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

Primary Purpose

Cesarean Section, Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IV Acetaminophen
Placebo
Sponsored by
TriHealth Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cesarean Section focused on measuring IV Acetaminophen, Cesarean Section, Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • TriHealth Good Samaritan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IV Acetaminophen

Normal Saline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Total Oxycodone (mg)
Total oxycodone (mg) for breakthrough pain during inpatient stay

Secondary Outcome Measures

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

Full Information

First Posted
January 23, 2014
Last Updated
July 19, 2018
Sponsor
TriHealth Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02046382
Brief Title
RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Cesarean Pain Relief
Official Title
Randomized Control Trial of IV Acetaminophen for Post Cesarean Delivery Pain Relief
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriHealth Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Pain, Postoperative
Keywords
IV Acetaminophen, Cesarean Section, Pain, Postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IV Acetaminophen
Arm Type
Experimental
Arm Description
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.
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IV Acetaminophen
Other Intervention Name(s)
Ofirmev
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Oxycodone (mg)
Description
Total oxycodone (mg) for breakthrough pain during inpatient stay
Time Frame
approximately 2 - 7 days
Secondary Outcome Measure Information:
Title
Number of Participants With Narcotic Associated Side Effects
Description
Only outcome for nausea/emesis is reported.
Time Frame
2-7 days
Title
Length of Stay
Description
Length of hospital stay (admission to discharge) will be collected.
Time Frame
2-7 days
Other Pre-specified Outcome Measures:
Title
Total Amount of Ibuprofen During Inpatient Stay
Description
Patients will have access to ibuprofen for mild to moderate pain. The amount consumed during inpatient stay will be collected.
Time Frame
2-7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Lambers, MD
Organizational Affiliation
TriHealth Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
TriHealth Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28455085
Citation
Altenau B, Crisp CC, Devaiah CG, Lambers DS. Randomized controlled trial of intravenous acetaminophen for postcesarean delivery pain control. Am J Obstet Gynecol. 2017 Sep;217(3):362.e1-362.e6. doi: 10.1016/j.ajog.2017.04.030. Epub 2017 Apr 25.
Results Reference
derived

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

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