NCT04038307UnknownPhase 2
Pre-emptive Intravenous Paracetamol for Prevention of Intraoperative Shoulder Tip Pain in Patients Undergoing Caesarean Section: A Randomized Double Blind Controlled Clinical Trial.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Cairo University
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- incidence shoulder tip pain
Study 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 .
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Placebo Comparator
will receive 100 ml of saline
Intervention: Saline Solution (Drug)
paracetamol group
Experimental
will receive 1gm paracetamol (100ml)
Intervention: paracetamol (Drug)
Outcomes
Primary Outcomes
incidence shoulder tip pain
Time Frame: intraoperative
presence of shoulder tip pain
Secondary Outcomes
- numerical rating scale(intraoperative)
Investigators
Yasmin Hassab elnaby
principal investigator
Cairo University
Study Sites (1)
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