Trial Outcomes & Findings for Efficacy of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy (NCT NCT02112370)
NCT ID: NCT02112370
Last Updated: 2017-08-04
Results Overview
The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location. Range: 0(minimal pain, better outcome) \~ 10(maximum pain, worse outcome) Unlike the general NRS pain score as reported in the "post-operative 48 hour" result which deals with post-operative discomfort in general, this outcome measures the pain score of the specific location in which flap dissection had taken place.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
148 participants
Primary outcome timeframe
Postoperative 12 hours
Results posted on
2017-08-04
Participant Flow
Participant milestones
| Measure |
Normal Saline Injection
100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
|
Ropivacaine With Epinephrine Injection
1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
74
|
|
Overall Study
COMPLETED
|
74
|
74
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Ropivacaine (With Epinephrine) in BABA Endoscopic and Robotic Thyroidectomy
Baseline characteristics by cohort
| Measure |
Normal Saline Injection
n=74 Participants
100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
|
Ropivacaine With Epinephrine Injection
n=74 Participants
1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.0 years
STANDARD_DEVIATION 9.3 • n=93 Participants
|
35.5 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
36.1 years
STANDARD_DEVIATION 9.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
135 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Preoperative thyroid function test (T3, ng/dL)
|
121.8 ng/dL
STANDARD_DEVIATION 15.0 • n=93 Participants
|
123.3 ng/dL
STANDARD_DEVIATION 25.1 • n=4 Participants
|
122.5 ng/dL
STANDARD_DEVIATION 20.6 • n=27 Participants
|
|
Preoperative thyroid function test (free T4, ng/dL)
|
1.2 ng/dL
STANDARD_DEVIATION 0.3 • n=93 Participants
|
1.2 ng/dL
STANDARD_DEVIATION 0.4 • n=4 Participants
|
1.2 ng/dL
STANDARD_DEVIATION 0.4 • n=27 Participants
|
|
Preoperative thyroid function test (TSH, uIU/mL)
|
1.8 uIU/mL
STANDARD_DEVIATION 1.0 • n=93 Participants
|
2.2 uIU/mL
STANDARD_DEVIATION 1.7 • n=4 Participants
|
2.0 uIU/mL
STANDARD_DEVIATION 1.4 • n=27 Participants
|
|
Method of operation (robotic/endoscopic)
Robotic
|
53 participants
n=93 Participants
|
55 participants
n=4 Participants
|
108 participants
n=27 Participants
|
|
Method of operation (robotic/endoscopic)
Endoscopic
|
21 participants
n=93 Participants
|
19 participants
n=4 Participants
|
40 participants
n=27 Participants
|
|
Extent of operation (Right/Left/Total)
Right
|
26 participants
n=93 Participants
|
29 participants
n=4 Participants
|
55 participants
n=27 Participants
|
|
Extent of operation (Right/Left/Total)
Left
|
28 participants
n=93 Participants
|
24 participants
n=4 Participants
|
52 participants
n=27 Participants
|
|
Extent of operation (Right/Left/Total)
Total
|
20 participants
n=93 Participants
|
21 participants
n=4 Participants
|
41 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Postoperative 12 hoursThe numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location. Range: 0(minimal pain, better outcome) \~ 10(maximum pain, worse outcome) Unlike the general NRS pain score as reported in the "post-operative 48 hour" result which deals with post-operative discomfort in general, this outcome measures the pain score of the specific location in which flap dissection had taken place.
Outcome measures
| Measure |
Normal Saline Injection
n=74 Participants
100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
|
Ropivacaine With Epinephrine Injection
n=74 Participants
1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
|
|---|---|---|
|
NRS Pain Scores for the First 12 Hours
Swallowing difficulty
|
4.93 points
Standard Deviation 1.79
|
4.12 points
Standard Deviation 1.87
|
|
NRS Pain Scores for the First 12 Hours
Anterior neck pain
|
4.50 points
Standard Deviation 2.10
|
3.69 points
Standard Deviation 1.94
|
|
NRS Pain Scores for the First 12 Hours
Right chest pain
|
3.99 points
Standard Deviation 2.27
|
3.16 points
Standard Deviation 1.96
|
|
NRS Pain Scores for the First 12 Hours
Left chest pain
|
3.74 points
Standard Deviation 1.94
|
4.51 points
Standard Deviation 2.45
|
|
NRS Pain Scores for the First 12 Hours
Back pain
|
0.65 points
Standard Deviation 1.50
|
0.28 points
Standard Deviation 1.05
|
|
NRS Pain Scores for the First 12 Hours
Posterior neck pain
|
1.47 points
Standard Deviation 2.07
|
1.65 points
Standard Deviation 2.40
|
SECONDARY outcome
Timeframe: participants were followed for the duration of the operation, an average of approximately 2.5 hoursThe maximal systolic blood pressure is monitored during surgery.
Outcome measures
| Measure |
Normal Saline Injection
n=74 Participants
100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
|
Ropivacaine With Epinephrine Injection
n=74 Participants
1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
|
|---|---|---|
|
Maximum of Measured Systolic Blood Pressures
|
142 mmHg
Standard Deviation 16.5
|
145 mmHg
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: participants were followed for the duration of the operation, an average of approximately 2.5 hoursThe maximal diastolic blood pressure is monitored during surgery.
Outcome measures
| Measure |
Normal Saline Injection
n=74 Participants
100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
|
Ropivacaine With Epinephrine Injection
n=74 Participants
1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
|
|---|---|---|
|
Maximum of Measured Diastolic Blood Pressures
|
91 mmHg
Standard Deviation 14.9
|
86 mmHg
Standard Deviation 19.2
|
SECONDARY outcome
Timeframe: participants were followed for the duration of the operation, an average of approximately 2.5 hoursThe maximal heart rate is monitored during surgery.
Outcome measures
| Measure |
Normal Saline Injection
n=74 Participants
100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
|
Ropivacaine With Epinephrine Injection
n=74 Participants
1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
|
|---|---|---|
|
Maximum of Measured Heart Rates
|
88 beats per minute
Standard Deviation 16.1
|
99 beats per minute
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: participants were followed for the duration of the operation, an average of approximately 2.5 hoursThe blood loss amount is estimated at the end of surgery.
Outcome measures
| Measure |
Normal Saline Injection
n=74 Participants
100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
|
Ropivacaine With Epinephrine Injection
n=74 Participants
1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
|
|---|---|---|
|
Blood Loss Amount
|
30 ml
Standard Deviation 58.2
|
18 ml
Standard Deviation 40.5
|
SECONDARY outcome
Timeframe: participants were followed for the duration of the operation, an average of approximately 2.5 hoursThe amount of time taken from start to the end of surgery
Outcome measures
| Measure |
Normal Saline Injection
n=74 Participants
100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
|
Ropivacaine With Epinephrine Injection
n=74 Participants
1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
|
|---|---|---|
|
Operation Time
|
163.6 minutes
Standard Deviation 54.1
|
155.3 minutes
Standard Deviation 46.8
|
SECONDARY outcome
Timeframe: 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operationChange in NRS score a with time The numerical rating scale is utilized to assess the postoperative pain change for the first 12 hours according to location. Range: 0(minimal pain, better outcome) \~ 10(maximum pain, worse outcome)
Outcome measures
| Measure |
Normal Saline Injection
n=74 Participants
100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
|
Ropivacaine With Epinephrine Injection
n=74 Participants
1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
|
|---|---|---|
|
NRS Change
9 hour
|
3.28 scores on a scale
Standard Deviation 1.34
|
3.14 scores on a scale
Standard Deviation 1.38
|
|
NRS Change
0 hour
|
5.73 scores on a scale
Standard Deviation 2.02
|
5.68 scores on a scale
Standard Deviation 2.13
|
|
NRS Change
1 hour
|
5.05 scores on a scale
Standard Deviation 1.95
|
4.7 scores on a scale
Standard Deviation 1.59
|
|
NRS Change
2 hour
|
4.55 scores on a scale
Standard Deviation 1.80
|
4.11 scores on a scale
Standard Deviation 1.56
|
|
NRS Change
4 hour
|
3.55 scores on a scale
Standard Deviation 1.27
|
3.34 scores on a scale
Standard Deviation 1.19
|
|
NRS Change
6 hour
|
3.39 scores on a scale
Standard Deviation 1.29
|
3.28 scores on a scale
Standard Deviation 1.22
|
|
NRS Change
12 hour
|
3.19 scores on a scale
Standard Deviation 1.37
|
3.18 scores on a scale
Standard Deviation 1.23
|
|
NRS Change
24 hour
|
2.93 scores on a scale
Standard Deviation 1.09
|
2.95 scores on a scale
Standard Deviation 1.05
|
|
NRS Change
48 hour
|
2.27 scores on a scale
Standard Deviation 0.94
|
2.08 scores on a scale
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: 0, 1, 2, 4, 6, 9, 12, 24, and 48 hours post operationChange in pain killer usage with time
Outcome measures
| Measure |
Normal Saline Injection
n=74 Participants
100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
Placebo: 100cc normal saline is injected into the subcutaneous layer for the initial flap dissection.
|
Ropivacaine With Epinephrine Injection
n=74 Participants
1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
Ropivacaine with epinephrine injection: 1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection.
|
|---|---|---|
|
Pain Killer Dose
0 hour
|
1 vials (15mg ketorolac per vial)
Standard Deviation 0.72
|
0.84 vials (15mg ketorolac per vial)
Standard Deviation 0.60
|
|
Pain Killer Dose
1 hour
|
0.35 vials (15mg ketorolac per vial)
Standard Deviation 0.51
|
0.31 vials (15mg ketorolac per vial)
Standard Deviation 0.47
|
|
Pain Killer Dose
2 hour
|
0.31 vials (15mg ketorolac per vial)
Standard Deviation 0.49
|
0.26 vials (15mg ketorolac per vial)
Standard Deviation 0.44
|
|
Pain Killer Dose
4 hour
|
0.07 vials (15mg ketorolac per vial)
Standard Deviation 0.25
|
0.11 vials (15mg ketorolac per vial)
Standard Deviation 0.31
|
|
Pain Killer Dose
6 hour
|
0.18 vials (15mg ketorolac per vial)
Standard Deviation 0.38
|
0.15 vials (15mg ketorolac per vial)
Standard Deviation 0.36
|
|
Pain Killer Dose
9 hour
|
0.14 vials (15mg ketorolac per vial)
Standard Deviation 0.34
|
0.12 vials (15mg ketorolac per vial)
Standard Deviation 0.33
|
|
Pain Killer Dose
12 hour
|
0.18 vials (15mg ketorolac per vial)
Standard Deviation 0.42
|
0.19 vials (15mg ketorolac per vial)
Standard Deviation 0.43
|
|
Pain Killer Dose
24 hour
|
0.20 vials (15mg ketorolac per vial)
Standard Deviation 0.44
|
0.16 vials (15mg ketorolac per vial)
Standard Deviation 0.41
|
|
Pain Killer Dose
48 hour
|
0.01 vials (15mg ketorolac per vial)
Standard Deviation 0.11
|
0.07 vials (15mg ketorolac per vial)
Standard Deviation 0.15
|
Adverse Events
Normal Saline Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ropivacaine With Epinephrine Injection
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
Dr. Kyu Eun Lee
Seoul National University Hospital Department of Surgery
Phone: +82)-2-2072-2817
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place