RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Cesarean Pain Relief

Phase 4CompletedNCT02046382

TriHealth Inc.132 enrolled

Overview

This study is being done to evaluate the scheduled use of intravenous (IV) acetaminophen among cesarean section patients. The study hopes to find out if patients who receive scheduled IV acetaminophen for 48 hours following delivery have lower self-reported pain scores and use less narcotic pain medication than patients who do not receive IV acetaminophen.

See Brief Summary

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

132

Conditions

Cesarean Section Pain, Postoperative

Interventions

IV AcetaminophenDRUG

1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

PlaceboDRUG

100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age greater than or equal to 18 years * Scheduled cesarean section delivery * Patient of TriHealth's Faculty Medical Center or Tri-State Maternal Fetal Medicine Associates * Singleton pregnancy * Term delivery (greater than or equal to 37 weeks) * Spinal/epidural anesthesia with epidural analgesia (duramorph) * Use of pfannenstiel incision Exclusion Criteria: * Weight less than 50 kg * Allergy to study drugs (acetaminophen, oxycodone, duramorph, NSAIDS) * Multiple gestation pregnancy * Cesarean section for pre-term delivery (less than 37 weeks) * Fetal anomalies * Inability to use epidural duramorph at time of procedure * General anesthesia used * Vertical skin incision * Opioid addiction * Liver dysfunction (hepatitis, HELLP (hemolysis, elevated liver enzymes, and low platelet count), preeclampsia)

Locations (1)

TriHealth Good Samaritan Hospital

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Total Oxycodone (mg)

Total oxycodone (mg) for breakthrough pain during inpatient stay

Time frame: approximately 2 - 7 days

Secondary Outcomes

Number of Participants With Narcotic Associated Side Effects

Only outcome for nausea/emesis is reported.

Time frame: 2-7 days

Length of Stay

Length of hospital stay (admission to discharge) will be collected.

Time frame: 2-7 days

Data from ClinicalTrials.gov

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