Clinical trial NCT05150795: Effect of Preoperative Oral Pregabalin Versus Intraoperative Fentanyl on Postoperative Analgesia
Official title: The Effect of Preoperative Oral Pregabalin and Intraoperative Fentanyl on Postoperative Analgesia in Diagnostic Laparoscopic Gynecologic Surgery: a Comparative Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Post Operative Pain, Acute
Keywords: pregabalin
analgesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 80
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in post-operative pain score at rest over time
timeFrame: 1 hour
measure: Changes in post-operative pain score on coughing over time
timeFrame: 1 hour
Secondary outcomes:
measure: Pre-operative level of patient sedation assessed by the sedation score
timeFrame: 1 hour
measure: Duration of surgery
timeFrame: 2 hours
measure: Duration of anesthesia
timeFrame: 3 hours
measure: mean values of systolic blood pressure (SBP)
timeFrame: 4 hours
measure: Intra-operative additional doses of fentanyl given
timeFrame: 3 hours
measure: Postoperative level of patient sedation
timeFrame: 1 hour
measure: Post-operative pain score
timeFrame: 12 hours
measure: Pethidine requirements
timeFrame: 1 hour
measure: sPO2
timeFrame: 4 hours
measure: changes in mean values of diastolic blood pressure (DBP)
timeFrame: 4 hours
measure: changes in mean values of mean blood pressure (MBP)
timeFrame: 4 hours
measure: mean values of heart rate (HR)
timeFrame: 4 hours
measure: total dose of pethidine given to the patient
timeFrame: 12 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University
Study officials:
References: