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

Pain, Postoperative Clinical Trial

Official title:

Randomized Control Trial of IV Acetaminophen for Post Cesarean Delivery Pain Relief

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046382
• Other study ID #: 13068
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: May 2017

Study information

• Verified date: February 2018
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See Brief Summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cesarean Section
• Pain, Postoperative

Intervention

Drug:
• IV Acetaminophen
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.
• Placebo
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.

Locations

Country	Name	City	State
United States	TriHealth Good Samaritan Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total Amount of Ibuprofen During Inpatient Stay	Patients will have access to ibuprofen for mild to moderate pain. The amount consumed during inpatient stay will be collected.	2-7 days
Primary	Total Oxycodone (mg)	Total oxycodone (mg) for breakthrough pain during inpatient stay	approximately 2 - 7 days
Secondary	Number of Participants With Narcotic Associated Side Effects	Only outcome for nausea/emesis is reported.	2-7 days
Secondary	Length of Stay	Length of hospital stay (admission to discharge) will be collected.	2-7 days