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

Hôpital Universitaire Fattouma Bourguiba

Status: Completed

Conditions: Postoperative Pain

Treatments: Drug: Pregabalin 300mg; Drug: Placebos; Drug: Pregabalin 150mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04259073

KMalek

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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138 participants in 3 patient groups, including a placebo group

Group C

Placebo Comparator group

Description:

two capsules filled with sugar

Treatment:

Drug: Placebos

Group P150

Active Comparator group

Description:

two capsules; one of them containing sugar (like the placebo one), the other is the active drug (pregabalin 150 mg)

Treatment:

Drug: Pregabalin 150mg

Group P300

Active Comparator group

Description:

two capsules of pregabalin (150 mg)

Treatment:

Drug: Pregabalin 300mg