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CompletedNCT02369133Updated Feb 23, 2015

Preemptive Analgesia With Intravenous Paracetamol for Post-cesarean Section Pain Control

A Phase 4 interventional study of paracetamol and Placebo in Cesarean Section; Dehiscence, sponsored by Baskent University. Completed. Open to female participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-23.

Sponsored by Baskent University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Female
01

Study summary

The investigators designed a prospective randomized study to investigate the efficacy of intravenous (IV) preemptive paracetamol on postoperative pain scores, patient satisfaction, total morfin consumption and the incidence of morfin-related side effects in patients undergoing cesarean section.

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Conditions studied

  • Cesarean Section; Dehiscence
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In context

Lead sponsor

Baskent University is the lead sponsor of 209 studies on the registry; 35 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients between the ages of 20-40 years,
  • ASA physical status 1-2 who underwent elective cesarean surgery during general anesthesia were included in the study

Exclusion criteria

Exclusion Criteria:

  • A history of allergy to any of the study medications (opiod, general anesthetic agents or paracetamol),
  • history of opioid or paracetamol use,
  • hepatic or renal failure,
  • any psychological disorders,
  • complications during cesarean section and unable to use PCIA device were excluded from the study.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Group Paracetamol (Group P),

    Drugs were given intravenously by a nurse unaware of the study 15 min before surgery. Patients in group P (n = 30) received 1 g iv paracetamol

    Drug: paracetamol

  • Placebo comparator
    Group Saline (Group S)

    Drugs were given intravenously by a nurse unaware of the study 15 min before surgery. Patients in group S (n = 30) received 100 ml iv %0,9 saline

    Drug: Placebo

Interventions

  • Drugparacetamol

    Drugs were given intravenously by a nurse unaware of the study 15 min before surgery. Patients in group P (n = 30) received 1 g iv paracetamol, patients in group S (n = 30) received 100 ml iv %0.9 NaCl

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Postoperative pain scores measured by visual analog scale (VAS)

    Time frame: Postoperative 24 hours

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02369133
Lead sponsor
Baskent University
Responsible party
Ozlem Ozmete (Medical Doctor, Baskent University) — Principal investigator
First posted
Feb 23, 2015
Start date
Nov 2013
Primary completion
Feb 2014
Completion
Nov 2014
Last update
Feb 23, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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