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

Postoperative Pain Clinical Trial

— Cadence  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01231191
• Other study ID #: IV Acetaminophen
• Status: Withdrawn
• Phase: Phase 4
• First received: October 27, 2010
• Last updated: March 6, 2012

Study information

• Verified date: March 2012
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intraoperative and Postoperative Opioid Requirements
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Intravenous acetaminophen
Acetaminophen 1000 mg administered over 15 minutes intravenously as soon as feasible intraoperatively.
• Intravenous placebo
Normal saline administered over 15 minutes intravenously as soon as feasible intraoperatively.

Locations

Country	Name	City	State
United States	UCSD Medical Center (Hillcrest and Thornton)	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	A secondary endpoint for this investigation will be the total dose of fentanyl administered to the patient.		Day of Surgery	No
Secondary	A secondary outcome for this investigation will be the total dose of morphine administered to the patient.		Day of Surgery	No
Secondary	A secondary outcome for this investigation will be the total dose of ibuprophen administered to the patient.		Day of Surgery	No
Secondary	A secondary outcome measure for this investigation will be the total dose of oxycodone administered to the patient.		Day of Surgery	No
Secondary	A secondary outcome measure will be any surgeon-administered local anesthetics used for wound infiltration.		Day of Surgery	No
Secondary	A secondary outcome measure for this study will be any recovery-room anti-emetics administered to the patient.		Day of Surgery	No
Secondary	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	No
Secondary	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	No
Secondary	Adverse events		Up to one year postoperative	Yes