A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Relationship Between Intraoperative Intravenous Acetaminophen and Postoperative Opioid Avoidance for Ambulatory Surgical Procedures (Cadence)

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.

Study Overview

• Status: Withdrawn
• Conditions: Postoperative Pain; Intraoperative and Postoperative Opioid Requirements
• Intervention / Treatment: Drug: Intravenous acetaminophen; Drug: Intravenous placebo

Detailed Description

Primary Specific Aim: To determine if adding an intraoperative dose of intravenous acetaminphen to usual and customary analgesics during ambulatory surgery impacts the proportion of patients remaining opioid-free in the post-anesthesia recovery room.

Hypothesis: Adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during ambulatory surgery increases the proportion of patients remaining opioid-free in the post-anesthesia recovery room.

Secondary Specific Aim: To determine if adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during amublatory surgery impacts the required doses of additional perioperative analgesics.

Hypothesis: Adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during ambulatory surgery decreases the required doses of additional analgesics in both the operating room and post-anesthesia recovery room.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • UCSD Medical Center (Hillcrest and Thornton)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IV Acetaminophen; Intraoperative IV acetaminophen administered	Drug: Intravenous acetaminophen; Acetaminophen 1000 mg administered over 15 minutes intravenously as soon as feasible intraoperatively.
Placebo Comparator: IV Placebo; Intraoperative IV normal saline administered	Drug: Intravenous placebo; Normal saline administered over 15 minutes intravenously as soon as feasible intraoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
A secondary outcome measure for this study will be any recovery-room anti-emetics administered to the patient.	Day of Surgery
Patients will be asked at time of PACU discharge, "Overall, how would you rate the study treatments?" Responses will be on 0 to 3 scale where 0=poor and 3=excellent.	Day of Surgery
Patients will be asked at time of PACU discharge, "Overall, how would you rate the level of pain relief from study medication?" Responses will be on 0 to 3 scale where 0=poor and 3=excellent.	Day of Surgery
Adverse events	Up to one year postoperative

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Cadence Pharmaceuticals

Study record dates

Study Registration Dates

• First Submitted: October 27, 2010
• First Submitted That Met QC Criteria: October 29, 2010
• First Posted (Estimate): November 1, 2010

Study Record Updates

• Last Update Posted (Estimate): March 8, 2012
• Last Update Submitted That Met QC Criteria: March 6, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: IV Acetaminophen