Pain Management in Head and Neck Surgery Patients

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).

Study Overview

• Status: Withdrawn
• Conditions: Pain Management
• Intervention / Treatment: Drug: Oxycodone; Drug: Acetaminophen; Drug: Gabapentin; Drug: Celecoxib; Drug: Hydrocodone-Acetaminophen

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 Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Oxycontin; Drug: Acetaminophen; acetaminophen tablet; Other Names: Tylenol; Drug: Gabapentin; gabapentin tablet; Other Names: Neurontin; Drug: Celecoxib; celecoxib tablet; Other Names: 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 Names: Norco

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid medication use	Amount of opioid medication used, based on pill count	2 weeks

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Erin Partington Buczek, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2017
• Primary Completion (Actual): November 6, 2020
• Study Completion (Anticipated): November 6, 2021

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (Actual): April 20, 2017

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Respiratory System Agents; Cyclooxygenase 2 Inhibitors; Antitussive Agents; Gabapentin; Celecoxib; Acetaminophen; Oxycodone; Hydrocodone; Acetaminophen, hydrocodone drug combination
• Other Study ID Numbers: IRB-170310004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no current plan to share individual participant data for this protocol.

Drug and device information, study documents

• 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