NCT04259073

Does Pregabalin Improve Post-operative Pain After C-section Delivery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Hôpital Universitaire Fattouma Bourguiba · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Pregabalin 150mg	two capsules, one is placebo, the other correspond to pregabalin 150 mg ingested orally one hour before cesarean section
DRUG	Placebos	two capsules filled with sugar ingested orally one hour before cesarean section
DRUG	Pregabalin 300mg	two capsules of pregabalin 150 mg ingested orally one hour before cesarean section

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-06-30
• Completion: 2018-10-10
• First posted: 2020-02-06
• Last updated: 2020-02-06

Locations

1 site across 1 country: Tunisia