Pre-emptive Paracetamol for Prevention of Intraoperative Shoulder Tip Pain

Cesarean Section Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04038307
• Other study ID #: MS-12-2019
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: August 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: January 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Drug:
• paracetamol
1gm
• Saline Solution
100ml

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence shoulder tip pain	presence of shoulder tip pain	intraoperative
Secondary	numerical rating scale	severity of shoulder tip pain (0-10) where 0 is no pain and 10 is the worst pain ever	intraoperative