Pain ManagementPhase 4NCT03121963
Pain Management in Head and Neck Surgery Patients
A Phase 4 study testing Oxycodone, Acetaminophen and Gabapentin in people with Pain Management, run by University of Alabama at Birmingham.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Pain Management
- What is being tested?
- Oxycodone, Acetaminophen and Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2017to 6 Nov 2021
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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).
Read the detailed description
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.
- Conditions
- Pain Management
- Being tested
- Oxycodone, Acetaminophen, Gabapentin, Celecoxib, Hydrocodone-Acetaminophen
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Also called Oxycontin
oxycodone tablet
AcetaminophenDrug
Also called Tylenol
acetaminophen tablet
GabapentinDrug
Also called Neurontin
gabapentin tablet
CelecoxibDrug
Also called Celebrex
celecoxib tablet
Hydrocodone-AcetaminophenDrug
Also called Norco
hydrocodone 5 mg/acetaminophen 325 mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 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. Receives: Drug: Oxycodone; Drug: Acetaminophen; Drug: Gabapentin; Drug: Celecoxib |
| Control Group | Active comparator | A single medication regimen of hydrocodone-acetaminophen 7.5 mg Q6hr PRN post-operatively x 2 weeks. Receives: Drug: Hydrocodone-Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant pain control
Self-report via questionnaire of pain score, pain improvement, average pain, location of pain, and interference with daily activities
Measured: 2 weeks
Secondary outcomes (1)
Opioid medication use
Amount of opioid medication used, based on pill count
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study start10 Nov 2017
- Primary completion6 Nov 2020
- Study completion6 Nov 2021 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Partington, University of Alabama at Birmingham
- Investigators
- Erin Partington Buczek, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121963
- Sponsor's protocol ID
- IRB-170310004
- Status last verified
- Jun 2021
- First submitted
- 17 Apr 2017
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share individual participant data for this protocol.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management in Head and Neck Surgery Patients
- ClinicalTrials.gov ID
- NCT03121963
- Acronym / sponsor ID
- IRB-170310004
- Conditions
- Pain Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2021 (estimated)
- First posted
- 20 Apr 2017 (actual)
- 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.
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).
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Oxycodone, Drug: Acetaminophen, Drug: Gabapentin, Drug: CelecoxibA 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 comparator | Drug: Hydrocodone-AcetaminophenA single medication regimen of hydrocodone-acetaminophen 7.5 mg Q6hr PRN post-operatively x 2 weeks. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| OxycodoneAlso: Oxycontinoxycodone tablet | Drug | Treatment Group |
| AcetaminophenAlso: Tylenolacetaminophen tablet | Drug | Treatment Group |
| GabapentinAlso: Neurontingabapentin tablet | Drug | Treatment Group |
| CelecoxibAlso: Celebrexcelecoxib tablet | Drug | Treatment Group |
| Hydrocodone-AcetaminophenAlso: Norcohydrocodone 5 mg/acetaminophen 325 mg tablet | Drug | Control Group |
Primary outcome
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
1 secondary outcome
Opioid medication use
Time frame: 2 weeks
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 22 Jun 2021.
- Individual participant dataSharing planned: No. There is no current plan to share individual participant data for this protocol.
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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.
Erin Partington Buczek, MD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone, Acetaminophen and Gabapentin in people with Pain Management, run by University of Alabama at Birmingham.
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 3 inclusion and 4 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 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Participant pain control (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2021.