Trial Outcomes & Findings for Thoracic Paravertebral Block Using Ropivacaine and Dexmedetomidine (NCT NCT02814890)
NCT ID: NCT02814890
Last Updated: 2020-08-06
Results Overview
Pain Numerical Rating Scales （NRS) at rest（0: no pain--means the minimum value; 10: worst possible pain--means the maximum value)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
assessed over 48 hours after surgery, self reported pain intensity at 2 days reported
Results posted on
2020-08-06
Participant Flow
Sixty-five patients were initially recruited in Auguest, 2016.
The participants who were converted to thoracotomy because of intraoperative bleeding or pleural adhesions would be wash out.
Participant milestones
| Measure |
Group RD(Ropivacaine and Dexmedetomidine)
Thoracic paravertebral block is performed using 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine at the end of video-assisted pneumonectomy.
Video-assisted Pneumonectomy: Video-assisted Pneumonectomy under general anesthesia.
Thoracic paravertebral block: The procedure is guided by ultrasound combined with nerve stimulator at T4-5, T5-6, T6-7, T7-8 of surgical side.
Sixty-five patients were initially recruited. Five patients were excluded from present study, including 3 patients in group RD who were converted to thoracotomy because of intraoperative bleeding or pleural adhesions.
|
Group R(Ropivacaine Only)
Thoracic paravertebral block is performed using 75mg/20ml ropivacaine at the end of video-assisted pneumonectomy.
Video-assisted Pneumonectomy: Video-assisted Pneumonectomy under general anesthesia.
Thoracic paravertebral block: The procedure is guided by ultrasound combined with nerve stimulator at T4-5, T5-6, T6-7, T7-8 of surgical side.
Sixty-five patients were initially recruited. Five patients were excluded from present study, including 2 patients in group R who were converted to thoracotomy because of intraoperative bleeding or pleural adhesions.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
32
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Measure Analysis Population Description: 5 patients were excluded due to their type of surgery transfering from VATS to thoracotomy, in which 3 patients in Group RD and 2 ones in Group R.
Baseline characteristics by cohort
| Measure |
Group RD(Ropivacaine and Dexmedetomidine)
n=33 Participants
Thoracic paravertebral block is performed using 75mg/20ml ropivacaine + 1μg/kg dexmedetomidine at the end of video-assisted pneumonectomy.
Video-assisted Pneumonectomy: Video-assisted Pneumonectomy under general anesthesia.
Thoracic paravertebral block: The procedure is guided by ultrasound combined with nerve stimulator at T4-5, T5-6, T6-7, T7-8 of surgical side.
There were no significant differences between two groups in demographic and operative data(Gender, Age, Weight, Height, ASA（Ⅰ/Ⅱ), FEV1 (% predicted), FEV1/FVC (% predicted), Intraoperative fentanyl, Duration of surgery, Duration of anesthesia).
|
Group R(Ropivacaine Only)
n=32 Participants
Thoracic paravertebral block is performed using 75mg/20ml ropivacaine at the end of video-assisted pneumonectomy.
Video-assisted Pneumonectomy: Video-assisted Pneumonectomy under general anesthesia.
Thoracic paravertebral block: The procedure is guided by ultrasound combined with nerve stimulator at T4-5, T5-6, T6-7, T7-8 of surgical side.
There were no significant differences between two groups in demographic and operative data(Gender, Age, Weight, Height, ASA（Ⅰ/Ⅱ), FEV1 (% predicted), FEV1/FVC (% predicted), Intraoperative fentanyl, Duration of surgery, Duration of anesthesia).
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
recruited number of participants
|
59.2 years
STANDARD_DEVIATION 9.6 • n=33 Participants • Measure Analysis Population Description: 5 patients were excluded due to their type of surgery transfering from VATS to thoracotomy, in which 3 patients in Group RD and 2 ones in Group R.
|
59.7 years
STANDARD_DEVIATION 9.4 • n=32 Participants • Measure Analysis Population Description: 5 patients were excluded due to their type of surgery transfering from VATS to thoracotomy, in which 3 patients in Group RD and 2 ones in Group R.
|
59.6 years
STANDARD_DEVIATION 9.3 • n=65 Participants • Measure Analysis Population Description: 5 patients were excluded due to their type of surgery transfering from VATS to thoracotomy, in which 3 patients in Group RD and 2 ones in Group R.
|
|
Age, Continuous
analyzed number of participants
|
59.2 years
STANDARD_DEVIATION 9.7 • n=30 Participants • Measure Analysis Population Description: 5 patients were excluded due to their type of surgery transfering from VATS to thoracotomy, in which 3 patients in Group RD and 2 ones in Group R.
|
59.5 years
STANDARD_DEVIATION 9.7 • n=30 Participants • Measure Analysis Population Description: 5 patients were excluded due to their type of surgery transfering from VATS to thoracotomy, in which 3 patients in Group RD and 2 ones in Group R.
|
59.3 years
STANDARD_DEVIATION 9.6 • n=60 Participants • Measure Analysis Population Description: 5 patients were excluded due to their type of surgery transfering from VATS to thoracotomy, in which 3 patients in Group RD and 2 ones in Group R.
|
|
Sex: Female, Male
Female
|
12 Participants
n=30 Participants • 5 patients were excluded due to their type of surgery transfering from VATS to thoracotomy, in which 3 patients in Group RD and 2 ones in Group R.
|
13 Participants
n=30 Participants • 5 patients were excluded due to their type of surgery transfering from VATS to thoracotomy, in which 3 patients in Group RD and 2 ones in Group R.
|
25 Participants
n=60 Participants • 5 patients were excluded due to their type of surgery transfering from VATS to thoracotomy, in which 3 patients in Group RD and 2 ones in Group R.
|
|
Sex: Female, Male
Male
|
18 Participants
n=30 Participants • 5 patients were excluded due to their type of surgery transfering from VATS to thoracotomy, in which 3 patients in Group RD and 2 ones in Group R.
|
17 Participants
n=30 Participants • 5 patients were excluded due to their type of surgery transfering from VATS to thoracotomy, in which 3 patients in Group RD and 2 ones in Group R.
|
35 Participants
n=60 Participants • 5 patients were excluded due to their type of surgery transfering from VATS to thoracotomy, in which 3 patients in Group RD and 2 ones in Group R.
|
PRIMARY outcome
Timeframe: assessed over 48 hours after surgery, self reported pain intensity at 2 days reportedPain Numerical Rating Scales （NRS) at rest（0: no pain--means the minimum value; 10: worst possible pain--means the maximum value)
Outcome measures
| Measure |
Group RD(Ropivacaine and Dexmedetomidine)
n=30 Participants
The pain scores (numerical rating scale, NRS) postoperative 48h at rest and coughing were assessed.
|
Group R(Ropivacaine Only)
n=30 Participants
The pain scores (numerical rating scale, NRS) postoperative 48h at rest and coughing were assessed.
|
|---|---|---|
|
Postoperative Pain (Pain Scores) Intensity Measure
|
1 units on a scale
Interval 0.0 to 2.0
|
3 units on a scale
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: Hour 48 after surgeryusing a 5-point Likert scale (5-point: completely satisfied, 4-point: quite satisfied, 3-point: slightly dissatisfied, 2-point: dissatisfied, 1-point: very dissatisfied)
Outcome measures
| Measure |
Group RD(Ropivacaine and Dexmedetomidine)
n=30 Participants
The pain scores (numerical rating scale, NRS) postoperative 48h at rest and coughing were assessed.
|
Group R(Ropivacaine Only)
n=30 Participants
The pain scores (numerical rating scale, NRS) postoperative 48h at rest and coughing were assessed.
|
|---|---|---|
|
Patient Satisfaction
1 point of 5- point Likert scale
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction
2 point of 5- point Likert scale
|
0 Participants
|
0 Participants
|
|
Patient Satisfaction
3 point of 5- point Likert scale
|
1 Participants
|
7 Participants
|
|
Patient Satisfaction
4 point of 5- point Likert scale
|
9 Participants
|
17 Participants
|
|
Patient Satisfaction
5 point of 5- point Likert scale
|
20 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Hour 24, Hour 48 after surgerya rescue analgesic morphine 5mg will be administered for any pain score ≥4 （0: no pain--means the minimum value; 10: worst possible pain--means the maximum value)
Outcome measures
| Measure |
Group RD(Ropivacaine and Dexmedetomidine)
n=30 Participants
The pain scores (numerical rating scale, NRS) postoperative 48h at rest and coughing were assessed.
|
Group R(Ropivacaine Only)
n=30 Participants
The pain scores (numerical rating scale, NRS) postoperative 48h at rest and coughing were assessed.
|
|---|---|---|
|
Number of Participants With Postoperative Rescue Analgesic Administration
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Hour 48 after surgeryincluding nausea, vomiting, hypotension, bradycardia, and respiratory depression
Outcome measures
| Measure |
Group RD(Ropivacaine and Dexmedetomidine)
n=30 Participants
The pain scores (numerical rating scale, NRS) postoperative 48h at rest and coughing were assessed.
|
Group R(Ropivacaine Only)
n=30 Participants
The pain scores (numerical rating scale, NRS) postoperative 48h at rest and coughing were assessed.
|
|---|---|---|
|
Adverse Events
|
5 Participants
|
3 Participants
|
Adverse Events
Group RD(Ropivacaine and Dexmedetomidine)
Serious events: 3 serious events
Other events: 2 other events
Deaths: 0 deaths
Group R(Ropivacaine Only)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group RD(Ropivacaine and Dexmedetomidine)
n=30 participants at risk
Postoperative adverse effects such as nausea, vomiting, hypotension, hypoxemia, cardiac arrhythmia and the complications from the drugs and technique (local anesthetic toxicity, vascular puncture) were recorded and treated.
|
Group R(Ropivacaine Only)
n=30 participants at risk
Postoperative adverse effects such as nausea, vomiting, hypotension, hypoxemia, cardiac arrhythmia and the complications from the drugs and technique (local anesthetic toxicity, vascular puncture) were recorded and treated.
|
|---|---|---|
|
Cardiac disorders
bradycardia
|
6.7%
2/30 • Number of events 2 • Postoperative 48h adverse effects such as nausea, vomiting, hypotension, hypoxemia, cardiac arrhythmia and the complications from the drugs and technique (local anesthetic toxicity, vascular puncture) were recorded and treated.
|
0.00%
0/30 • Postoperative 48h adverse effects such as nausea, vomiting, hypotension, hypoxemia, cardiac arrhythmia and the complications from the drugs and technique (local anesthetic toxicity, vascular puncture) were recorded and treated.
|
|
Cardiac disorders
Hypotension
|
3.3%
1/30 • Number of events 1 • Postoperative 48h adverse effects such as nausea, vomiting, hypotension, hypoxemia, cardiac arrhythmia and the complications from the drugs and technique (local anesthetic toxicity, vascular puncture) were recorded and treated.
|
0.00%
0/30 • Postoperative 48h adverse effects such as nausea, vomiting, hypotension, hypoxemia, cardiac arrhythmia and the complications from the drugs and technique (local anesthetic toxicity, vascular puncture) were recorded and treated.
|
Other adverse events
| Measure |
Group RD(Ropivacaine and Dexmedetomidine)
n=30 participants at risk
Postoperative adverse effects such as nausea, vomiting, hypotension, hypoxemia, cardiac arrhythmia and the complications from the drugs and technique (local anesthetic toxicity, vascular puncture) were recorded and treated.
|
Group R(Ropivacaine Only)
n=30 participants at risk
Postoperative adverse effects such as nausea, vomiting, hypotension, hypoxemia, cardiac arrhythmia and the complications from the drugs and technique (local anesthetic toxicity, vascular puncture) were recorded and treated.
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
3.3%
1/30 • Number of events 1 • Postoperative 48h adverse effects such as nausea, vomiting, hypotension, hypoxemia, cardiac arrhythmia and the complications from the drugs and technique (local anesthetic toxicity, vascular puncture) were recorded and treated.
|
3.3%
1/30 • Number of events 1 • Postoperative 48h adverse effects such as nausea, vomiting, hypotension, hypoxemia, cardiac arrhythmia and the complications from the drugs and technique (local anesthetic toxicity, vascular puncture) were recorded and treated.
|
|
Gastrointestinal disorders
nausea and vomiting
|
3.3%
1/30 • Number of events 1 • Postoperative 48h adverse effects such as nausea, vomiting, hypotension, hypoxemia, cardiac arrhythmia and the complications from the drugs and technique (local anesthetic toxicity, vascular puncture) were recorded and treated.
|
6.7%
2/30 • Number of events 2 • Postoperative 48h adverse effects such as nausea, vomiting, hypotension, hypoxemia, cardiac arrhythmia and the complications from the drugs and technique (local anesthetic toxicity, vascular puncture) were recorded and treated.
|
Additional Information
Dr. Jun Zhang
Huashan Hospital, Fudan University, Shanghai
Phone: 0086-021-52887694
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place