NCT02369133

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_4

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2015

Completed
Last Updated

February 23, 2015

Status Verified

February 1, 2015

Enrollment Period

3 months

First QC Date

February 17, 2015

Last Update Submit

February 20, 2015

Conditions

Cesarean Section; Dehiscence

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain scores measured by visual analog scale (VAS)

    Postoperative 24 hours

Study Arms (2)

Group Paracetamol (Group P),

ACTIVE COMPARATOR

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

Group Saline (Group S)

PLACEBO COMPARATOR

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

paracetamolDRUG

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

Group Paracetamol (Group P),
PlaceboDRUG
Group Saline (Group S)

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 17, 2015

First Posted

February 23, 2015

Study Start

November 1, 2013

Primary Completion

February 1, 2014

Study Completion

November 1, 2014

Last Updated

February 23, 2015

Record last verified: 2015-02