Pre-emptive Paracetamol for Prevention of Intraoperative Shoulder Tip Pain

NCT ID: NCT04038307

Last Updated: 2020-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-02-01

Brief Summary

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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

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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 .

Conditions

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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control

will receive 100 ml of saline

Group Type PLACEBO_COMPARATOR

Saline Solution

Intervention Type DRUG

100ml

paracetamol group

will receive 1gm paracetamol (100ml)

Group Type EXPERIMENTAL

paracetamol

Intervention Type DRUG

1gm

Interventions

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paracetamol

1gm

Intervention Type DRUG

Saline Solution

100ml

Intervention Type DRUG

Eligibility Criteria

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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
* 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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Yasmin Hassab elnaby

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of medicine

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MS-12-2019

Identifier Type: -

Identifier Source: org_study_id

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