) 90 min before induction of anesthesia, and will receive a bolus injection of 10 ml saline at induction of anesthesia

Group Type: ACTIVE_COMPARATOR

Pregabalin 150mg

Intervention Type: DRUG

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

Group Fentanyl

Patients will receive oral placebo capsule identical to the trial drug in size, shape and color, 90 min before induction of anesthesia and will receive a bolus injection of 10 ml of 1µg /kg fentanyl at induction of anesthesia

Group Type: ACTIVE_COMPARATOR

Fentanyl 100 micrograms ampoule

Intervention Type: DRUG

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

Interventions

Pregabalin 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.

Intervention Type: DRUG

Fentanyl 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ghada M.Samir

Assistant Professor of Anesthesia, Intensive care and Pain Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain-Shams University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ghada Mohamed Samir, MD

Role: CONTACT

dr.ghada216@gmail.com

01005043691 ext. 002

Facility Contacts

Ghada Mohamed Samir, MD

Role: primary

dr.ghada216@gmail.com

01005043691 ext. 002

Other Identifiers

R18/2020/2021

Identifier Type: -

Identifier Source: org_study_id