Postoperative Pain
Conditions
Keywords
postoperative pain, pregabalin, cesarean section
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.
Interventions
DRUGPregabalin 150mg
two capsules, one is placebo, the other correspond to pregabalin 150 mg ingested orally one hour before cesarean section
DRUGPlacebos
two capsules filled with sugar ingested orally one hour before cesarean section
DRUGPregabalin 300mg
two capsules of pregabalin 150 mg ingested orally one hour before cesarean section
Sponsors
Hôpital Universitaire Fattouma Bourguiba
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first analgesic request | 24 hours | in minutes, the time between the end of the operation to the first demand of analgesics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal satisfaction | 24 hours | Measured by a Visual Analog Scale, ranging from 0 to 100; 0=not satisfied at all |
| Maternal consumption of paracetamol postoperatively | 24 hours | grams |
| Apgar scores | 1 and 5 minutes after birth | Ranging from 0 to 10; 7 to 10 correspond to an excellent condition |
| Heart rate | Per operative period | beats per minute |
| Visual analog scale (VAS) at rest and movement | 24 hours | Checked at hours 2, 4, 6,12,18 and 24 post operatively |
| Visual disturbances | 24 hours post operatively | present or not |
| 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 |
| Ramsay score for sedation | 24 hours post operatively | Ranging from 1 to 6 |
| Non-invasive blood pressure | Per operative period | measured in millimeters of mercury |
Countries
Tunisia
Outcome results
None listed