Post-Operative Pain Control in Opioid Tolerant Patients: Fentanyl Challenge Protocol Versus Standard of Care

October 30, 2015 updated by: Jose Raul Monzon, M.D., Bassett Healthcare
This study will evaluate the value of dosing pain medications based upon a patient's pre-operative tolerance to pain medications. Study participants will be assigned to one of two groups, a treatment group and a control group. The treatment group will be given pain medications after surgery based upon their measured response to pain medications prior to surgery. The control group will be given pain medications based upon the normal dosing routine as is currently practiced. Both groups will be closely monitored for side effects and have their pain scores recorded for the first 48 hours following surgery.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This study will focus on patients who are opioid-tolerant pre-operatively, a patient population which typically has both higher pain scores and more complications related to analgesics than opioid naïve patients. Currently, there is no standardized system for determining an adequate pain control regimen for a patient post-operatively. At this institution, pain medications are dosed per physician preference. The most widely-discussed method for calculating tolerance to opioids relies on converting a patient's daily opioid consumption to a morphine equivalent dose and basing a pain regimen upon that number. This method does not account for variability of response to different medications or dosing forms however. It would be advantageous to have a method of dosing opioid pain medications in this population that is both safe and effective.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Cooperstown, New York, United States, 13326
        • Bassett Healthcare Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age > 18
  2. Anticipated need for PCA dosing post-operatively
  3. Will undergo major general, plastic, vascular, thoracic or spine surgery
  4. Have taken opioid medications orally or transdermally daily for the past 30 days

Exclusion Criteria:

  1. Patients assessed to have a difficult airway
  2. Known sensitivity or allergy to fentanyl

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fentanyl Challenge Dosing

In the operating room a fentanyl infusion will be started at 2 mcg/kg/min. The time from start of the infusion to respiratory depression(rate < 5 breaths/minute) will be used to calculate the effect-site concentration (Ce).Using the pharmacodynamic model calculated by the Stanpump PCA software, the infusion will continue intraoperatively to achieve a fentanyl Ce of 30%. In the Post Anesthesia Care Unit (PACU), the rate would be changed with the following parameters:

  1. 50% of the hourly dose is given as a basal infusion
  2. The remainder of the hourly dose is ordered as a demand dose q 15 minutes. Post-operatively, the basal rate is adjusted according to the average demand dose use. In patients using < 1 demand dose per hour, the basal rate is decreased by 20%. In patients using > 3 demand doses per hour, the basal rate is increased by 20%. Patients whose pain cannot be managed by this protocol will be removed from the study and pain management will revert to the primary service.
Drug: Fentanyl
Fentanyl Patient Controlled Analgesia for post-operative pain management
Other Names:
  • Versed
Active Comparator: Standard of Care (Control)
Patients in the best practice arm would receive pre-operative sedation in the operating room comparable to the dose normally given in the Ambulatory Surgery Unit as a "simulated fentanyl challenge". Best practice (control) patients will be followed by the Pain & Palliative Care team in order to make adjustments in pain management as required by the patients.
Drug: Fentanyl
Fentanyl Patient Controlled Analgesia for post-operative pain management
Other Names:
  • Versed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: 48 hours post-operatively
Patients will rate their pain on a scale of 1-10 (1 being best, 10 being worst)
48 hours post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: 24 hours post-operatively
Patients will rate their pain on a scale of 1-10 (1 being best, 10 being worst)
24 hours post-operatively
Events requiring intervention for respiratory depression
Time Frame: 48 hours post-operatively
All adverse events will be documented including administration of naloxone, prompting to take more frequent breaths by staff and respiratory rate less than 8 per minute
48 hours post-operatively
Number of dose adjustments required
Time Frame: 48 hours post-operatively
Study will record the number of dose adjustments required to maintain adequate pain control
48 hours post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bassett Healthcare

Investigators

  • Principal Investigator: jose Monzon, MD, Bassett Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

December 19, 2014

First Submitted That Met QC Criteria

December 19, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1064

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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