Clinical trial NCT02324933: Post-Operative Pain Control in Opioid Tolerant Patients: Fentanyl Challenge Protocol Versus Standard of Care
Official title: Post-Operative Pain Control in Opioid Tolerant Patients: Fentanyl Challenge Protocol Versus Standard of Care
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Bassett Healthcare
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Score
timeFrame: 48 hours post-operatively
Secondary outcomes:
measure: Pain Score
timeFrame: 24 hours post-operatively
measure: Events requiring intervention for respiratory depression
timeFrame: 48 hours post-operatively
measure: Number of dose adjustments required
timeFrame: 48 hours post-operatively
Other outcomes:
Locations:
city: Cooperstown
country: United States
facility: Bassett Healthcare Network
state: New York
Study officials:
affiliation: Bassett Healthcare
name: jose Monzon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.