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Completed

NCT Number: NCT02804633

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV acetaminophen

Drug

1 gram every 6 hours

Placebo

Drug

100 ml of normal saline every 6 hours

Primary outcomes

  1. Total opioid consumption

    Time frame: 48 hours

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

    Time frame: 48 hours

Secondary outcomes

  1. time to Return of GI function (ROGIF) [Flatus or bowel movement]

    Time frame: through study completion, an average of 5 days

  2. Time to diet ordered (TTDO)

    Time frame: through study completion, an average of 5 days

  3. Length of hospital stay (LOHS)

    Time frame: through study completion, an average of 5 days

  4. Occurrence of ileus

    Time frame: through study completion, an average of 5 days

Sponsors and collaborators

Lead sponsor

Jewish Hospital, Cincinnati, Ohio

Other

Registry information

Official study title

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

Acronym: DOCIVA

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 17, 2016
Registry last updated
Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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