Does Pregabalin Improve Post-operative Pain After C-section Delivery
Overview
- Phase
- Not Applicable
- Intervention
- Placebos
- Conditions
- Postoperative Pain
- Sponsor
- Hôpital Universitaire Fattouma Bourguiba
- Enrollment
- 138
- Locations
- 1
- Primary Endpoint
- Time to first analgesic request
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Khemili Malek
Principal investigator
Hôpital Universitaire Fattouma Bourguiba
Eligibility Criteria
Inclusion Criteria
- •American Society of Anesthesiologists class I or II
- •single pregnancies at term
- •under spinal anesthesia
Exclusion Criteria
- •conversion to general anesthesia
- •post partum hemorrhage requiring specific resuscitation
- •local anesthetic toxicity
- •violation of the protocol
Arms & Interventions
Group C
two capsules filled with sugar
Intervention: Placebos
Group P150
two capsules; one of them containing sugar (like the placebo one), the other is the active drug (pregabalin 150 mg)
Intervention: Pregabalin 150mg
Group P300
two capsules of pregabalin (150 mg)
Intervention: Pregabalin 300mg
Outcomes
Primary Outcomes
Time to first analgesic request
Time Frame: 24 hours
in minutes, the time between the end of the operation to the first demand of analgesics
Secondary Outcomes
- Visual disturbances(24 hours post operatively)
- Visual analog scale (VAS) at rest and movement(24 hours)
- Maternal satisfaction(24 hours)
- Heart rate(Per operative period)
- Maternal consumption of paracetamol postoperatively(24 hours)
- Ramsay score for sedation(24 hours post operatively)
- Apgar scores(1 and 5 minutes after birth)
- Non-invasive blood pressure(Per operative period)
- Fluids administered to the mother per operatively(Per operative period)
- Dose of ephedrine administered to the mother per operatively(Per operative period)