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

NCT02324933 | Withdrawn Phase 4

• 1 other identifier: 1064
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Pain Score

  Patients will rate their pain on a scale of 1-10 (1 being best, 10 being worst)

  48 hours post-operatively

Secondary Outcomes (3)

• Pain Score

  24 hours post-operatively

• Events requiring intervention for respiratory depression

  48 hours post-operatively

• Number of dose adjustments required

  48 hours post-operatively

Study Arms (2)

Fentanyl Challenge Dosing

EXPERIMENTAL

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

Standard of Care (Control)

ACTIVE COMPARATOR

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

Interventions

Fentanyl DRUG

Fentanyl Patient Controlled Analgesia for post-operative pain management

Also known as: Versed

Fentanyl Challenge Dosing; Standard of Care (Control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients assessed to have a difficult airway
• Known sensitivity or allergy to fentanyl

Sponsors & Collaborators

• Bassett Healthcare: lead

Study Sites (1)

Bassett Healthcare Network

Cooperstown, New York, 13326, United States

Location

Related Publications (1)

• Davis JJ, Swenson JD, Hall RH, Dillon JD, Johnson KB, Egan TD, Pace NL, Niu SY. Preoperative "fentanyl challenge" as a tool to estimate postoperative opioid dosing in chronic opioid-consuming patients. Anesth Analg. 2005 Aug;101(2):389-395. doi: 10.1213/01.ANE.0000156563.25878.19.

  PMID: 16037150 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Fentanyl; Midazolam

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• jose Monzon, MD

  Bassett Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician - general surgery

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 24, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2016
• Last Updated: November 2, 2015

Record last verified: 2015-10

Locations

US (1)