Pregabalin due to its antihyperalgesic effect, has proven its efficacy on neuropathic pain, essentially in nociceptive surgeries. Few studies have attempted to identify the utility of pregabalin as a premedication before cesarean delivery. The investigators aimed to determine whether or not pregabalin as premedication improves analgesia post cesarean delivery.
The investigators conducted a controlled, randomised, prospective and double-blind trial. One hundred thirty eight participants were included, with American Society of Anesthesiologists physical status classification of I to II, with pregnancies of at least 36 weeks of gestation who were scheduled for elective caesarean delivery under spinal anaesthesia. One hour before induction of anaesthesia participants received a capsule containing sugar placebo (placebo group), pregabalin 150 mg or pregabalin 300 mg. Data related to surgical history, pre-existing medical problems, indications for cesarean and peroperative hemodynamic changes were analyzed. The primary outcome was first analgesic request. Secondary outcomes included maternal pain scores at rest and during movement, rescue analgesics consumption, sedation, nausea, vomiting, pruritus and Apgar scores. All maternal secondary outcome variables were recorded 0, 2, 4, 6, 12, 18, and 24 h after delivery. Common side effects linked to pregabalin such as somnolence, blurred or abnormal vision, or fetal distress were collected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
138
two capsules, one is placebo, the other correspond to pregabalin 150 mg ingested orally one hour before cesarean section
two capsules filled with sugar ingested orally one hour before cesarean section
two capsules of pregabalin 150 mg ingested orally one hour before cesarean section
Monastir maternity and neonatology center
Monastir, Tunisia
Time to first analgesic request
in minutes, the time between the end of the operation to the first demand of analgesics
Time frame: 24 hours
Visual analog scale (VAS) at rest and movement
Checked at hours 2, 4, 6,12,18 and 24 post operatively
Time frame: 24 hours
Maternal satisfaction
Measured by a Visual Analog Scale, ranging from 0 to 100; 0=not satisfied at all
Time frame: 24 hours
Maternal consumption of paracetamol postoperatively
grams
Time frame: 24 hours
Apgar scores
Ranging from 0 to 10; 7 to 10 correspond to an excellent condition
Time frame: 1 and 5 minutes after birth
Heart rate
beats per minute
Time frame: Per operative period
Non-invasive blood pressure
measured in millimeters of mercury
Time frame: Per operative period
Visual disturbances
present or not
Time frame: 24 hours post operatively
Fluids administered to the mother per operatively
in milliliters
Time frame: Per operative period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dose of ephedrine administered to the mother per operatively
in milligrams
Time frame: Per operative period
Ramsay score for sedation
Ranging from 1 to 6
Time frame: 24 hours post operatively