Multimodal Pain Study in Free Flap Patients

NCT04246697 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 00025711
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be 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.

Conditions

Head and Neck Cancer; Analgesia

Outcome Measures

Primary Outcomes (2)

• Mean Morphine Equivalents During Stay

  Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them.

  Duration of their initial post-operative hospital stay as defined as the interval between index surgery to post-operative day 7.

• Mean Morphine Equivalents

  Mean morphine equivalents prescribed outpatient after index surgery. Will be calculated after converting all opioids to morphine equivalents and then averaging them.

  From day of index surgery to 1 year post-operatively.

Secondary Outcomes (4)

• Length of Stay

  At end of stay, number of post-operative days spent in the hospital was recorded for each patient.

• Number of Patients With Post-operative Complications

  Analyze the first 7 post-operative days to confirm number of patients with post-operative complications

• Patient Pain Percentage Compared to Baseline

  Pain level collected every 2 to 4 hours while inpatient. Daily pain percentage values were first averaged for each patient and then across all patients within each arm.

• Patient Pain Assessment Percentage

  Daily. The ABC pain scale will be given once daily for the patient to fill out for the first seven days.

Study Arms (2)

Standard of Care A

ACTIVE COMPARATOR

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; Drug: Oxycodone; Drug: Morphine

Standard of Care B

EXPERIMENTAL

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; Drug: Oxycodone; Drug: Morphine; Drug: Gabapentin; Drug: toradol; Drug: Bupivacaine

Interventions

Tylenol DRUG

Used for both arms, scheduled

Standard of Care A; Standard of Care B

Oxycodone DRUG

Used for both arms PRN

Standard of Care A; Standard of Care B

Morphine DRUG

Used for both arms PRN

Standard of Care A; Standard of Care B

Gabapentin DRUG

Used for Arm B

Standard of Care B

toradol DRUG

Used for Arm B

Standard of Care B

Bupivacaine DRUG

Used for Arm B - anesthesia block

Standard of Care B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Agnosia

Interventions

Acetaminophen; Oxycodone; Morphine; Gabapentin; Ketorolac Tromethamine; Bupivacaine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring

Results Point of Contact

• Title: Yelizaveta Shnayder
• Organization: University of Kansas medical Center

yshnayder@kumc.edu

913-588-6701

Study Officials

• Lisa Shnayder, MD

  KUMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: January 29, 2020
• Study Start: November 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: May 1, 2023
• Last Updated: July 7, 2026
• Results First Posted: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)