Effect of Preoperative Oral Pregabalin Versus Intraoperative Fentanyl on Postoperative Analgesia

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age21-45
SponsorAin Shams University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

ASA physical status I

Disqualifiers

Patients' refusal

use of sedatives, hypnotics, anti-psychotic or antidepressant drugs

history of drug/alcohol abuse

history of chronic pain

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pregabalin 150mg

    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.

  • Fentanyl 100 micrograms ampoule

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Group PregabalinActive comparator 1 intervention
Group B: Group FentanylActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in post-operative pain score at rest over time

Intensity of pain will be monitored at 15 and 30min after arrival to the PACU, then 1h before discharge from the PACU. For analysis, pain severity will be categorized as absent (VAS=0), mild (VAS=1-3), moderate (VAS=4-7), severe (VAS=7-9), and very severe (VAS=10).

Time frame
1 hour
2

Changes in post-operative pain score on coughing over time

Intensity of pain will be monitored at 15 and 30min after arrival to the PACU, then 1h before discharge from the PACU. For analysis, pain severity will be categorized as absent (VAS=0), mild (VAS=1-3), moderate (VAS=4-7), severe (VAS=7-9), and very severe (VAS=10).

Time frame
1 hour

Secondary outcomes

1

Pre-operative level of patient sedation assessed by the sedation score

assessed 1 hour after administering the oral capsules by the sedation score from 0 to 4. 0=Awake and agitated, 1= Awake and comfortable, 2= Asleep and arousable, 3= Asleep with sluggish response to verbal commands or touch, 4= No response to verbal command or touch.

Time frame
1 hour
2

Duration of surgery

Measured in minutes

Time frame
2 hours
3

Duration of anesthesia

Measured in minutes

Time frame
3 hours
4

mean values of systolic blood pressure (SBP)

mean values of SBP at pre-operative baseline, before induction of anesthesia, 5min after endotracheal intubation, before pneumoperitoneum, during the first 30 minutes (at 10, 20 and 30 min) of pneumoperitoneum, after release of pneumoperitoneum and 10 min after extubation in the PACU

Time frame
4 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.