Multimodal Pain Study in Free Flap Patients

Multimodal Management for Perioperative Analgesia in Otolaryngology - Head and Neck Free Flap Reconstructive Surgery: A Prospective Study

This study will be fashioned as a randomized, prospective study comparing Pain Management Arm A and Pain Management Arm B. Arm A will have scheduled Tylenol with opioids available as needed (PRN) in the peri-operative period. Arm B will undergo scheduled Gabapentin, Ketorolac and Tylenol as well as the Anesthesiology team managing regional nerve blocks, with opioids available PRN in the peri-operative period. The amount of pain medication used by all patients will be recorded as well as pain scores documented on a pain scale (0-10 with 0 indicating no pain and 10 indicating worst pain ever) as well as ABC pain scale throughout the patients' hospital stay. Morphine equivalents for the opioids will be calculated for each arm while observing pain scores. Then, the investigators will compare these two groups to see if there is a difference in opioid pain medication used. The study team's hypothesis is that the use of Gabapentin, Ketorolac, and Tylenol in combination will significantly reduce (at least 30% of Mean Morphine Equivalents - MME) the use of opioid medication for patients undergoing head and neck free flap reconstruction with similar to improved pain scores.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Analgesia
• Intervention / Treatment: Drug: Tylenol; Drug: Oxycodone; Drug: Morphine; Drug: Gabapentin; Drug: toradol; Drug: Bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients over the age of 18 who are seen in the Department of Otolaryngology-Head and Neck Surgery clinic.
• Patients with a new H&N cancer diagnosis undergoing primary surgery (free flap) for their cancer treatment.

Exclusion Criteria:

• Prior treatment for head and neck cancer.
• Planned treatment with primary radiation or chemoradiation for their head and neck cancer.
• Pregnant or lactating women.
• Patients with a history of consistent or regular opioid use for greater than six months used pre-operatively.
• Chronic gabapentin, pregabalin, and other non-opioid pain medication use pre-operatively.
• Diagnoses with fibromyalgia, anxiety disorder and other pain syndromes.
• Patients with documented history of kidney or liver disease.
• Patients with pre-operative lab values concerning for kidney/liver disease such as increased creatinine or liver function tests.
• Patients with a history of a serious GI bleed, CAD, or history of ischemic stroke .

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care A; Randomized controlled prospective trial to compare two standards of care for head and neck surgery pain management. Arm A, will include: Scheduled Tylenol 1000 mg IV one time dose intra-operatively, then 650 mg via PEG tube or PO Q4H to a max dose of 4gm/24 hrs; Opioids prn based on Numeric Pain Scale (0-10, with 0 indicating no pain and 10 indicating worst pain ever):; 0-3: no prn meds, reassurance, listen to music, watch TV.; 4-7: Oxycodone 5 mg q4h prn via PEG tube or PO with a maximum of 30 mg/24 hours.; 8-10 Morphine 2 mg IV q2h prn breakthrough pain.	Drug: Tylenol; Used for both arms, scheduled; Drug: Oxycodone; Used for both arms PRN; Drug: Morphine; Used for both arms PRN
Experimental: Standard of Care B; Arm B, will include: Arm A description with addition..; Scheduled Ketorolac starting post-op day #1, 15 mg q6h (max 120 mg/day), for a total of 5 days; Scheduled Gabapentin starting 7 days preoperatively to continue postoperatively; Regional block per anesthesia protocol - Initial block: 0.5% bupivacaine, 20 ml Continuous infusion: 0.125% bupivacaine at 6 ml/hr with a 5 ml bolus available every 30 mins	Drug: Tylenol; Used for both arms, scheduled; Drug: Oxycodone; Used for both arms PRN; Drug: Morphine; Used for both arms PRN; Drug: Gabapentin; Used for Arm B; Drug: toradol; Used for Arm B; Drug: Bupivacaine; Used for Arm B - anesthesia block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean morphine equivalents for Arm A	Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them.	During the study period of approximately 1 year
Mean morphine equivalents for Arm B	Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them.	During the study period of approximately 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Length of stay in days	Analyze the first 7 post-operative days but take note of how long they stayed.
Post-operative complications	Monitor chart/EMR for bleeding, acute kidney injury, etc.	Analyze the first 7 post-operative days
Pain assessment for patients	Pain assessment will occur with nurses providing patient a 0-10 pain scale (i.e. 0 being the lowest and 10 being the greatest amount of pain) named the Defense Veterans Pain Rating Scale for each nursing assessment in order to know which pain medications to administer.	Nurses will use the DVPRS for each assessment while the patient is hospitalized, typically for seven days. Nursing assessments typically are Q2H-Q4H.
Pain assessment for patients	There is another pain assessment scale that will be distributed once daily to the patients to assess their pain and how it is affecting their functionality. This pain assessment/survey is named the ABC pain scale, which is a qualitative pain assessment.	The ABC pain scale will be given once daily for the patient to fill out for the first seven days.

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Lisa Shnayder, MD, KUMC

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; 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; Anesthetics; 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; Anesthetics, Local; Antimanic Agents; Gabapentin; Acetaminophen; Bupivacaine; Morphine; Oxycodone; Ketorolac Tromethamine
• Other Study ID Numbers: 00025711

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No