Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Acetaminophen Intravenous
* Drug: Acetaminophen Oral


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parturients 18 years Elective Cesarean delivery Spinal anesthesia Able to consent to the study and participate in the follow-up. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acetaminophen Intravenous<br>(group 1) 1 gram IV acetaminophen every 8 hours for three doses | Drug: Acetaminophen Intravenous<br>* IV 1 gram f3 doses over 24 hours<br>* Other names: Tylenol;|
| Active Comparator: Acetaminophen Oral<br>(group 2) 1 gram oral acetaminophen every 8 hours for three doses | Drug: Acetaminophen Oral<br>* Oral 1 gram 3 doses over 24 hours<br>* Other names: Tylenol;|
| No Intervention: No acetaminophen<br>(group 3) no acetaminophen | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Postoperative Opiate Consumption | Cumulative opiate consumption (IV morphine equivalents) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Opiate Rescue | Time to first opiate pain medicine requested by patient | 48 hours | 
| VAS (Visual Analog Scale) | 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]) . | 24 hours | 
| Time Discharge | Time patient meets discharge criteria will be recorded | 24 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acetaminophen, Pain, Postoperative, Analgesia, Obstetrical, Cesarean Section