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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| Standard of Care B | Experimental | Arm B, will include:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tylenol | Drug | Used for both arms, scheduled |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Length of stay in days | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Shnayder, MD | KUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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prospective
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
Tylenol: Used for both arms, scheduled Oxycodone: Used for both arms PRN Morphine: Used for both arms PRN |
| FG001 | Standard of Care B | Arm B, will include:
Tylenol: Used for both arms, scheduled Oxycodone: Used for both arms PRN Morphine: Used for both arms PRN Gabapentin: Used for Arm B toradol: Used for Arm B Bupivacaine: Used for Arm B - anesthesia block |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Caucasian
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
Tylenol: Used for both arms, scheduled Oxycodone: Used for both arms PRN Morphine: Used for both arms PRN |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Morphine Equivalents During Stay | Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them. | Posted | Mean | Standard Deviation | Morphine Milligram Equivalents (MME) | Duration of their initial post-operative hospital stay as defined as the interval between index surgery to post-operative day 7. |
|
1 year
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
Tylenol: Used for both arms, scheduled Oxycodone: Used for both arms PRN Morphine: Used for both arms PRN |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yelizaveta Shnayder | University of Kansas medical Center | 913-588-6701 | yshnayder@kumc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 26, 2019 | Apr 2, 2025 | Prot_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 21, 2019 | Apr 2, 2025 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D010098 | Oxycodone |
| D009020 | Morphine |
| D000077206 | Gabapentin |
| D020911 | Ketorolac Tromethamine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Oxycodone |
| Drug |
Used for both arms PRN |
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| Morphine | Drug | Used for both arms PRN |
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| Gabapentin | Drug | Used for Arm B |
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| toradol | Drug | Used for Arm B |
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| Bupivacaine | Drug | Used for Arm B - anesthesia block |
|
Monitor chart/EMR for bleeding, acute kidney injury, etc.
| Analyze the first 7 post-operative days to confirm number of patients with post-operative complications |
| 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":
| 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 | 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. | Daily. The ABC pain scale will be given once daily for the patient to fill out for the first seven days. |
| BG001 | Standard of Care B | Arm B, will include:
Tylenol: Used for both arms, scheduled Oxycodone: Used for both arms PRN Morphine: Used for both arms PRN Gabapentin: Used for Arm B toradol: Used for Arm B Bupivacaine: Used for Arm B - anesthesia block |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Standard of Care B | Arm B, will include:
Tylenol: Used for both arms, scheduled Oxycodone: Used for both arms PRN Morphine: Used for both arms PRN Gabapentin: Used for Arm B toradol: Used for Arm B Bupivacaine: Used for Arm B - anesthesia block |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Morphine Milligram Equivalents (MME) | From day of index surgery to 1 year post-operatively. |
|
|
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| Secondary | Length of Stay | Length of stay in days | Posted | Median | Inter-Quartile Range | days | At end of stay, number of post-operative days spent in the hospital was recorded for each patient. |
|
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| Secondary | Number of Patients With Post-operative Complications | Monitor chart/EMR for bleeding, acute kidney injury, etc. | Posted | Count of Participants | Participants | Analyze the first 7 post-operative days to confirm number of patients with post-operative complications |
|
|
|
| Secondary | 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":
| Posted | Mean | Standard Deviation | percentage change from 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. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | ABC pain assessment percentage | Daily. The ABC pain scale will be given once daily for the patient to fill out for the first seven days. |
|
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Standard of Care B | Arm B, will include:
Tylenol: Used for both arms, scheduled Oxycodone: Used for both arms PRN Morphine: Used for both arms PRN Gabapentin: Used for Arm B toradol: Used for Arm B Bupivacaine: Used for Arm B - anesthesia block | 0 | 16 | 0 | 16 | 0 | 16 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| POD6 |
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| POD7 |
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| POD2 |
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| POD3 |
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| POD4 |
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| POD5 |
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| POD6 |
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| POD7 |
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