NCT02714179

Brief Summary

The investigators designed a prospective randomized study to investigate the efficacy of intravenous (IV) preemptive versus preventive paracetamol on postoperative pain scores, patient satisfaction, total morphine consumption and the incidence of morphine-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
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2015

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

May 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
Last Updated

March 21, 2016

Status Verified

March 1, 2016

Enrollment Period

8 months

First QC Date

March 14, 2016

Last Update Submit

March 16, 2016

Conditions

Cesarean Section; Dehiscence

Outcome Measures

Primary Outcomes (1)

  • Visual analog score (VAS) for pain

    24 hours

Study Arms (2)

Group Preemptive (Group PE),

ACTIVE COMPARATOR

Group I: i.V. paracetamol 1 g (100 ml) was given 30 min before induction of anesthesia.

Drug: Paracetamol was given intravenously in both group at different times

Group Preventive (Group PV),

ACTIVE COMPARATOR

Group II: i.V. paracetamol 1 g (100 ml) was given before the end of surgery.

Drug: Paracetamol was given intravenously in both group at different times

Interventions

Paracetamol was given intravenously in both group at different timesDRUG
Group Preemptive (Group PE),Group Preventive (Group PV),

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • weeks pregnancy, elective cesarean section.

You may not qualify if:

  • morbid obesity, cardiac failure, depression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

March 14, 2016

First Posted

March 21, 2016

Study Start

May 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

March 21, 2016

Record last verified: 2016-03