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Head and Neck CancerPhase 4NCT04246697

Multimodal Pain Study in Free Flap Patients

A Phase 4 study testing Tylenol, Oxycodone and Morphine in people with Head and Neck Cancer and Analgesia, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer, Analgesia
What is being tested?
Tylenol, Oxycodone and Morphine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Nov 2019to 1 May 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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 .

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

Other trials in United States

About this study

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

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.

Read the detailed description

ABSTRACT

Objectives:

To apply implementation science principles to optimize the delivery of multimodal analgesia to patients undergoing major head and neck oncologic surgeries including free flap reconstruction, to reduce variability in opioid administration and decrease the need for opioids.

Methods:

A pilot prospective randomized controlled trial (RCT #1) followed by a hybrid type 1 effectiveness-implementation pragmatic randomized controlled trial (RCT #2).

RCT#1 included patients randomized to receive either scheduled acetaminophen and as needed opioids (control, Group 1) or scheduled acetaminophen, gabapentin, ketorolac, and as needed opioids (experimental, Group 2). The primary outcome was mean morphine milligram equivalents (MMEs) administered during the hospital stay. Secondary outcomes were hospital length of stay (LOS) and postoperative complications. We applied the principles of implementation science after identifying significant variability in healthcare professionals' approaches to administering opioids postoperatively during RCT#1.

RCT#2, a hybrid type 1 effectiveness-implementation pragmatic trial, was designed to test the effectiveness of the intervention and the penetrance of the implementation strategy. Arm A received standard regimen of scheduled acetaminophen and as needed opioids. Arm B received scheduled gabapentin, ketorolac, a regional nerve block at the free tissue donor site, scheduled acetaminophen and as needed opioids. Primary outcome was mean MMEs administered during the hospital stay (0-3 and 0-7 days). Secondary outcomes were LOS, complications, and functional pain scores (ABCs).

KEYWORDS: multimodal analgesia; head and neck; free flap reconstruction; dissemination and implementation

LEVEL OF EVIDENCE: 1B, Randomized Clinical Trial

Being tested
Tylenol, Oxycodone, Morphine, Gabapentin, toradol
Medical subject headings
Head and Neck Neoplasms, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TylenolDrug

    Used for both arms, scheduled

  • OxycodoneDrug

    Used for both arms PRN

  • MorphineDrug

    Used for both arms PRN

  • GabapentinDrug

    Used for Arm B

  • toradolDrug

    Used for Arm B

  • BupivacaineDrug

    Used for Arm B - anesthesia block

Study groups in NCT04246697
Study groupRoleWhat they receive
Standard of Care AActive comparatorRandomized 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.
Receives: Drug: Tylenol; Drug: Oxycodone; Drug: Morphine
Standard of Care BExperimentalArm 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
Receives: Drug: Tylenol; Drug: Oxycodone; Drug: Morphine; Drug: Gabapentin; Drug: toradol; Drug: Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Morphine Equivalents During Stay

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

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

  2. 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.

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

Secondary outcomes (4)

  1. Length of Stay

    Length of stay in days

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

  2. Number of Patients With Post-operative Complications

    Monitor chart/EMR for bleeding, acute kidney injury, etc.

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

  3. Patient Pain Percentage Compared to Baseline

    Pain was measured on a Likert scale from 0 to 10 (i.e. 0 being the lowest and 10 being the greatest amount of pain). Baseline pain (P0) was measured on this scale for each patient in the preoperative setting. Pain was similarly assessed at regular intervals post-operatively during hospitalization (Pn).

    Patient pain percentage was subsequently defined as follows:

    { 100*[(P_n/P_0) -1]│ n∈N, n≥1}

    Where:

    P_0: the baseline (initial) measurement taken at time t=0. P_n: the measurement taken at the nth time interval after baseline, where n∈N, n≥1

    Interpretation of "pain percentage compared to baseline":

    • A value of 0% indicates no change from baseline pain
    • Negative values indicate lower pain than baseline
    • Positive values indicate higher pain than baseline
    • Therefore, lower values represent a better outcome and higher values represent a worse outcome

    Measured: 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.

  4. Patient Pain Assessment Percentage

    Each of the domain of ABC pain index is weighted (mult_D) based on relative importance.

    For each domain D ∈{sleep, lying, sitting, oob, walk}, let:

    D_able∈{1,2,3}, (1 = able with pain; 2 = unable due to pain; 3 = unable for other reasons) D_pain∈[0, 5] (reported pain score)

    Then if:

    D_able = 1 numerator_D = D_pain × mult_D denominator_D = 1 +(5×mult_D) D_able=2 numerator_D = 1 + (5×mult_D) denominator_D= 1 + (5×mult_D ) D_able=3 numerator_D = 1 denominator_D = 1

    For the site-specific domains D ∈{h\&n,flap,graft}, let:

    D_present∈{1,2} (1=present; 2=absent) D_pain∈[0, 5] (reported pain score)

    Then if:

    D_present=1:

    numerator_D = D_pain × mult_D denominator_D = 5 × mult_D

    D_present=2:

    numerator_D = 0 denominator_D = 0

    Patient Pain Assessment Percentage:

    ABC_numerator = sum(numerator_D) ABC_denominator = sum(denominator_D) ABC_percentage = ABC_numerator / ABC_denominator This ranges from 0-100%. Lower values are better, higher values are worse.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2020
  2. Study start1 Nov 2019
  3. Primary completion1 Jun 2021
  4. Study completion1 May 2023

Resources

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
Double blind
Who is masked
Participant, Care provider
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04246697
Sponsor's protocol ID
00025711
Status last verified
Jun 2026
First submitted
31 Oct 2019
Last updated
7 Jul 2026
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tylenol, Oxycodone and Morphine in people with Head and Neck Cancer and Analgesia, run by University of Kansas Medical Center at 1 site in United States.

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 2 inclusion and 9 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: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 7 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Morphine Equivalents During Stay (time frame: Duration of their initial post-operative hospital stay as defined as the interval between index surgery to post-operative day 7.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04246697.

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 7 Jul 2026.

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