IV Acetaminophen for Acute Post Operative Pain in C-Section Patients

NCT02069184 | Completed Phase 4 Results DMC

• 1 other identifier: 13-07-144
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Post-operative pain management after C-section is an important topic as the number of elective c-sections increases each year. Pain is managed either by giving opioids or by using non-opioids. The purpose of this study is to evaluate the effectiveness of IV Acetaminophen in pain relief and its impact in the usage of post-operative opioid requirements and opioid associated complications. The hypothesis is that four doses of IV Acetaminophen in conjunction with intrathecal or epidural morphine given to the patients after c-section will reduce post-operative opioid requirements and opioid associated complications.

Conditions

Post-operative Pain

Keywords

opioid usage requirements; pain; IV acetaminophen; opioid usage; c-section

Outcome Measures

Primary Outcomes (1)

• Opioid Requirements in Cesarean Section (C-section) Patient Population

  24 and 48 hours after Cesarean Section

Secondary Outcomes (6)

• Visual Analog Score (VAS) Pain Score

  every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or up to 48 hours

• Percentage of Participants Reporting to be Wide Awake up to 72 Hours After the C-section

  Percentage of Participants Reporting to be Wide Awake up to 72 hours after the C-section

• "Percentage of Patients With Adverse Events After the Surgery

  every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or upto 72 hours. Finally, 1 week after discharge.

• Number of Participants Using Patient-controlled Analgesia (PCA) Attempts

  every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or upto 72 hours.

• Percentage of Participants That Were Re-Hospitalized 1 Week After Discharge

  From time of discharge to 1 week after discharge

Study Arms (2)

IV Acetaminophen

EXPERIMENTAL

IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours.

Drug: IV Acetaminophen

Saline as placebo

EXPERIMENTAL

IV form, total 4 units, each given every 6th hourly in 24 hours.

Other: Saline as placebo

Interventions

IV Acetaminophen DRUG

1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly

Also known as: IV Tylenol

IV Acetaminophen

Saline as placebo OTHER

100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly.

Saline as placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective full term CS patients
• Age 18 and above
• ASA I-III

You may not qualify if:

• Allergic reaction to IV acetaminophen
• Not able to understand and sign the research consent
• Pregnancy induced hypertension or pre-eclampsia patients
• Planned intensive care admission patients
• Patients with severe hepatic impairment or active liver diseases (Two fold increase in any of the liver enzymes)
• Patients with serum creatinine\>2mg/dl
• For nursing mothers, any evidence of hepatic dysfunction of the new born

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center- Weiler

The Bronx, New York, 10467, United States

Location

Related Publications (1)

• Bernstein J, Spitzer Y, Ohaegbulam K, Reddy S, Song J, Romanelli E, Nair S. The analgesic efficacy of IV acetaminophen for acute postoperative pain in C-section patients: a randomized, double-blind, placebo-controlled study. J Matern Fetal Neonatal Med. 2022 Mar;35(5):933-940. doi: 10.1080/14767058.2020.1735337. Epub 2020 Mar 10.

  PMID: 32156175 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Acetaminophen; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

There may be unknown factors that could have biased the results of the study, pain tolerance is not measured in this study, surgeon variation in performing the surgery and lack of standardized post -operative pain management protocol.

Results Point of Contact

• Title: Jeffrey Bernstein
• Organization: Montefiore Medical Center

JBernste@montefiore.org

718-920-4317

Study Officials

• Jeffrey Bernstein, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Prof, Anesthesiology

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: February 24, 2014
• Study Start: November 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 22, 2019
• Results First Posted: August 22, 2019

Record last verified: 2019-08

Locations

US (1)