Study Stopped
This protocol was difficult to enroll into, and changes to personnel have made it difficult to main this study. Data collection was not completed and therefore, no data analysis was performed. The PI has made the decision to close this study.
Pain Management in Head and Neck Surgery Patients
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
Our study aims to see if the addition of a scheduled non-opioid pain regimen will decrease the use and risk of opioid pain medications as well as improve pain control in head and neck surgery patients. Participants will be randomized to one of two pain regimens (opioid medication regimen vs combination regimen of opioid and non-opioid medications).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2017
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2017
CompletedFirst Posted
Study publicly available on registry
April 20, 2017
CompletedStudy Start
First participant enrolled
November 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2021
CompletedJune 22, 2021
June 1, 2021
3 years
April 17, 2017
June 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Participant pain control
Self-report via questionnaire of pain score, pain improvement, average pain, location of pain, and interference with daily activities
2 weeks
Secondary Outcomes (1)
Opioid medication use
2 weeks
Study Arms (2)
Treatment Group
EXPERIMENTALA 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.
Control Group
ACTIVE COMPARATORA single medication regimen of hydrocodone-acetaminophen 7.5 mg Q6hr PRN post-operatively x 2 weeks.
Interventions
hydrocodone 5 mg/acetaminophen 325 mg tablet
Eligibility Criteria
You may qualify if:
- age 18-69
- able to consent for themselves
- undergoing a "moderate" head and neck surgery at UAB, defined as procedures that generally require only 1-2 night stay in the hospital. For the purposes of this protocol, this will include patients undergoing neck dissections, glossectomy with primary closure, thyroidectomy, or parotidectomy
You may not qualify if:
- age \< 18 or \> 69
- unable to consent for themselves
- have a known opioid tolerance or are one a home opioid regimen prior to surgery
- known hepatic failure, renal failure, or sulfa allergy, as determined by standard of care labs drawn within 30 days of enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erin Partington Buczek, MD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 17, 2017
First Posted
April 20, 2017
Study Start
November 10, 2017
Primary Completion
November 6, 2020
Study Completion
November 6, 2021
Last Updated
June 22, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share
There is no current plan to share individual participant data for this protocol.