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

Sponsor
Hôpital Universitaire Fattouma Bourguiba (Other)
Overall Status
Completed
CT.gov ID
NCT04259073
Collaborator
(none)
138
Enrollment
1
Location
3
Arms
7.3
Actual Duration (Months)
18.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Pregabalin 150mg
  • Drug: Placebos
  • Drug: Pregabalin 300mg
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
138 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Does Pregabalin Improve Post-operative Pain After C-section Delivery
Actual Study Start Date :
Mar 1, 2018
Actual Primary Completion Date :
Jun 30, 2018
Actual Study Completion Date :
Oct 10, 2018

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Group C

two capsules filled with sugar

Drug: Placebos
two capsules filled with sugar ingested orally one hour before cesarean section
Other Names:
  • C

    		•
    Active Comparator: Group P150

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

    Drug: Pregabalin 150mg
    two capsules, one is placebo, the other correspond to pregabalin 150 mg ingested orally one hour before cesarean section
    Other Names:
  • P150

    		•
    Active Comparator: Group P300

    two capsules of pregabalin (150 mg)

    Drug: Pregabalin 300mg
    two capsules of pregabalin 150 mg ingested orally one hour before cesarean section
    Other Names:
  • P300

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to first analgesic request [24 hours]

      in minutes, the time between the end of the operation to the first demand of analgesics

    Secondary Outcome Measures

    1. Visual analog scale (VAS) at rest and movement [24 hours]

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

    2. Maternal satisfaction [24 hours]

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

    3. Maternal consumption of paracetamol postoperatively [24 hours]

      grams

    4. Apgar scores [1 and 5 minutes after birth]

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

    5. Heart rate [Per operative period]

      beats per minute

    6. Non-invasive blood pressure [Per operative period]

      measured in millimeters of mercury

    7. Visual disturbances [24 hours post operatively]

      present or not

    8. Fluids administered to the mother per operatively [Per operative period]

      in milliliters

    9. Dose of ephedrine administered to the mother per operatively [Per operative period]

      in milligrams

    10. Ramsay score for sedation [24 hours post operatively]

      Ranging from 1 to 6

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Monastir maternity and neonatology center Monastir Tunisia 5000

    Sponsors and Collaborators

    • Hôpital Universitaire Fattouma Bourguiba

    Investigators

    • Principal Investigator: Malek Khemili, Resident, Fattouma Bourguiba Hospital ICU

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Khemili Malek, Principal investigator, Hôpital Universitaire Fattouma Bourguiba
    ClinicalTrials.gov Identifier:
    NCT04259073
    Other Study ID Numbers:
    • KMalek
    First Posted:
    Feb 6, 2020
    Last Update Posted:
    Feb 6, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Khemili Malek, Principal investigator, Hôpital Universitaire Fattouma Bourguiba
    postoperative pain
    pregabalin
    cesarean section
    Additional relevant MeSH terms:
    Pain, Postoperative
    Pregabalin

    Study Results

    No Results Posted as of Feb 6, 2020