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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
Pregabalin 150mg
Placebos
Pregabalin 300mg
Sponsored by
Hôpital Universitaire Fattouma Bourguiba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring postoperative pain, pregabalin, cesarean section

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Monastir maternity and neonatology center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Group C

Group P150

Group P300

Arm Description

two capsules filled with sugar

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

two capsules of pregabalin (150 mg)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Visual analog scale (VAS) at rest and movement
Checked at hours 2, 4, 6,12,18 and 24 post operatively
Maternal satisfaction
Measured by a Visual Analog Scale, ranging from 0 to 100; 0=not satisfied at all
Maternal consumption of paracetamol postoperatively
grams
Apgar scores
Ranging from 0 to 10; 7 to 10 correspond to an excellent condition
Heart rate
beats per minute
Non-invasive blood pressure
measured in millimeters of mercury
Visual disturbances
present or not
Fluids administered to the mother per operatively
in milliliters
Dose of ephedrine administered to the mother per operatively
in milligrams
Ramsay score for sedation
Ranging from 1 to 6

Full Information

First Posted
February 3, 2020
Last Updated
February 4, 2020
Sponsor
Hôpital Universitaire Fattouma Bourguiba
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1. Study Identification

Unique Protocol Identification Number
NCT04259073
Brief Title
Does Pregabalin Improve Post-operative Pain After C-section Delivery
Official Title
Does Pregabalin Improve Post-operative Pain After C-section Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
October 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Universitaire Fattouma Bourguiba

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
postoperative pain, pregabalin, cesarean section

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
two capsules filled with sugar
Arm Title
Group P150
Arm Type
Active Comparator
Arm Description
two capsules; one of them containing sugar (like the placebo one), the other is the active drug (pregabalin 150 mg)
Arm Title
Group P300
Arm Type
Active Comparator
Arm Description
two capsules of pregabalin (150 mg)
Intervention Type
Drug
Intervention Name(s)
Pregabalin 150mg
Other Intervention Name(s)
P150
Intervention Description
two capsules, one is placebo, the other correspond to pregabalin 150 mg ingested orally one hour before cesarean section
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
C
Intervention Description
two capsules filled with sugar ingested orally one hour before cesarean section
Intervention Type
Drug
Intervention Name(s)
Pregabalin 300mg
Other Intervention Name(s)
P300
Intervention Description
two capsules of pregabalin 150 mg ingested orally one hour before cesarean section
Primary Outcome Measure Information:
Title
Time to first analgesic request
Description
in minutes, the time between the end of the operation to the first demand of analgesics
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Visual analog scale (VAS) at rest and movement
Description
Checked at hours 2, 4, 6,12,18 and 24 post operatively
Time Frame
24 hours
Title
Maternal satisfaction
Description
Measured by a Visual Analog Scale, ranging from 0 to 100; 0=not satisfied at all
Time Frame
24 hours
Title
Maternal consumption of paracetamol postoperatively
Description
grams
Time Frame
24 hours
Title
Apgar scores
Description
Ranging from 0 to 10; 7 to 10 correspond to an excellent condition
Time Frame
1 and 5 minutes after birth
Title
Heart rate
Description
beats per minute
Time Frame
Per operative period
Title
Non-invasive blood pressure
Description
measured in millimeters of mercury
Time Frame
Per operative period
Title
Visual disturbances
Description
present or not
Time Frame
24 hours post operatively
Title
Fluids administered to the mother per operatively
Description
in milliliters
Time Frame
Per operative period
Title
Dose of ephedrine administered to the mother per operatively
Description
in milligrams
Time Frame
Per operative period
Title
Ramsay score for sedation
Description
Ranging from 1 to 6
Time Frame
24 hours post operatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malek Khemili, Resident
Organizational Affiliation
Fattouma Bourguiba Hospital ICU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monastir maternity and neonatology center
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
26718698
Citation
El Kenany S, El Tahan MR. Effect of preoperative pregabalin on post-caesarean delivery analgesia: a dose-response study. Int J Obstet Anesth. 2016 May;26:24-31. doi: 10.1016/j.ijoa.2015.11.001. Epub 2015 Nov 12.
Results Reference
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PubMed Identifier
30583095
Citation
Felder L, Saccone G, Scuotto S, Monks DT, Carvalho JCA, Zullo F, Berghella V. Perioperative gabapentin and post cesarean pain control: A systematic review and meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2019 Feb;233:98-106. doi: 10.1016/j.ejogrb.2018.11.026. Epub 2018 Dec 12.
Results Reference
background

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

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