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Completed

NCT Number: NCT04259073

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

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Monastir maternity and neonatology center

Monastir, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregabalin 150mg

Drug

two capsules, one is placebo, the other correspond to pregabalin 150 mg ingested orally one hour before cesarean section

Other names: P150

Placebos

Drug

two capsules filled with sugar ingested orally one hour before cesarean section

Other names: C

Pregabalin 300mg

Drug

two capsules of pregabalin 150 mg ingested orally one hour before cesarean section

Other names: P300

Primary outcomes

  1. 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

  1. Visual analog scale (VAS) at rest and movement

    Time frame: 24 hours

    Checked at hours 2, 4, 6,12,18 and 24 post operatively

  2. Maternal satisfaction

    Time frame: 24 hours

    Measured by a Visual Analog Scale, ranging from 0 to 100; 0=not satisfied at all

  3. Maternal consumption of paracetamol postoperatively

    Time frame: 24 hours

    grams

  4. Apgar scores

    Time frame: 1 and 5 minutes after birth

    Ranging from 0 to 10; 7 to 10 correspond to an excellent condition

  5. Heart rate

    Time frame: Per operative period

    beats per minute

  6. Non-invasive blood pressure

    Time frame: Per operative period

    measured in millimeters of mercury

  7. Visual disturbances

    Time frame: 24 hours post operatively

    present or not

  8. Fluids administered to the mother per operatively

    Time frame: Per operative period

    in milliliters

  9. Dose of ephedrine administered to the mother per operatively

    Time frame: Per operative period

    in milligrams

  10. Ramsay score for sedation

    Time frame: 24 hours post operatively

    Ranging from 1 to 6

Sponsors and collaborators

Lead sponsor

Hôpital Universitaire Fattouma Bourguiba

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 6, 2020
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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