Decrease Opioid Consumption With Intra-Venous (IV) Acetaminophen After Colorectal Surgery (DOCIVA) (DOCIVA)

Decreased Opioid Consumption and Enhance Recovery With the Addition of IV-Acetaminophen in Colorectal Patients: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Study

The investigators hypothesis is that use of IV acetaminophen will significantly decrease use of post-operative opioid consumption and enhances recovery after colorectal surgery.

Study Overview

• Status: Completed
• Conditions: Pain Control Post Colorectal Surgery
• Intervention / Treatment: Drug: IV Acetaminophen; Drug: Placebo

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 acetaminophen (1 gram) or placebo is given 30 minutes prior to operation and every 6 hours thereafter for up to 5 days post-operatively or discharge.

The investigators primary endpoint is to evaluate opioid consumption during the patient's hospital stay. The investigators secondary endpoints are to evaluate return of gastrointestinal function (ROGIF), time to diet ordered (TTDO), length of hospital stay (LOHS) and occurrence of ileus. Pain is measured with the pain visual analog scale score (PVASS) at 3, 8, 24 and 48 hours.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: IV acetaminophen group; In addition to PCA (morphine or hydromorphone) all patients receive 1 gram of IV acetaminophen (100 ml ) 30 minutes prior to operation and every 6 hours thereafter for up to 5 days post-operatively or discharge.	Drug: IV Acetaminophen; 1 gram every 6 hours
PLACEBO_COMPARATOR: Placebo Group; In addition to PCA (morphine or hydromorphone) all patients received placebo (100 ml normal saline) given 30 minutes prior to operation and every 6 hours thereafter for up to 5 days post-operatively or discharge	Drug: Placebo; 100 ml of normal saline every 6 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total opioid consumption	48 hours
pain control base on pain visual Analogue Scale Score (1-10)	48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
time to Return of GI function (ROGIF) [Flatus or bowel movement]	through study completion, an average of 5 days
Time to diet ordered (TTDO)	through study completion, an average of 5 days
Length of hospital stay (LOHS)	through study completion, an average of 5 days
Occurrence of ileus	through study completion, an average of 5 days

Collaborators and Investigators

• Sponsor: Jewish Hospital, Cincinnati, Ohio

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: June 8, 2016
• First Submitted That Met QC Criteria: June 14, 2016
• First Posted (ESTIMATE): June 17, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): June 17, 2016
• Last Update Submitted That Met QC Criteria: June 14, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Opioid Consumption; Pain Management; Colorectal Surgery; IV acetaminophen; Enhance Recovery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: JH 13-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES