NCT01231191

Brief Summary

This is a research study to determine if giving acetaminophen intravenously in hte operating room will decrease the number of patients who require additional pain medicine, such as morphine, after surgery in the recovery room.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2010

Completed
Last Updated

March 8, 2012

Status Verified

March 1, 2012

First QC Date

October 27, 2010

Last Update Submit

March 6, 2012

Conditions

Postoperative PainIntraoperative and Postoperative Opioid Requirements

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is the difference in proportions of patients from each treatment group who avoid using any opioids following anesthesia emergence until recovery room discharge.

    Day of Surgery

Secondary Outcomes (9)

  • A secondary endpoint for this investigation will be the total dose of fentanyl administered to the patient.

    Day of Surgery

  • A secondary outcome for this investigation will be the total dose of morphine administered to the patient.

    Day of Surgery

  • A secondary outcome for this investigation will be the total dose of ibuprophen administered to the patient.

    Day of Surgery

  • A secondary outcome measure for this investigation will be the total dose of oxycodone administered to the patient.

    Day of Surgery

  • A secondary outcome measure will be any surgeon-administered local anesthetics used for wound infiltration.

    Day of Surgery

  • +4 more secondary outcomes

Study Arms (2)

IV Acetaminophen

ACTIVE COMPARATOR

Intraoperative IV acetaminophen administered

Drug: Intravenous acetaminophen

IV Placebo

PLACEBO COMPARATOR

Intraoperative IV normal saline administered

Drug: Intravenous placebo

Interventions

Intravenous acetaminophenDRUG

Acetaminophen 1000 mg administered over 15 minutes intravenously as soon as feasible intraoperatively.

IV Acetaminophen
Intravenous placeboDRUG

Normal saline administered over 15 minutes intravenously as soon as feasible intraoperatively.

IV Placebo

Eligibility Criteria

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

You may qualify if:

  • Undergoing ambulatory surgery under general anesthesia
  • Expected postoperative pain to be mild-moderate
  • Age 18 years or older
  • Have an ASA physical status or 1, 2, or 3

You may not qualify if:

  • Anticipated peripheral or neuraxial nerve block
  • Any physical, mental or medical conditions which may confound quantifying postoperative pain resulting from surgery
  • Current chronic opioid or tramadol use
  • History of alcohol or opioid abuse
  • Known allergy to the study medications
  • Pregnancy
  • Any health condition requiring greater than 100 micrograms of fentanyl during anesthesia induction
  • Treated with any acetaminophen-containing medication in the previous 8 hours
  • Treated with MAO inhibitors within 10 days prior to surgery
  • Inability to communicate with the investigators and hospital staff
  • Known or impaired liver function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSD Medical Center (Hillcrest and Thornton)

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Brian M Ilfeld, M.D., M.S.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, In Residence

Study Record Dates

First Submitted

October 27, 2010

First Posted

November 1, 2010

Last Updated

March 8, 2012

Record last verified: 2012-03

Locations

US(1)