Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery

Medical University of South Carolina148 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

148

Conditions

Pain, Postoperative

Interventions

Acetaminophen IntravenousDRUG

IV 1 gram f3 doses over 24 hours

Acetaminophen OralDRUG

Oral 1 gram 3 doses over 24 hours

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Cumulative Postoperative Opiate Consumption

Cumulative opiate consumption (IV morphine equivalents)

Time frame: 24 hours

Secondary Outcomes

Time to First Opiate Rescue

Time to first opiate pain medicine requested by patient

Time frame: 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 \[100-mm scale\]) .

Time frame: 24 hours

Time Discharge

Time patient meets discharge criteria will be recorded

Time frame: 24 hours postoperative

Data from ClinicalTrials.gov

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