Trial Outcomes & Findings for Multimodal Pain Study in Free Flap Patients (NCT NCT04246697)
NCT ID: NCT04246697
Last Updated: 2026-07-07
Results Overview
Mean morphine equivalents will be calculated after converting all opioids to morphine equivalents and then averaging them.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
Duration of their initial post-operative hospital stay as defined as the interval between index surgery to post-operative day 7.
Results posted on
2026-07-07
Participant Flow
prospective
Participant milestones
| Measure |
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.
Tylenol: Used for both arms, scheduled
Oxycodone: Used for both arms PRN
Morphine: Used for both arms PRN
|
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
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
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
|
Overall Study
COMPLETED
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multimodal Pain Study in Free Flap Patients
Baseline characteristics by cohort
| Measure |
Standard of Care A
n=14 Participants
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.
Tylenol: Used for both arms, scheduled
Oxycodone: Used for both arms PRN
Morphine: Used for both arms PRN
|
Standard of Care B
n=16 Participants
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
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
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
|
Age, Continuous
|
69.4 years
STANDARD_DEVIATION 12.2 • n=20 Participants
|
62.9 years
STANDARD_DEVIATION 13.8 • n=20 Participants
|
65.9 years
STANDARD_DEVIATION 13.3 • n=40 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
28 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=20 Participants
|
16 participants
n=20 Participants
|
30 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard of Care A
n=14 Participants
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.
Tylenol: Used for both arms, scheduled
Oxycodone: Used for both arms PRN
Morphine: Used for both arms PRN
|
Standard of Care B
n=16 Participants
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
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
|
|---|---|---|
|
Mean Morphine Equivalents During Stay
|
222.8 Morphine Milligram Equivalents (MME)
Standard Deviation 121.4
|
101.9 Morphine Milligram Equivalents (MME)
Standard Deviation 100.0
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard of Care A
n=14 Participants
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.
Tylenol: Used for both arms, scheduled
Oxycodone: Used for both arms PRN
Morphine: Used for both arms PRN
|
Standard of Care B
n=16 Participants
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
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
|
|---|---|---|
|
Mean Morphine Equivalents
|
251.60 Morphine Milligram Equivalents (MME)
Standard Deviation 224.57
|
195.78 Morphine Milligram Equivalents (MME)
Standard Deviation 131.08
|
SECONDARY outcome
Timeframe: At end of stay, number of post-operative days spent in the hospital was recorded for each patient.Length of stay in days
Outcome measures
| Measure |
Standard of Care A
n=14 Participants
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.
Tylenol: Used for both arms, scheduled
Oxycodone: Used for both arms PRN
Morphine: Used for both arms PRN
|
Standard of Care B
n=16 Participants
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
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
|
|---|---|---|
|
Length of Stay
|
8 days
Interval 7.0 to 10.0
|
7 days
Interval 7.0 to 8.0
|
SECONDARY outcome
Timeframe: Analyze the first 7 post-operative days to confirm number of patients with post-operative complicationsMonitor chart/EMR for bleeding, acute kidney injury, etc.
Outcome measures
| Measure |
Standard of Care A
n=14 Participants
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.
Tylenol: Used for both arms, scheduled
Oxycodone: Used for both arms PRN
Morphine: Used for both arms PRN
|
Standard of Care B
n=16 Participants
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
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
|
|---|---|---|
|
Number of Patients With Post-operative Complications
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Standard of Care A
n=14 Participants
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.
Tylenol: Used for both arms, scheduled
Oxycodone: Used for both arms PRN
Morphine: Used for both arms PRN
|
Standard of Care B
n=16 Participants
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
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
|
|---|---|---|
|
Patient Pain Percentage Compared to Baseline
POD1
|
89.1 percentage change from baseline
Standard Deviation 6.6
|
23.3 percentage change from baseline
Standard Deviation 13.0
|
|
Patient Pain Percentage Compared to Baseline
POD2
|
44.8 percentage change from baseline
Standard Deviation 1.4
|
25.0 percentage change from baseline
Standard Deviation 2.3
|
|
Patient Pain Percentage Compared to Baseline
POD3
|
62.4 percentage change from baseline
Standard Deviation 18.6
|
35.4 percentage change from baseline
Standard Deviation 21.4
|
|
Patient Pain Percentage Compared to Baseline
POD4
|
44.8 percentage change from baseline
Standard Deviation 23.4
|
52.0 percentage change from baseline
Standard Deviation 59.6
|
|
Patient Pain Percentage Compared to Baseline
POD5
|
25.7 percentage change from baseline
Standard Deviation 34.6
|
28.0 percentage change from baseline
Standard Deviation 18.1
|
|
Patient Pain Percentage Compared to Baseline
POD6
|
10.9 percentage change from baseline
Standard Deviation 36.5
|
23.6 percentage change from baseline
Standard Deviation 30.8
|
|
Patient Pain Percentage Compared to Baseline
POD7
|
39.5 percentage change from baseline
Standard Deviation 18.1
|
12.0 percentage change from baseline
Standard Deviation 23.4
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard of Care A
n=14 Participants
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.
Tylenol: Used for both arms, scheduled
Oxycodone: Used for both arms PRN
Morphine: Used for both arms PRN
|
Standard of Care B
n=16 Participants
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
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
|
|---|---|---|
|
Patient Pain Assessment Percentage
Baseline
|
22.64 ABC pain assessment percentage
Standard Deviation 10.10
|
22.77 ABC pain assessment percentage
Standard Deviation 6.87
|
|
Patient Pain Assessment Percentage
POD1
|
44.55 ABC pain assessment percentage
Standard Deviation 18.98
|
37.51 ABC pain assessment percentage
Standard Deviation 17.52
|
|
Patient Pain Assessment Percentage
POD2
|
33.16 ABC pain assessment percentage
Standard Deviation 16.43
|
31.72 ABC pain assessment percentage
Standard Deviation 16.46
|
|
Patient Pain Assessment Percentage
POD3
|
26.77 ABC pain assessment percentage
Standard Deviation 19.29
|
32.29 ABC pain assessment percentage
Standard Deviation 14.81
|
|
Patient Pain Assessment Percentage
POD4
|
22.01 ABC pain assessment percentage
Standard Deviation 6.21
|
26.99 ABC pain assessment percentage
Standard Deviation 16.37
|
|
Patient Pain Assessment Percentage
POD5
|
23.08 ABC pain assessment percentage
Standard Deviation 6.47
|
27.88 ABC pain assessment percentage
Standard Deviation 12.95
|
|
Patient Pain Assessment Percentage
POD6
|
28.10 ABC pain assessment percentage
Standard Deviation 10.01
|
28.28 ABC pain assessment percentage
Standard Deviation 12.05
|
|
Patient Pain Assessment Percentage
POD7
|
25.83 ABC pain assessment percentage
Standard Deviation 6.96
|
26.48 ABC pain assessment percentage
Standard Deviation 11.36
|
Adverse Events
Standard of Care A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Yelizaveta Shnayder
University of Kansas medical Center
Phone: 913-588-6701
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place