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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01231191
Recruitment Status : Withdrawn (study not funded)
First Posted : November 1, 2010
Last Update Posted : March 8, 2012
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Intraoperative and Postoperative Opioid Requirements Drug: Intravenous acetaminophen Drug: Intravenous placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Relationship Between Intraoperative Intravenous Acetaminophen and Postoperative Opioid Avoidance for Ambulatory Surgical Procedures

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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. [ Time Frame: Day of Surgery ]

Secondary Outcome Measures :
  1. A secondary endpoint for this investigation will be the total dose of fentanyl administered to the patient. [ Time Frame: Day of Surgery ]
  2. A secondary outcome for this investigation will be the total dose of morphine administered to the patient. [ Time Frame: Day of Surgery ]
  3. A secondary outcome for this investigation will be the total dose of ibuprophen administered to the patient. [ Time Frame: Day of Surgery ]
  4. A secondary outcome measure for this investigation will be the total dose of oxycodone administered to the patient. [ Time Frame: Day of Surgery ]
  5. A secondary outcome measure will be any surgeon-administered local anesthetics used for wound infiltration. [ Time Frame: Day of Surgery ]
  6. A secondary outcome measure for this study will be any recovery-room anti-emetics administered to the patient. [ Time Frame: Day of Surgery ]
  7. 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. [ Time Frame: Day of Surgery ]
  8. 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. [ Time Frame: Day of Surgery ]
  9. Adverse events [ Time Frame: Up to one year postoperative ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231191


Locations
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United States, California
UCSD Medical Center (Hillcrest and Thornton)
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Mallinckrodt
Investigators
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Principal Investigator: Brian M Ilfeld, M.D., M.S. University of California, San Diego

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Responsible Party: Brian M. Ilfeld, MD, MS, Associate Professor, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01231191    
Other Study ID Numbers: IV Acetaminophen
First Posted: November 1, 2010    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics