Pain Management in Head and Neck Surgery Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03121963|
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : February 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain Management||Drug: Oxycodone Drug: Acetaminophen Drug: Gabapentin Drug: Celecoxib Drug: Hydrocodone-Acetaminophen||Phase 4|
Head and neck surgery patients have significant difficulty with pain control and the traditional opioid pain regimens can have increased risk in this patients population (namely, respiratory and airway compromise). Most of the literature for head and neck cancer patients focuses on pain management during chemoradiation therapy, but very few studies evaluate pain management in the post-operative setting. Patients with worse pain control and chronic opioid use do not score as well on quality of life questionnaires and have higher rates of depression and anxiety.
The few studies that did specifically evaluate post-operative pain showed success with a scheduled non-opioid management such as NSAIDs, acetaminophen, and gabapentin/pregabalin. In head and neck surgery patients, pre-operative gabapentin as compared to standard opioid pain medications was shown to have better pain control and less opioid requirements post operatively. Post-operative gabapentin has been studied and shows equivalent results, but has not been tested in a randomized controlled fashion and thus, more data is necessary. In another study evaluating scheduled acetaminophen vs as needed opioid pain medication in post-operative Cesarean section patients, there were similar results with improved pain control and less opioid use. NSAIDS are frequently avoided in post-surgical patients due to an increased risk of bleeding, but are frequently used in non-surgical patients and have shown significant benefit in pain control. Celecoxib is an NSAID that does not carry an increased bleeding risk and has been shown to be beneficial in pain control.
The pain management team in the UAB Department of Anesthesiology currently uses a combination regimen of opioid and non-opioid medication for their post-operative patients. This is the combination we plan to use in our treatment group. It consists of the standard dosing of oxycodone (an opioid) and acetaminophen, gabapentin and celecoxib (non-opioids) and is considered routine care for Anesthesiology's post-operative patients.
This study would be the first of its kind and potentially help determine a new post-operative pain management protocol for head and neck patients that is both more effective and less risky.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Pain Management in Head and Neck Surgery Patients|
|Actual Study Start Date :||November 10, 2017|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2020|
Experimental: Treatment Group
A combination regimen of oxycodone 5 mg Q6hr PRN, acetaminophen 650 mg Q6hr, celecoxib 400 mg BID post-operatively x 2 weeks, and gabapentin 400 mg loading dose, 300 mg TID to be started 1 week pre-operatively then continued post-operatively x 2 weeks.
Other Name: Oxycontin
Other Name: Tylenol
Other Name: Neurontin
Other Name: Celebrex
Active Comparator: Control Group
A single medication regimen of hydrocodone-acetaminophen 7.5 mg Q6hr PRN post-operatively x 2 weeks.
hydrocodone 5 mg/acetaminophen 325 mg tablet
Other Name: Norco
- Participant pain control [ Time Frame: 2 weeks ]Self-report via questionnaire of pain score, pain improvement, average pain, location of pain, and interference with daily activities
- Opioid medication use [ Time Frame: 2 weeks ]Amount of opioid medication used, based on pill count
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03121963
|Contact: Norma Miller, RNemail@example.com|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35233|
|Contact: Norma Miller, RN 205-934-9714 firstname.lastname@example.org|
|Principal Investigator:||Erin Partington Buczek, MD||University of Alabama at Birmingham|