NCT02046382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
9 months until next milestone

Results Posted

Study results publicly available

January 23, 2018

Completed
Last Updated

August 16, 2018

Status Verified

February 1, 2018

Enrollment Period

2.9 years

First QC Date

January 23, 2014

Results QC Date

November 3, 2017

Last Update Submit

July 19, 2018

Conditions

Cesarean SectionPain, Postoperative

Keywords

IV AcetaminophenCesarean SectionPain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Total Oxycodone (mg)

    Total oxycodone (mg) for breakthrough pain during inpatient stay

    approximately 2 - 7 days

Secondary Outcomes (2)

  • Number of Participants With Narcotic Associated Side Effects

    2-7 days

  • Length of Stay

    2-7 days

Other Outcomes (1)

  • Total Amount of Ibuprofen During Inpatient Stay

    2-7 days

Study Arms (2)

IV Acetaminophen

EXPERIMENTAL

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.

Drug: IV Acetaminophen

Normal Saline

PLACEBO COMPARATOR

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.

Drug: Placebo

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.

Also known as: Ofirmev
IV Acetaminophen
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.

Also known as: Normal Saline
Normal Saline

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TriHealth Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

  • 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.

    PMID: 28455085DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

AcetaminophenSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Clinical Research Specialist
Organization
TriHealth
ganga_devaiah@trihealth.com
513-862-2341

Study Officials

  • Donna Lambers, MD

    TriHealth Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2014

First Posted

January 27, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

May 1, 2017

Last Updated

August 16, 2018

Results First Posted

January 23, 2018

Record last verified: 2018-02

Locations

US(1)