Trial Outcomes & Findings for Ultrasound-Assisted Paravertebral Block v. Traditional Paravertebral Block For Pain Control (NCT NCT01949480)
NCT ID: NCT01949480
Last Updated: 2019-01-22
Results Overview
Hydromorphone (Dilaudid) consumption or opiate equivalent at 24-hour interval post PCA initiation at the post-anesthesia care unit (PACU).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
24 hours after patient-controlled analgesia (PCA) was initiated
Results posted on
2019-01-22
Participant Flow
From July 1, 2013- May 29 2014, 45 patients scheduled for thoracic surgery were approached in the preoperative setting and consented for the study.
3 of the 45 consented patients were excluded because they did not meet inclusion criteria
Participant milestones
| Measure |
Traditional Approach Paravertebral Nerve Block
After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
Ultrasound Assisted Paravertebral Nerve Block
The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
|
Overall Study
COMPLETED
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
Reasons for withdrawal
| Measure |
Traditional Approach Paravertebral Nerve Block
After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
Ultrasound Assisted Paravertebral Nerve Block
The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
|---|---|---|
|
Overall Study
Physician Decision
|
5
|
8
|
Baseline Characteristics
Ultrasound-Assisted Paravertebral Block v. Traditional Paravertebral Block For Pain Control
Baseline characteristics by cohort
| Measure |
Traditional Approach Paravertebral Nerve Block
n=20 Participants
After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
Ultrasound Assisted Paravertebral Nerve Block
n=22 Participants
The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
64 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
22 participants
n=7 Participants
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours after patient-controlled analgesia (PCA) was initiatedPopulation: There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.
Hydromorphone (Dilaudid) consumption or opiate equivalent at 24-hour interval post PCA initiation at the post-anesthesia care unit (PACU).
Outcome measures
| Measure |
Traditional Approach Paravertebral Nerve Block
n=15 Participants
After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
Ultrasound Assisted Paravertebral Nerve Block
n=13 Participants
The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
|---|---|---|
|
Opioid Consumption at 24 Hours Postoperatively
|
5.75 mg
Interval 3.9 to 7.59
|
6.38 mg
Interval 4.09 to 8.66
|
SECONDARY outcome
Timeframe: 6 assessments starting 5 minutes after nerve block and ending 30 minutes after nerve block.Population: There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.
Sensory level as assessed by temperature and pin prick test assessed every 5 min for 30 min after nerve block as defined as the patient returning to their bed. Data below are in number of patients who didn't have any change during the ice and pin prik test.
Outcome measures
| Measure |
Traditional Approach Paravertebral Nerve Block
n=15 Participants
After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
Ultrasound Assisted Paravertebral Nerve Block
n=13 Participants
The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
|---|---|---|
|
Sensory Level
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 hours post PCA initiationPopulation: There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.
The pain level assessed using an 11-point numerical rating scale (NRS) with 0 indicating no pain and 10 indicating the worst pain possible with deep breathing and rest at 24 hours post PCA initiation.
Outcome measures
| Measure |
Traditional Approach Paravertebral Nerve Block
n=15 Participants
After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
Ultrasound Assisted Paravertebral Nerve Block
n=13 Participants
The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
|---|---|---|
|
Pain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing
NRS at rest after 24 hrs
|
1.73 units on a scale
Interval 1.04 to 2.43
|
2.92 units on a scale
Interval 1.99 to 3.86
|
|
Pain 11-point Numerical Rating Scale (NRS)at Rest and With Deep Breathing
NRS during deep inspiration at 24 hrs
|
4 units on a scale
Interval 2.58 to 5.42
|
4.77 units on a scale
Interval 3.56 to 5.98
|
SECONDARY outcome
Timeframe: 24 hours postoperativelyPopulation: There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.
The number of local anesthetic boluses over 24- hour period post PCA initiation will also be recorded.
Outcome measures
| Measure |
Traditional Approach Paravertebral Nerve Block
n=15 Participants
After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
Ultrasound Assisted Paravertebral Nerve Block
n=13 Participants
The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
|---|---|---|
|
Number of Local Anesthetic Boluses Requested by PCA
|
27.5 Number of boluses requested
Interval 13.5 to 57.2
|
48 Number of boluses requested
Interval 17.0 to 63.0
|
SECONDARY outcome
Timeframe: 24 hours postoperativelyPopulation: There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.
The total local anesthetic infusions over 24- hour period.
Outcome measures
| Measure |
Traditional Approach Paravertebral Nerve Block
n=15 Participants
After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
Ultrasound Assisted Paravertebral Nerve Block
n=13 Participants
The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
|---|---|---|
|
Total Local Anesthetic Infusions Over 24- Hour Period
|
173 mL
Interval 168.0 to 184.0
|
186 mL
Interval 175.0 to 197.0
|
SECONDARY outcome
Timeframe: Pre-operatively and at 24 hour post-operativePopulation: There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.
Inspired oxygen concentration and SpO2 preoperatively and at 24 - hour interval. Value reported is an average of the preoperative and the 24-hour postoperative SpO2 measurements.
Outcome measures
| Measure |
Traditional Approach Paravertebral Nerve Block
n=15 Participants
After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
Ultrasound Assisted Paravertebral Nerve Block
n=13 Participants
The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
|---|---|---|
|
Inspired Oxygen Concentration and Blood Oxygen Saturation (SpO2)
|
95 Percentage of SpO2
Interval 94.0 to 96.0
|
94 Percentage of SpO2
Interval 93.0 to 95.0
|
SECONDARY outcome
Timeframe: Preoperatively and PostoperativelyPopulation: There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.
Inspiratory Volume as measured by incentive spirometer preoperatively and at 24 hours post PCA initiation. The data is reported as a percentage in change from per-surgery measurements (post-surgery/pre-surgery).
Outcome measures
| Measure |
Traditional Approach Paravertebral Nerve Block
n=15 Participants
After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
Ultrasound Assisted Paravertebral Nerve Block
n=13 Participants
The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
|---|---|---|
|
Incentive Spirometry
|
0.658 percentage in change from per-surgery
Interval 0.544 to 0.773
|
0.716 percentage in change from per-surgery
Interval 0.575 to 0.857
|
SECONDARY outcome
Timeframe: 24 hours postoperativelyPopulation: There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.
Respiratory rate (RR) per minute after surgery.
Outcome measures
| Measure |
Traditional Approach Paravertebral Nerve Block
n=15 Participants
After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
Ultrasound Assisted Paravertebral Nerve Block
n=13 Participants
The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
|---|---|---|
|
Respiratory Rate
|
17 breaths per one minute
Interval 15.8 to 18.2
|
17.7 breaths per one minute
Interval 15.9 to 19.5
|
SECONDARY outcome
Timeframe: Preoperatively and postoperativelyPopulation: There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.
Forced vital capacity (FVC) measured preoperatively and at 24 - hour interval. Then values were analyzed as percentage in change from per-surgery measurement (post-surgery/pre-surgery).
Outcome measures
| Measure |
Traditional Approach Paravertebral Nerve Block
n=15 Participants
After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
Ultrasound Assisted Paravertebral Nerve Block
n=13 Participants
The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
|---|---|---|
|
Forced Vital Capacity (FVC)
|
0.551 percentage in change from per-surgery
Interval 0.403 to 0.699
|
0.504 percentage in change from per-surgery
Interval 0.395 to 0.613
|
SECONDARY outcome
Timeframe: Preoperatively and postoperativelyPopulation: There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.
Forced expiratory volume in 1 sec (FEV1) preoperatively and at 24 - hour interval. Then the values were analyzed as percentage in change from per-surgery measurement (post-surgery/pre-surgery).
Outcome measures
| Measure |
Traditional Approach Paravertebral Nerve Block
n=15 Participants
After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
Ultrasound Assisted Paravertebral Nerve Block
n=13 Participants
The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
|---|---|---|
|
Forced Expiratory Volume in 1 Sec (FEV1)
|
0.561 percentage in change from per-surgery
Interval 0.4 to 0.722
|
0.571 percentage in change from per-surgery
Interval 0.466 to 0.675
|
SECONDARY outcome
Timeframe: Preoperatively and postoperativelyPopulation: There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.
Peak expiratory flow rate preoperatively (PEF) and at 24 - hour interval. Then values were analyzed as percentage in change from per-surgery measurement (post-surgery/pre-surgery).
Outcome measures
| Measure |
Traditional Approach Paravertebral Nerve Block
n=15 Participants
After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
Ultrasound Assisted Paravertebral Nerve Block
n=13 Participants
The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
|---|---|---|
|
Peak Expiratory Flow Rate(PEF)
|
0.568 percentage in change from per-surgery
Interval 0.4 to 0.735
|
0.542 percentage in change from per-surgery
Interval 0.42 to 0.664
|
SECONDARY outcome
Timeframe: postoperatively, up to 24 hoursPopulation: There are only 13 participants in the Ultrasound Assisted paravertebral nerve block arm, because (n=1) 1 participant was excluded from analysis due to shoulder dislocation during surgical positioning.
Total Number of Local Anesthetic bolus doses given within the 24-hours post-operatively.
Outcome measures
| Measure |
Traditional Approach Paravertebral Nerve Block
n=15 Participants
After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
Ultrasound Assisted Paravertebral Nerve Block
n=13 Participants
The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
|---|---|---|
|
Total Number of Local Anesthetic Boluses in 24 Hours
|
1 number of boluses
Interval 0.0 to 1.5
|
2 number of boluses
Interval 1.0 to 4.0
|
Adverse Events
Traditional Approach Paravertebral Nerve Block
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Ultrasound Assisted Paravertebral Nerve Block
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Traditional Approach Paravertebral Nerve Block
n=20 participants at risk
After final needle placement, a hanging drop technique will be used to rule out intrapleural placement while the patient inhales and exhales deeply. After correct needle placement, 10 mL of 0.5% Ropivacaine will be injected incrementally through each needle after negative aspiration, followed by insertion of the nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in between, through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
Ultrasound Assisted Paravertebral Nerve Block
n=22 participants at risk
The 22 gauge catheter will be threaded through the needle and placed at previously found distance to paravertebral space on obtained ultrasound image. An additional 10 ml of 0.5% Ropivacaine will be administered through the catheter yielding a total activation dose of 20 ml of 0.5% Ropivacaine. The catheter will be secured with Steri-strips and a transparent occlusive dressing.
Thoracotomy
Video-Assisted Thoracoscopic Surgery (VATS)
|
|---|---|---|
|
Surgical and medical procedures
Catheter leaking
|
10.0%
2/20 • Number of events 2 • Adverse events collected for 24 hours post-operatively
If the adverse event (AE) resulted in prolonged hospitalization, serious illness or death, it would be considered a Serious Adverse Event (SAE).
|
13.6%
3/22 • Number of events 3 • Adverse events collected for 24 hours post-operatively
If the adverse event (AE) resulted in prolonged hospitalization, serious illness or death, it would be considered a Serious Adverse Event (SAE).
|
Additional Information
Dr. Anna Uskova, Principal Investigator
University of Pittsburgh
Phone: 412) 623-2167
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place