Does Pregabalin Improve Post-operative Pain After C-section Delivery
- Conditions
- Postoperative Pain
- Interventions
- Registration Number
- NCT04259073
- Lead Sponsor
- Hôpital Universitaire Fattouma Bourguiba
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 138
- American Society of Anesthesiologists class I or II
- single pregnancies at term
- under spinal anesthesia
- conversion to general anesthesia
- post partum hemorrhage requiring specific resuscitation
- local anesthetic toxicity
- violation of the protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Group C Placebos two capsules filled with sugar Group P300 Pregabalin 300mg two capsules of pregabalin (150 mg) Group P150 Pregabalin 150mg two capsules; one of them containing sugar (like the placebo one), the other is the active drug (pregabalin 150 mg)
- Primary Outcome Measures
Name Time Method Time to first analgesic request 24 hours in minutes, the time between the end of the operation to the first demand of analgesics
- Secondary Outcome Measures
Name Time Method Visual disturbances 24 hours post operatively present or not
Visual analog scale (VAS) at rest and movement 24 hours Checked at hours 2, 4, 6,12,18 and 24 post operatively
Maternal satisfaction 24 hours Measured by a Visual Analog Scale, ranging from 0 to 100; 0=not satisfied at all
Heart rate Per operative period beats per minute
Maternal consumption of paracetamol postoperatively 24 hours grams
Ramsay score for sedation 24 hours post operatively Ranging from 1 to 6
Apgar scores 1 and 5 minutes after birth Ranging from 0 to 10; 7 to 10 correspond to an excellent condition
Non-invasive blood pressure Per operative period measured in millimeters of mercury
Fluids administered to the mother per operatively Per operative period in milliliters
Dose of ephedrine administered to the mother per operatively Per operative period in milligrams
Trial Locations
- Locations (1)
Monastir maternity and neonatology center
🇹🇳Monastir, Tunisia
Monastir maternity and neonatology center🇹🇳Monastir, Tunisia