Pain, PostoperativePhase 4NCT02324933
Post-Operative Pain Control in Opioid Tolerant Patients: Fentanyl Challenge Protocol Versus Standard of Care
A Phase 4 study testing Fentanyl in people with Pain, Postoperative, run by Bassett Healthcare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients assessed to have a difficult airway
- Known sensitivity or allergy to fentanyl
Trial locations and contacts
1 site in 1 country.
United States1 site
Bassett Healthcare Network
Cooperstown, New York, 13326
About this study
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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- Fentanyl
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Versed
Fentanyl Patient Controlled Analgesia for post-operative pain management
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Patients will rate their pain on a scale of 1-10 (1 being best, 10 being worst)
Measured: 48 hours post-operatively
Secondary outcomes (3)
Pain Score
Patients will rate their pain on a scale of 1-10 (1 being best, 10 being worst)
Measured: 24 hours post-operatively
Events requiring intervention for respiratory depression
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
Measured: 48 hours post-operatively
Number of dose adjustments required
Study will record the number of dose adjustments required to maintain adequate pain control
Measured: 48 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startAug 2014
- Primary completionJan 2016 (estimated)
Why it stopped: insufficient population, unable to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bassett Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Raul Monzon, M.D., Bassett Healthcare
- Investigators
- jose Monzon, MD, Principal investigator, Bassett Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324933
- Sponsor's protocol ID
- 1064
- Status last verified
- Oct 2015
- First submitted
- 19 Dec 2014
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16037150
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Pain Control in Opioid Tolerant Patients: Fentanyl Challenge Protocol Versus Standard of Care
- ClinicalTrials.gov ID
- NCT02324933
- Acronym / sponsor ID
- 1064
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: insufficient population, unable to recruit
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bassett HealthcareUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jan 2016 (estimated)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl Challenge Dosing | Experimental | Drug: FentanylIn 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. |
| Standard of Care (Control) | Active comparator | Drug: FentanylPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients assessed to have a difficult airway
- Known sensitivity or allergy to fentanyl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylAlso: VersedFentanyl Patient Controlled Analgesia for post-operative pain management | Drug | Fentanyl Challenge Dosing, Standard of Care (Control) |
Primary outcome
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)
3 secondary outcomes
Pain Score
Time frame: 24 hours post-operatively
Events requiring intervention for respiratory depression
Time frame: 48 hours post-operatively
Number of dose adjustments required
Time frame: 48 hours post-operatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
- Background: PubMed 16037150Davis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jose Monzon, MD principal investigator
Bassett Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl in people with Pain, Postoperative, run by Bassett Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: 48 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02324933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2015.