Effect of Preoperative Oral Pregabalin Versus Intraoperative Fentanyl on Postoperative Analgesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pregabalin 150mg, Fentanyl 100 micrograms ampoule.
- Who it may be relevant to
- Registry conditions: Post Operative Pain, Acute. Basic parameters: 21 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Preoperative Oral Pregabalin and Intraoperative Fentanyl on Postoperative Analgesia in Diagnostic Laparoscopic Gynecologic Surgery: a Comparative Study
Overview
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.
Interventions
- Drug 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. - 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.
Primary outcome measures
- Changes in post-operative pain score at rest over time [Time frame: 1 hour]
- Changes in post-operative pain score on coughing over time [Time frame: 1 hour]
Secondary outcome measures (12)
- Pre-operative level of patient sedation assessed by the sedation score [Time frame: 1 hour]
- Duration of surgery [Time frame: 2 hours]
- Duration of anesthesia [Time frame: 3 hours]
- mean values of systolic blood pressure (SBP) [Time frame: 4 hours]
- Intra-operative additional doses of fentanyl given [Time frame: 3 hours]
- Postoperative level of patient sedation [Time frame: 1 hour]
- Post-operative pain score [Time frame: 12 hours]
- Pethidine requirements [Time frame: 1 hour]
- sPO2 [Time frame: 4 hours]
- changes in mean values of diastolic blood pressure (DBP) [Time frame: 4 hours]
- changes in mean values of mean blood pressure (MBP) [Time frame: 4 hours]
- mean values of heart rate (HR) [Time frame: 4 hours]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Ain-Shams University — Cairo
Identifiers
NCT: NCT05150795 · R18/2020/2021