IV Acetaminophen for Postoperative Analgesia

NCT01798316 | Terminated Phase 4 Results

• 2 other identifiers: 12-0409IRB #12-409B
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the use of IV acetaminophen for postoperative pain management after laparoscopic cholecystectomy to determine if its use to supplement standard of care pain management decreases the incidence of post-operative nausea and vomiting.

Conditions

Postoperative Pain; Postoperative Nausea; Postoperative Vomiting

Keywords

IV Acetaminophen; Laparoscopic cholecystectomy; Postoperative nausea; Postoperative vomiting

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Postoperative Nausea and Vomiting (PONV).

  Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay. PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching.

  4 hours plus/minus 30 minutes

Secondary Outcomes (4)

• Number of Participants With Post Discharge Nausea and Vomiting (PDNV)

  Up to two days following surgery

• Highest Pain Intensity Score Using Numeric Rating Scale (NRS)

  4 hours plus/minus 30 minutes

• Patient Satisfaction on a 5 Point Likert Scale

  Up to one week following surgery

• Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale

  1 hour following surgery

Other Outcomes (2)

• Number of Patients Requiring Rescue Analgesia for Breakthrough Pain

  1 hour following surgery

• Narcotic Use During PACU Stay

  4 hours plus/minus 30 minutes

Study Arms (2)

IV Acetaminophen

ACTIVE COMPARATOR

IV Acetaminophen administered on admission to post-anesthesia care unit

Drug: IV Acetaminophen

Standard of care

ACTIVE COMPARATOR

Standard of care pain management regimen including opioids administered on admission to post-anesthesia care unit

Drug: Standard of Care

Interventions

IV Acetaminophen DRUG

Single dose, 1000g mg infusion over 15 minutes plus standard of care pain management regimen

Also known as: Ofirmev

IV Acetaminophen

Standard of Care DRUG

Standard of care pain management regimen, no IV Acetaminophen,

Also known as: As per provider: Opioids

Standard of care

Eligibility Criteria

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

You may qualify if:

• Subject is undergoing pre-scheduled laparoscopic cholecystectomy;
• American Society of Anesthesiology patient classification status I-II

You may not qualify if:

• Regular preoperative use of or opioids,
• Subjects admitted after surgery for postoperative complications other than postoperative pain or PONV.
• Subjects converted to open laparoscopic cholecystectomy
• Known allergy/hypersensitivity to acetaminophen
• Use of opioids prior to commencement of the study (\<7 days)
• Patients with chronic pain conditions or disease requiring pain control
• Abnormal liver function
• Known or suspected alcohol, drug or opiate abuse or dependence
• Patients with a BMI of greater than 35
• Other physical, mental or medical conditions that could effect participation.
• Abnormal renal function; serum creatinine\>2gm/dl

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (3)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

Location

Syosset Hospital

Syosset, New York, 11791, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Acetaminophen; Standard of Care

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Director of Clinical Research, Department of Anesthesiology
• Organization: Northwell

odowling@northwell.edu

718-470-7630

Study Officials

• Frank J Overdyk, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 25, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 31, 2017
• Results First Posted: May 31, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)