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

Phase 4

Completed

• Conditions: Cesarean Section; Pain, Postoperative
• Interventions: Drug: Placebo; Drug: IV Acetaminophen

• Registration Number: NCT02046382
• Lead Sponsor: TriHealth Inc.

Brief Summary

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.

Detailed Description

See Brief Summary

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-23
• Study First Posted: 2014-01-27
• Primary Completion: 2016-12
• Study Completion: 2017-05
• Results First Submitted: 2017-11-03
• Results First Submitted QC: 2017-12-26
• Results First Posted: 2018-01-23
• Status Verified: 2018-02
• Last Update Submitted: 2018-07-19
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 132

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Placebo	Subjects will receive a 100mL dose of saline 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.
IV Acetaminophen	IV Acetaminophen	Subjects will receive a 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.

Primary Outcome Measures

Name	Time	Method
Total Oxycodone (mg)	approximately 2 - 7 days	Total oxycodone (mg) for breakthrough pain during inpatient stay

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Narcotic Associated Side Effects	2-7 days	Only outcome for nausea/emesis is reported.
Length of Stay	2-7 days	Length of hospital stay (admission to discharge) will be collected.

Trial Locations

Locations (1)

TriHealth Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States