Trial Outcomes & Findings for Assessment of Intercostal Block Scheduling in Preventing Acute Surgical and Post-surgical Pain in Thoracoscopic Surgery (NCT NCT02469610)
NCT ID: NCT02469610
Last Updated: 2019-07-05
Results Overview
The amount of analgesic medication consumption by patients during and after thoracoscopic surgery. the measurement include A. Analgesic usage during the hours of operation and recovery unit (4-8Hr) B. Analgesic usage during postoperative days (first, second, third and fourth for each 24 Hr)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
65 participants
Primary outcome timeframe
post operative
Results posted on
2019-07-05
Participant Flow
Participant milestones
| Measure |
Study
In the study group the surgeon will perform an intercostal Bupivacaine block of 100ml over five intercostal spaces which include the operation cuts. The block will be done in the beginning of the surgery right after the insertion of the video camera to the pleural space.
Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces.
|
Control
In the control group the surgeon will perform the same intercostal block at the end of the surgery just before closing the operation cuts. this approach is used today in our department.
Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
31
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Study
In the study group the surgeon will perform an intercostal Bupivacaine block of 100ml over five intercostal spaces which include the operation cuts. The block will be done in the beginning of the surgery right after the insertion of the video camera to the pleural space.
Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces.
|
Control
In the control group the surgeon will perform the same intercostal block at the end of the surgery just before closing the operation cuts. this approach is used today in our department.
Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
exclusion criteria
|
2
|
1
|
Baseline Characteristics
Assessment of Intercostal Block Scheduling in Preventing Acute Surgical and Post-surgical Pain in Thoracoscopic Surgery
Baseline characteristics by cohort
| Measure |
Study
n=30 Participants
In the study group the surgeon will perform an intercostal Bupivacaine block of 100ml over five intercostal spaces which include the operation cuts. The block will be done in the beginning of the surgery right after the insertion of the video camera to the pleural space.
Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces.
|
Control
n=30 Participants
In the control group the surgeon will perform the same intercostal block at the end of the surgery just before closing the operation cuts. this approach is used today in our department.
Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Age, Continuous
|
64.6 years
n=99 Participants
|
67.4 years
n=107 Participants
|
66 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
30 participants
n=99 Participants
|
30 participants
n=107 Participants
|
60 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: post operativePopulation: the use of opioids in the operative day (post operative day 0)
The amount of analgesic medication consumption by patients during and after thoracoscopic surgery. the measurement include A. Analgesic usage during the hours of operation and recovery unit (4-8Hr) B. Analgesic usage during postoperative days (first, second, third and fourth for each 24 Hr)
Outcome measures
| Measure |
Study
n=30 Participants
In the study group the surgeon will perform an intercostal Bupivacaine block of 100ml over five intercostal spaces which include the operation cuts. The block will be done in the beginning of the surgery right after the insertion of the video camera to the pleural space.
Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces.
|
Control
n=30 Participants
In the control group the surgeon will perform the same intercostal block at the end of the surgery just before closing the operation cuts. this approach is used today in our department.
Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces.
|
|---|---|---|
|
Analgesic Use
|
33.35 MG
Standard Deviation 10.31
|
35.32 MG
Standard Deviation 13.44
|
SECONDARY outcome
Timeframe: post operativePopulation: Visual Analog pain Scale on the first post-operative day. For each patient we calculate the average score of his answers to the question "How do you rate your pain on the Visual Analog pain Scale ?" during the first post-operative day.
subjective patient's pain evaluation according to Visual Analog pain Scale (VAS). Visual Analog pain Scale a 1-10 score of pain. 1 being a lowest level of pain and 10 the worst pain felt by the patient.
Outcome measures
| Measure |
Study
n=30 Participants
In the study group the surgeon will perform an intercostal Bupivacaine block of 100ml over five intercostal spaces which include the operation cuts. The block will be done in the beginning of the surgery right after the insertion of the video camera to the pleural space.
Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces.
|
Control
n=30 Participants
In the control group the surgeon will perform the same intercostal block at the end of the surgery just before closing the operation cuts. this approach is used today in our department.
Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces.
|
|---|---|---|
|
Visual Analog Pain Scale
|
3.53 units on a scale
Standard Deviation 2.64
|
3.63 units on a scale
Standard Deviation 2.64
|
Adverse Events
Study
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Study
n=34 participants at risk
In the study group the surgeon will perform an intercostal Bupivacaine block of 100ml over five intercostal spaces which include the operation cuts. The block will be done in the beginning of the surgery right after the insertion of the video camera to the pleural space.
Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces.
|
Control
n=31 participants at risk
In the control group the surgeon will perform the same intercostal block at the end of the surgery just before closing the operation cuts. this approach is used today in our department.
Intercostal block Bupivacaine based: Intercostal Bupivacaine block of 100ml over five intercostal spaces.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
massive pulmonary emboli
|
2.9%
1/34 • Number of events 1 • 1 months
|
0.00%
0/31 • 1 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place