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

February 4, 2020 updated by: Khemili Malek, Hôpital Universitaire Fattouma Bourguiba

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
138

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Monastir, Tunisia, 5000
        • Monastir maternity and neonatology center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual analog scale (VAS) at rest and movement
Time Frame: 24 hours
Checked at hours 2, 4, 6,12,18 and 24 post operatively
24 hours
Maternal satisfaction
Time Frame: 24 hours
Measured by a Visual Analog Scale, ranging from 0 to 100; 0=not satisfied at all
24 hours
Maternal consumption of paracetamol postoperatively
Time Frame: 24 hours
grams
24 hours
Apgar scores
Time Frame: 1 and 5 minutes after birth
Ranging from 0 to 10; 7 to 10 correspond to an excellent condition
1 and 5 minutes after birth
Heart rate
Time Frame: Per operative period
beats per minute
Per operative period
Non-invasive blood pressure
Time Frame: Per operative period
measured in millimeters of mercury
Per operative period
Visual disturbances
Time Frame: 24 hours post operatively
present or not
24 hours post operatively
Fluids administered to the mother per operatively
Time Frame: Per operative period
in milliliters
Per operative period
Dose of ephedrine administered to the mother per operatively
Time Frame: Per operative period
in milligrams
Per operative period
Ramsay score for sedation
Time Frame: 24 hours post operatively
Ranging from 1 to 6
24 hours post operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hôpital Universitaire Fattouma Bourguiba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Malek Khemili, Resident, Fattouma Bourguiba Hospital ICU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KMalek

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

principal outcomes measured in the study

IPD Sharing Time Frame

March 2020 for one year

IPD Sharing Access Criteria

after request by mailing

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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