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Completed

NCT Number: NCT04246697

Multimodal Pain Study in Free Flap Patients

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.

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Key information

Conditions

Head and Neck Cancer Agnosia Analgesia Head and Neck Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Tylenol

Drug

Used for both arms, scheduled

Oxycodone

Drug

Used for both arms PRN

Morphine

Drug

Used for both arms PRN

Gabapentin

Drug

Used for Arm B

Toradol

Drug

Used for Arm B

Bupivacaine

Drug

Used for Arm B - anesthesia block

Primary outcomes

  1. 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.

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

  2. Mean Morphine Equivalents

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

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

Secondary outcomes

  1. Length of Stay

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

    Length of stay in days

  2. Number of Patients With Post-operative Complications

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

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

  3. Patient Pain Percentage Compared to Baseline

    Time frame: 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.

    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

  4. Patient Pain Assessment Percentage

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

    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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Jan 29, 2020
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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