Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Acetaminophen Intravenous; Drug: Acetaminophen Oral

• Registration Number: NCT02487303
• Lead Sponsor: Medical University of South Carolina

Brief Summary

This study will compare IV (intravenous) versus oral (PO) acetaminophen for postoperative pain after scheduled, elective Cesarean delivery. All patients will receive a standardized spinal anesthetic for operative anesthesia and will be randomized into one of three groups: (group 1) 1 gram IV acetaminophen every 8 hours for three doses, (group 2) 1 gram oral acetaminophen every 8 hours for three doses, or (group 3) no acetaminophen. This will be a randomized, open label study.

Detailed Description

This study will compare IV versus PO acetaminophen for postoperative pain in parturients after scheduled, elective Cesarean delivery. It is designed as a randomized, open label, controlled trial. All patients will receive a standardized spinal anesthetic for operative anesthesia and will be randomized into one of three groups: (group 1) 1 gram IV acetaminophen every 8 hours for three by a computer generated list.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-03-17
• Study First Submitted: 2015-06-25
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-07-01
• Primary Completion: 2017-07-27
• Study Completion: 2017-07-27
• Results First Submitted: 2018-07-30
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-05
• Last Update Submitted: 2018-11-05
• Results First Posted: 2018-12-05
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 148

Inclusion Criteria

• Parturients 18 years
• Elective Cesarean delivery
• Spinal anesthesia
• Able to consent to the study and participate in the follow-up.

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Exclusion Criteria

• Weight under 50 kgs
• Allergy to acetaminophen
• General anesthesia
• Urgent or emergent cases
• Bleeding diathesis or other coagulopathy
• G6PD deficiency
• Liver disease
• Substance abuse or dependence
• HELLP syndrome
• Thrombocytopenia or platelet dysfunction
• History or active gastrointestinal bleeding
• Acute kidney injury or chronic renal insufficiency
• Contraindication/refusal to spinal anesthesia
• Chronic pain
• Chronic narcotic use
• Illicit drug use
• Allergy to any study related medications.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetaminophen Intravenous	Acetaminophen Intravenous	(group 1) 1 gram IV acetaminophen every 8 hours for three doses
Acetaminophen Oral	Acetaminophen Oral	(group 2) 1 gram oral acetaminophen every 8 hours for three doses

Primary Outcome Measures

Name	Time	Method
Cumulative Postoperative Opiate Consumption	24 hours	Cumulative opiate consumption (IV morphine equivalents)

Secondary Outcome Measures

Name	Time	Method
Time to First Opiate Rescue	48 hours	Time to first opiate pain medicine requested by patient
VAS (Visual Analog Scale)	24 hours	Visual Analog Scale (VAS) pain assessment with ambulation. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\]) .
Time Discharge	24 hours postoperative	Time patient meets discharge criteria will be recorded

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States