NCT04038307

Brief Summary

the aim is to determine the efficacy of Paracetamol in reducing the incidence and severity of intraoperative shoulder pain in patients undergoing cesarean section.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 24, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

July 24, 2019

Last Update Submit

January 22, 2020

Conditions

Cesarean Section

Keywords

shoulder tip pain

Outcome Measures

Primary Outcomes (1)

  • incidence shoulder tip pain

    presence of shoulder tip pain

    intraoperative

Secondary Outcomes (1)

  • numerical rating scale

    intraoperative

Study Arms (2)

control

PLACEBO COMPARATOR

will receive 100 ml of saline

Drug: Saline Solution

paracetamol group

EXPERIMENTAL

will receive 1gm paracetamol (100ml)

Drug: paracetamol

Interventions

paracetamolDRUG

1gm

paracetamol group
Saline SolutionDRUG

100ml

control

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy pregnant women (ASA II) having singleton pregnancy at term (≤ 37 weeks of gestation) aged between 18 and 40 years.

You may not qualify if:

  • Patients having allergy to study drug,
  • gestational diabetes
  • cardiovascular or biliary disorders
  • asthma
  • renal impairment
  • preeclampsia
  • any chronic pain condition or trauma in the shoulder, forearms or upper limbs
  • patients with any contraindication to SA were excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Cairo, Egypt

Location

MeSH Terms

Interventions

AcetaminophenSaline Solution

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 24, 2019

First Posted

July 30, 2019

Study Start

August 1, 2019

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)