NCT04259073

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

February 3, 2020

Last Update Submit

February 4, 2020

Conditions

Postoperative Pain

Keywords

postoperative painpregabalincesarean section

Outcome Measures

Primary Outcomes (1)

  • Time to first analgesic request

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

    24 hours

Secondary Outcomes (10)

  • Visual analog scale (VAS) at rest and movement

    24 hours

  • Maternal satisfaction

    24 hours

  • Maternal consumption of paracetamol postoperatively

    24 hours

  • Apgar scores

    1 and 5 minutes after birth

  • Heart rate

    Per operative period

  • +5 more secondary outcomes

Study Arms (3)

Group C

PLACEBO COMPARATOR

two capsules filled with sugar

Drug: Placebos

Group P150

ACTIVE COMPARATOR

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

Drug: Pregabalin 150mg

Group P300

ACTIVE COMPARATOR

two capsules of pregabalin (150 mg)

Drug: Pregabalin 300mg

Interventions

Pregabalin 150mgDRUG

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

Also known as: P150
Group P150
PlacebosDRUG

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

Also known as: C
Group C
Pregabalin 300mgDRUG

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

Also known as: P300
Group P300

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists class I or II
  • single pregnancies at term
  • under spinal anesthesia

You may not qualify if:

  • conversion to general anesthesia
  • post partum hemorrhage requiring specific resuscitation
  • local anesthetic toxicity
  • violation of the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Monastir maternity and neonatology center

Monastir, 5000, Tunisia

Location

Related Publications (2)

  • 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.

    PMID: 26718698BACKGROUND

  • 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.

    PMID: 30583095BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

PregabalinFocal Adhesion Protein-Tyrosine KinasesE1A-Associated p300 Protein

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsProtein-Tyrosine KinasesProtein KinasesPhosphotransferases (Alcohol Group Acceptor)PhosphotransferasesTransferasesEnzymesEnzymes and CoenzymesIntracellular Signaling Peptides and ProteinsProteinsp300-CBP Transcription FactorsHistone AcetyltransferasesLysine AcetyltransferasesAcetyltransferasesAcyltransferasesTranscription Factors

Study Officials

  • Malek Khemili, Resident

    Fattouma Bourguiba Hospital ICU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 6, 2020

Study Start

March 1, 2018

Primary Completion

June 30, 2018

Study Completion

October 10, 2018

Last Updated

February 6, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

principal outcomes measured in the study

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
March 2020 for one year
Access Criteria
after request by mailing

Locations

TU(1)