Monastir maternity and neonatology center
Monastir, 5000, Tunisia
NCT Number: NCT04259073
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Monastir, 5000, Tunisia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
two capsules, one is placebo, the other correspond to pregabalin 150 mg ingested orally one hour before cesarean section
Other names: P150
two capsules filled with sugar ingested orally one hour before cesarean section
Other names: C
two capsules of pregabalin 150 mg ingested orally one hour before cesarean section
Other names: P300
Time frame: 24 hours
in minutes, the time between the end of the operation to the first demand of analgesics
Time frame: 24 hours
Checked at hours 2, 4, 6,12,18 and 24 post operatively
Time frame: 24 hours
Measured by a Visual Analog Scale, ranging from 0 to 100; 0=not satisfied at all
Time frame: 24 hours
grams
Time frame: 1 and 5 minutes after birth
Ranging from 0 to 10; 7 to 10 correspond to an excellent condition
Time frame: Per operative period
beats per minute
Time frame: Per operative period
measured in millimeters of mercury
Time frame: 24 hours post operatively
present or not
Time frame: Per operative period
in milliliters
Time frame: Per operative period
in milligrams
Time frame: 24 hours post operatively
Ranging from 1 to 6
Hôpital Universitaire Fattouma Bourguiba
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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