Clinical trial NCT01231191: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Relationship Between Intraoperative Intravenous Acetaminophen and Postoperative Opioid Avoidance for Ambulatory Surgical Procedures
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Postoperative Pain
Intraoperative and Postoperative Opioid Requirements
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Cadence Pharmaceuticals
First posted: 2010-11-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: Day of Surgery
Secondary outcomes:
measure: A secondary endpoint for this investigation will be the total dose of fentanyl administered to the patient.
timeFrame: Day of Surgery
measure: A secondary outcome for this investigation will be the total dose of morphine administered to the patient.
timeFrame: Day of Surgery
measure: A secondary outcome for this investigation will be the total dose of ibuprophen administered to the patient.
timeFrame: Day of Surgery
measure: A secondary outcome measure for this investigation will be the total dose of oxycodone administered to the patient.
timeFrame: Day of Surgery
measure: A secondary outcome measure will be any surgeon-administered local anesthetics used for wound infiltration.
timeFrame: Day of Surgery
measure: A secondary outcome measure for this study will be any recovery-room anti-emetics administered to the patient.
timeFrame: Day of Surgery
measure: 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.
timeFrame: Day of Surgery
measure: 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.
timeFrame: Day of Surgery
measure: Adverse events
timeFrame: Up to one year postoperative
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Medical Center (Hillcrest and Thornton)
state: California
Study officials:
affiliation: University of California, San Diego
name: Brian M Ilfeld, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References: