Multimodal Pain Study in Free Flap Patients (NCT04246697) | Clinical Trial Compass
CompletedPhase 4
Multimodal Pain Study in Free Flap Patients
United States30 participantsStarted 2019-11-01
Plain-language summary
This study will be fashioned as a randomized, prospective study comparing Pain Management Arm A and Pain Management Arm B. Arm A will have scheduled Tylenol with opioids available as needed (PRN) in the peri-operative period. Arm B will undergo scheduled Gabapentin, Ketorolac and Tylenol as well as the Anesthesiology team managing regional nerve blocks, with opioids available PRN in the peri-operative period. The amount of pain medication used by all patients will be recorded as well as pain scores documented on a pain scale (0-10 with 0 indicating no pain and 10 indicating worst pain ever) as well as ABC pain scale throughout the patients' hospital stay. Morphine equivalents for the opioids will be calculated for each arm while observing pain scores. Then, the investigators will compare these two groups to see if there is a difference in opioid pain medication used. The study team's hypothesis is that the use of Gabapentin, Ketorolac, and Tylenol in combination will significantly reduce (at least 30% of Mean Morphine Equivalents - MME) the use of opioid medication for patients undergoing head and neck free flap reconstruction with similar to improved pain scores.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients over the age of 18 who are seen in the Department of Otolaryngology-Head and Neck Surgery clinic.
* Patients with a new H\&N cancer diagnosis undergoing primary surgery (free flap) for their cancer treatment.
Exclusion Criteria:
* Prior treatment for head and neck cancer.
* Planned treatment with primary radiation or chemoradiation for their head and neck cancer.
* Pregnant or lactating women.
* Patients with a history of consistent or regular opioid use for greater than six months used pre-operatively.
* Chronic gabapentin, pregabalin, and other non-opioid pain medication use pre-operatively.
* Diagnoses with fibromyalgia, anxiety disorder and other pain syndromes.
* Patients with documented history of kidney or liver disease.
* Patients with pre-operative lab values concerning for kidney/liver disease such as increased creatinine or liver function tests.
* Patients with a history of a serious GI bleed, CAD, or history of ischemic stroke .
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean morphine equivalents for Arm A
Timeframe: During the study period of approximately 1 year
2
Mean morphine equivalents for Arm B
Timeframe: During the study period of approximately 1 year