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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. Identifier: NCT03121963
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : February 27, 2019
Information provided by (Responsible Party):
Erin Partington, University of Alabama at Birmingham

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).

Condition or disease Intervention/treatment Phase
Pain Management Drug: Oxycodone Drug: Acetaminophen Drug: Gabapentin Drug: Celecoxib Drug: Hydrocodone-Acetaminophen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.
Drug: Oxycodone
oxycodone tablet
Other Name: Oxycontin

Drug: Acetaminophen
acetaminophen tablet
Other Name: Tylenol

Drug: Gabapentin
gabapentin tablet
Other Name: Neurontin

Drug: Celecoxib
celecoxib tablet
Other Name: Celebrex

Active Comparator: Control Group
A single medication regimen of hydrocodone-acetaminophen 7.5 mg Q6hr PRN post-operatively x 2 weeks.
Drug: Hydrocodone-Acetaminophen
hydrocodone 5 mg/acetaminophen 325 mg tablet
Other Name: Norco

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Opioid medication use [ Time Frame: 2 weeks ]
    Amount of opioid medication used, based on pill count

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03121963

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Contact: Norma Miller, RN 205-934-9714

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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Norma Miller, RN    205-934-9714   
Sponsors and Collaborators
University of Alabama at Birmingham
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Principal Investigator: Erin Partington Buczek, MD University of Alabama at Birmingham

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Responsible Party: Erin Partington, Principal Investigator, University of Alabama at Birmingham Identifier: NCT03121963    
Other Study ID Numbers: IRB-170310004
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no current plan to share individual participant data for this protocol.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Acetaminophen, hydrocodone drug combination
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents