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

NCT02804633 | Completed DMC

• 1 other identifier: JH 13-04
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain Control Post Colorectal Surgery

Keywords

IV acetaminophen; Colorectal Surgery; Enhance Recovery; Opioid Consumption; Pain Management

Outcome Measures

Primary Outcomes (2)

• Total opioid consumption

  48 hours

• pain control base on pain visual Analogue Scale Score (1-10)

  48 hours

Secondary Outcomes (4)

• 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

Study Arms (2)

IV acetaminophen group

ACTIVE COMPARATOR

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

IV Acetaminophen DRUG

1 gram every 6 hours

IV acetaminophen group

Placebo DRUG

100 ml of normal saline every 6 hours

Placebo Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jewish Hospital, Cincinnati, Ohio: lead

MeSH Terms

Conditions

Agnosia

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 17, 2016
• Study Start: August 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 17, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share