Status:
COMPLETED
Decrease Opioid Consumption With Intra-Venous (IV) Acetaminophen After Colorectal Surgery (DOCIVA)
Lead Sponsor:
Jewish Hospital, Cincinnati, Ohio
Conditions:
Pain Control Post Colorectal Surgery
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
The investigators hypothesis is that use of IV acetaminophen will significantly decrease use of post-operative opioid consumption and enhances recovery after colorectal surgery.
Detailed Description
All patients undergoing laparoscopic and open colorectal surgery are randomized to receive either IV acetaminophen or placebo. All patients received an opioid patient controlled anesthesia (PCA). IV a...
Eligibility Criteria
Inclusion
- Patient undergoing colorectal operation (Hartmann's procedure, sigmoidectomy, left hemicolectomy, right hemicolectomy, transverse colectomy, ileocecectomy, colo-colonic anastomosis, colorectal anastomosis, ileo-colonic anastomosis, low anterior resection, or abdominoperineal resection)
- Age range from 18 to 90 years old
- Patient providing signed, written informed consent before participation in the study
Exclusion
- Patient younger than 18 years old or older than 90 years old
- Patient or family is unable to give consent
- Patient who use opioids or tramadol daily for \>7 days before study medication administration(patient who, in the investigator's opinion, had or was developing opioid tolerance)
- Patient who had a chronic pain condition or any significant medical disease, laboratory abnormality, or condition that, in the investigator's judgment, could have compromised the subject's welfare, ability to communicate with the study staff, complete study activities, or otherwise restricted study participation
- Patient who had hypersensitivity to opioids, acetaminophen, or the inactive ingredients of the study medication
- Patient who had known or suspected history of alcohol or drug abuse or dependence within the previous 1 year
- Patient who had impaired liver function
- Patient who had fever within first 48 hours post-operatively and required acetaminophen for fever reduction
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT02804633
Start Date
August 1 2013
End Date
March 1 2015
Last Update
June 17 2016
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