Ketamine in Colorectal Surgery

Summary

This study will evaluate the effectiveness of ketamine infusions in the management of acute pain following open or laparoscopic colorectal surgery cases. Half of patients will receive the institutional standard of care and a placebo infusion (no active medication). The other half of patients will receive the institutional standard of care and a ketamine infusion. All subjects and staff will be blinded as to whether they are receiving placebo or ketamine.

Conditions

• Acute Pain
• Pain, Postoperative
• Colorectal Surgery

Interventions

DRUG

Placebo

Individuals enrolled into the control arm of the trial will receive a normal saline placebo infusion at a rate equivalent to the dosage of ketamine in the experimental arm.

DRUG

Ketamine

All individuals randomized to the experimental arm of the trial will receive ketamine therapy at a rate of 2 mcg/kg/hr dosed based on ideal body weight.

DRUG

Acetaminophen

All patients admitted to the hospital will be placed on scheduled acetaminophen 1000mg PO q 6 hours unless signs of liver disease/impairment or creatinine clearance \< 35ml/min at which point dosage would be reduced to 650mg q 8 hours. Individuals unable to take oral medications would be placed on intravenous acetaminophen.

DRUG

Opioid

All individuals will receive as needed opiate therapy as an adjunct to the scheduled medications and "ketamine/placebo" solution. Choice in opiate therapy will be at the discretion of the attending faculty. Dosage and adjustments will be in accordance with the institutional policy on appropriate opiate dosage adjustment.

DRUG

Alvimopan

All patients enrolled into the trial will be screened for eligibility for alvimopan utilization. Only in circumstances where patients are not on outpatient opioid medications and where they have not received any at time of arrival will alvimopan be administered. It will be given at least 30 minutes prior to surgery.

Sponsors & Collaborators

• Medical College of Wisconsin

  lead OTHER

Principal Investigators

• Thomas W Carver, MD · Medical College of Wisconsin

• Carrie Y Peterson, MD · Medical College of Wisconsin

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-31

Primary Completion

2017-08-31

Completion

2018-08-31

Countries

• United States

Study Locations