Trial Outcomes & Findings for Local Infusion of Ropivacaine for Post-Op Pain Control After Osseocutaneous Free Flaps (NCT NCT03349034)
NCT ID: NCT03349034
Last Updated: 2020-11-17
Results Overview
Pain assessed every 8 hours for the first 48 hours using a visual analogue pain scale at rest. A visual analogue pain scale is a validated pain measure. Essentially, there is a 100 millimeter line drawn on a piece of paper, with "no pain" marking the left end of the line and "worst pain" marking the right end of the line. Subjects mark with a pen along the line where pain is felt fits along that continuum. A researcher then measures how far along the line that mark is placed and then it is recorded. Full scale from 0-100, higher score indicates more pain.
COMPLETED
PHASE2
24 participants
8, 16, 24, 32, 40 and 48 hours
2020-11-17
Participant Flow
Participants undergoing osseocutaneous fibula or scapular tip free flaps for head and neck reconstructionwere enrolled from September 2017 and September 2019.
Participant milestones
| Measure |
Saline Placebo
Local Saline Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
|
Ropivacaine
Local Ropivicaine Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Saline Placebo
Local Saline Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
|
Ropivacaine
Local Ropivicaine Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
|
|---|---|---|
|
Overall Study
catheters dislodged during transport
|
2
|
0
|
|
Overall Study
intubated for >48 hrs following surgery
|
1
|
1
|
|
Overall Study
soft tissue flap used
|
1
|
0
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Saline Placebo
n=8 Participants
Local Saline Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
|
Ropivacaine
n=10 Participants
Local Ropivicaine Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.1 years
STANDARD_DEVIATION 11.6 • n=8 Participants
|
67.1 years
STANDARD_DEVIATION 13.7 • n=10 Participants
|
66.2 years
STANDARD_DEVIATION 12.6 • n=18 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=8 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=8 Participants
|
8 Participants
n=10 Participants
|
16 Participants
n=18 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index
|
27.2 kg/m^2
STANDARD_DEVIATION 4.81 • n=8 Participants
|
28.7 kg/m^2
STANDARD_DEVIATION 4.39 • n=10 Participants
|
28.0 kg/m^2
STANDARD_DEVIATION 4.51 • n=18 Participants
|
|
ASA Physical Status Classification System
|
2.88 units on a scale
STANDARD_DEVIATION 0.35 • n=8 Participants
|
3.10 units on a scale
STANDARD_DEVIATION 0.32 • n=10 Participants
|
3.0 units on a scale
STANDARD_DEVIATION 0.34 • n=18 Participants
|
|
Pack Years
|
7.75 cigarettes per day for 1 year
STANDARD_DEVIATION 15.1 • n=8 Participants
|
7.30 cigarettes per day for 1 year
STANDARD_DEVIATION 10.1 • n=10 Participants
|
7.5 cigarettes per day for 1 year
STANDARD_DEVIATION 12.2 • n=18 Participants
|
|
Smoking at Diagnosis
|
0 Participants
n=8 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=18 Participants
|
|
Number of participants with Alcohol Abuse
|
1 Participants
n=8 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=18 Participants
|
|
Number of participants with Diabetes Mellitus
|
3 Participants
n=8 Participants
|
4 Participants
n=10 Participants
|
7 Participants
n=18 Participants
|
|
Tumor Type
squamous cell carcinoma (SCC)
|
4 Participants
n=8 Participants
|
6 Participants
n=10 Participants
|
10 Participants
n=18 Participants
|
|
Tumor Type
Benign
|
4 Participants
n=8 Participants
|
4 Participants
n=10 Participants
|
8 Participants
n=18 Participants
|
|
Primary Site/Procedure
Maxilla/Maxillectomy
|
5 Participants
n=8 Participants
|
2 Participants
n=10 Participants
|
7 Participants
n=18 Participants
|
|
Primary Site/Procedure
Mandible/Mandibulectomy
|
3 Participants
n=8 Participants
|
8 Participants
n=10 Participants
|
11 Participants
n=18 Participants
|
|
Flap Type
Scapula
|
4 Participants
n=8 Participants
|
6 Participants
n=10 Participants
|
10 Participants
n=18 Participants
|
|
Flap Type
Fibula
|
4 Participants
n=8 Participants
|
4 Participants
n=10 Participants
|
8 Participants
n=18 Participants
|
|
Previous Treatment
History of Radiation Therapy
|
1 Participants
n=8 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=18 Participants
|
|
Previous Treatment
History of Chemotherapy
|
1 Participants
n=8 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=18 Participants
|
|
Length of Stay
|
11.5 days
STANDARD_DEVIATION 3.89 • n=8 Participants
|
13.8 days
STANDARD_DEVIATION 6.34 • n=10 Participants
|
12.8 days
STANDARD_DEVIATION 5.37 • n=18 Participants
|
PRIMARY outcome
Timeframe: 8, 16, 24, 32, 40 and 48 hoursPain assessed every 8 hours for the first 48 hours using a visual analogue pain scale at rest. A visual analogue pain scale is a validated pain measure. Essentially, there is a 100 millimeter line drawn on a piece of paper, with "no pain" marking the left end of the line and "worst pain" marking the right end of the line. Subjects mark with a pen along the line where pain is felt fits along that continuum. A researcher then measures how far along the line that mark is placed and then it is recorded. Full scale from 0-100, higher score indicates more pain.
Outcome measures
| Measure |
Saline Placebo
n=8 Participants
Local Saline Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
|
Ropivacaine
n=10 Participants
Local Ropivicaine Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
|
|---|---|---|
|
Post-Operative Pain at Donor-Site
24 hour
|
23.33 score on a scale
Standard Deviation 29.28
|
45.67 score on a scale
Standard Deviation 24.87
|
|
Post-Operative Pain at Donor-Site
32 hour
|
25.67 score on a scale
Standard Deviation 27.28
|
37.44 score on a scale
Standard Deviation 31.11
|
|
Post-Operative Pain at Donor-Site
40 hour
|
30.12 score on a scale
Standard Deviation 22.29
|
42.11 score on a scale
Standard Deviation 30.64
|
|
Post-Operative Pain at Donor-Site
8 hour
|
52.40 score on a scale
Standard Deviation 25.33
|
41.14 score on a scale
Standard Deviation 28.30
|
|
Post-Operative Pain at Donor-Site
16 hour
|
41.00 score on a scale
Standard Deviation 33.20
|
40.88 score on a scale
Standard Deviation 31.46
|
|
Post-Operative Pain at Donor-Site
48 hour
|
28.75 score on a scale
Standard Deviation 21.72
|
30.60 score on a scale
Standard Deviation 28.30
|
PRIMARY outcome
Timeframe: 8, 16, 24, 32, 40 and 48 hoursPain assessed every 8 hours for the first 48 hours using a visual analogue pain scale at rest. A visual analogue pain scale is a validated pain measure. Essentially, there is a 100 millimeter line drawn on a piece of paper, with "no pain" marking the left end of the line and "worst pain" marking the right end of the line. Subjects mark with a pen along the line where pain is felt fits along that continuum. A researcher then measures how far along the line that mark is placed and then it is recorded. Full scale from 0-100, higher score indicates more pain.
Outcome measures
| Measure |
Saline Placebo
n=8 Participants
Local Saline Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
|
Ropivacaine
n=10 Participants
Local Ropivicaine Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
|
|---|---|---|
|
Post-Operative Pain - Global Pain
40 hour
|
21.88 score on a scale
Standard Deviation 20.36
|
33.60 score on a scale
Standard Deviation 28.76
|
|
Post-Operative Pain - Global Pain
48 hour
|
20.38 score on a scale
Standard Deviation 13.43
|
37.40 score on a scale
Standard Deviation 35.50
|
|
Post-Operative Pain - Global Pain
8 hour
|
44.00 score on a scale
Standard Deviation 28.55
|
40.14 score on a scale
Standard Deviation 32.25
|
|
Post-Operative Pain - Global Pain
16 hour
|
27.50 score on a scale
Standard Deviation 23.18
|
26.56 score on a scale
Standard Deviation 27.03
|
|
Post-Operative Pain - Global Pain
24 hour
|
31.83 score on a scale
Standard Deviation 21.25
|
41.56 score on a scale
Standard Deviation 30.33
|
|
Post-Operative Pain - Global Pain
32 hour
|
24.17 score on a scale
Standard Deviation 25.91
|
35.67 score on a scale
Standard Deviation 32.39
|
SECONDARY outcome
Timeframe: 48 hoursAll subjects receive standing tylenol 650mg every 6 hours as well as a dilaudid PCA set for low-dose, opioid-naive patients for the first 48 hours post-operatively. Total opioid consumption for each subject during the first 48 hours is recorded measured in oral morphine equivalents (OME).
Outcome measures
| Measure |
Saline Placebo
n=8 Participants
Local Saline Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
|
Ropivacaine
n=10 Participants
Local Ropivicaine Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
|
|---|---|---|
|
Opioid Consumption
|
119.75 OME
Standard Deviation 145.92
|
91.20 OME
Standard Deviation 132.14
|
SECONDARY outcome
Timeframe: 48 hoursPopulation: Data not collected
At 48 hours all subjects will receive a physical therapy evaluation. Range of motion will be measured in degrees
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 hoursAt 48 hours all subjects received a physical therapy evaluation. Distance ambulated measured in feet.
Outcome measures
| Measure |
Saline Placebo
n=8 Participants
Local Saline Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
|
Ropivacaine
n=10 Participants
Local Ropivicaine Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
|
|---|---|---|
|
Distance Ambulated
|
152 feet
Standard Deviation 111.9
|
80 feet
Standard Deviation 67.08
|
SECONDARY outcome
Timeframe: 48 hoursAt 48 hours all subjects received a physical therapy evaluation. Strength measured on a standard neurological 5 point scale: 0 = Complete Paralysis to 5 = Normal Power.
Outcome measures
| Measure |
Saline Placebo
n=8 Participants
Local Saline Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
|
Ropivacaine
n=10 Participants
Local Ropivicaine Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
|
|---|---|---|
|
Strength
|
2.67 score on a scale
Standard Deviation 0.82
|
2.20 score on a scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: 48 hoursPain question on APS-POQ-R - A standardized pain satisfaction survey distributed to subjects at 48 hours rating their overall satisfaction with postoperative pain management. a 16-item questions measured on a 10-point numeric likert scale, with higher scores indicating more pain. Total range from 0 (no pain) to 200 (severe pain).
Outcome measures
| Measure |
Saline Placebo
n=8 Participants
Local Saline Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
|
Ropivacaine
n=10 Participants
Local Ropivicaine Infusion: Patients randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
|
|---|---|---|
|
American Pain Society-Patient Outcome Questionnaire - (APS-POQ-R)
|
6.0 score on a scale
Standard Deviation 2.39
|
4.3 score on a scale
Standard Deviation 1.34
|
Adverse Events
Saline Placebo
Ropivacaine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Brett Miles
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60