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Pre-emptive Paracetamol for Prevention of Intraoperative Shoulder Tip Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038307
Recruitment Status : Active, not recruiting
First Posted : July 30, 2019
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Yasmin Hassab elnaby, Cairo University

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.

Condition or disease Intervention/treatment Phase
Cesarean Section Drug: paracetamol Drug: Saline Solution Phase 2 Phase 3

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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pre-emptive Intravenous Paracetamol for Prevention of Intraoperative Shoulder Tip Pain in Patients Undergoing Caesarean Section: A Randomized Double Blind Controlled Clinical Trial.
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Placebo Comparator: control
will receive 100 ml of saline
Drug: Saline Solution
100ml

Experimental: paracetamol group
will receive 1gm paracetamol (100ml)
Drug: paracetamol
1gm




Primary Outcome Measures :
  1. incidence shoulder tip pain [ Time Frame: intraoperative ]
    presence of shoulder tip pain


Secondary Outcome Measures :
  1. numerical rating scale [ Time Frame: intraoperative ]
    severity of shoulder tip pain (0-10) where 0 is no pain and 10 is the worst pain ever



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038307


Locations
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Egypt
Faculty of medicine
Cairo, Egypt
Sponsors and Collaborators
Cairo University
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Responsible Party: Yasmin Hassab elnaby, principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT04038307    
Other Study ID Numbers: MS-12-2019
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yasmin Hassab elnaby, Cairo University:
shoulder tip pain
Additional relevant MeSH terms:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics