CompletedNCT02804633DOCIVAUpdated Jun 17, 2016

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

An interventional study of IV Acetaminophen and Placebo in Pain Control Post Colorectal Surgery, sponsored by Jewish Hospital, Cincinnati, Ohio. Completed. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-17.

Sponsored by Jewish Hospital, Cincinnati, Ohio · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 105
Allocation: Randomized
Ages: 18 Years to 90 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Pain Control Post Colorectal Surgery

Browse trials for

Agnosia 1,269

Keywords

IV acetaminophen
Colorectal Surgery
Enhance Recovery
Opioid Consumption
Pain Management

In context

Agnosia

1,269 studies on the registry are indexed under Agnosia; 524 are open to participants now.

This study's enrollment of 105 is above the median of 75 across 1,089 interventional studies indexed under Agnosia.

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Lead sponsor

Jewish Hospital, Cincinnati, Ohio is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 90 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 105 participants (actual)

Study arms

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
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

Interventions

DrugIV Acetaminophen
1 gram every 6 hours
DrugPlacebo
100 ml of normal saline every 6 hours

What researchers measure

Primary outcomes

Total opioid consumption
Time frame: 48 hours
pain control base on pain visual Analogue Scale Score (1-10)
Time frame: 48 hours

Secondary outcomes

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

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2013, a primary completion of Mar 2015 and a completion of Mar 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 8, 2016
First posted: Jun 17, 2016
Start: Aug 2013
Primary completionActual: Mar 2015
CompletionActual: Mar 2015
Last update: Jun 17, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02804633
Lead sponsor: Jewish Hospital, Cincinnati, Ohio
Responsible party: Amir H. Aryaie (MD, Jewish Hospital, Cincinnati, Ohio) — Principal investigator
First posted: Jun 17, 2016
Start date: Aug 2013
Primary completion: Mar 2015
Completion: Mar 2015
Last update: Jun 17, 2016

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Acetaminophen

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