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Clinical Trials/NCT04038307
NCT04038307
Unknown
Phase 2

Pre-emptive Intravenous Paracetamol for Prevention of Intraoperative Shoulder Tip Pain in Patients Undergoing Caesarean Section: A Randomized Double Blind Controlled Clinical Trial.

Cairo University1 site in 1 country120 target enrollmentAugust 1, 2019

Overview

Phase
Phase 2
Intervention
Saline Solution
Conditions
Cesarean Section
Sponsor
Cairo University
Enrollment
120
Locations
1
Primary Endpoint
incidence shoulder tip pain
Last Updated
6 years ago

Overview

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.

Detailed Description

pregnant females scheduled for cesarean section under spinal anesthesia will be enrolled . two groups of patents will be recruited . the study group will receive paracetamol pre operative .

Registry
clinicaltrials.gov
Start Date
August 1, 2019
End Date
February 1, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yasmin Hassab elnaby

principal investigator

Cairo University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Patients having allergy to study drug,
  • gestational diabetes
  • cardiovascular or biliary disorders
  • 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.

Arms & Interventions

control

will receive 100 ml of saline

Intervention: Saline Solution

paracetamol group

will receive 1gm paracetamol (100ml)

Intervention: paracetamol

Outcomes

Primary Outcomes

incidence shoulder tip pain

Time Frame: intraoperative

presence of shoulder tip pain

Secondary Outcomes

  • numerical rating scale(intraoperative)

Study Sites (1)

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