Trial Outcomes & Findings for Paravertebral Block for Proximal Humeral Fracture Surgery (NCT NCT03919422)
NCT ID: NCT03919422
Last Updated: 2021-01-05
Results Overview
Success rate - was equivalent to surgical anesthesia, defined as the ability to proceed with surgery without the need for intravenous narcotics, general anaesthesia, rescue blocks or local infiltration by the surgeon.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
throughout the operation duration, an average of 2 to 3 hours
Results posted on
2021-01-05
Participant Flow
121participants were screened. 41 did not meet criteria.
Participant milestones
| Measure |
IC Group
Interscalene brachial plexus-Cervical plexus
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
ICTP Group
Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Paravertebral Block for Proximal Humeral Fracture Surgery
Baseline characteristics by cohort
| Measure |
IC Group
n=40 Participants
Interscalene brachial plexus-Cervical plexus
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
ICTP Group
n=40 Participants
Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.8 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
74.5 years
STANDARD_DEVIATION 6.5 • n=7 Participants
|
74.7 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
yellow race, Han nationality, China
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
weight
|
60.2 kg
STANDARD_DEVIATION 9.1 • n=5 Participants
|
62.5 kg
STANDARD_DEVIATION 11.3 • n=7 Participants
|
61.3 kg
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
BMI
|
24.3 kg/m^2
STANDARD_DEVIATION 3.2 • n=5 Participants
|
24.4 kg/m^2
STANDARD_DEVIATION 3.8 • n=7 Participants
|
24.4 kg/m^2
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
ASA
ASA I
|
14 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
ASA
ASA II
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
duration of surgery
|
72.5 minutes
n=5 Participants
|
70 minutes
n=7 Participants
|
70 minutes
n=5 Participants
|
|
height
|
157.2 cm
STANDARD_DEVIATION 6.8 • n=5 Participants
|
159.7 cm
STANDARD_DEVIATION 7.2 • n=7 Participants
|
159.7 cm
STANDARD_DEVIATION 7.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: throughout the operation duration, an average of 2 to 3 hoursSuccess rate - was equivalent to surgical anesthesia, defined as the ability to proceed with surgery without the need for intravenous narcotics, general anaesthesia, rescue blocks or local infiltration by the surgeon.
Outcome measures
| Measure |
IC Group
n=40 Participants
Interscalene brachial plexus-Cervical plexus
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
ICTP Group
n=40 Participants
Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
|---|---|---|
|
Success Rate(Ability to Proceed With Surgery Without the Need for Intravenous Narcotics, General Anaesthesia, Rescue Blocks or Local Infiltration by the Surgeon)
|
31 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 20 minutes after all the nerve block operations have been finishedSensory blockade graded from 0 to 2(0= normal sensation, 1= decreased sensation and 2= no perception) by applying pinprick and cold test to the different parts of shoulder
Outcome measures
| Measure |
IC Group
n=40 Participants
Interscalene brachial plexus-Cervical plexus
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
ICTP Group
n=40 Participants
Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
|---|---|---|
|
Assessment of Sensory Blockade
medial part of upper arm · partial block
|
4 Participants
|
17 Participants
|
|
Assessment of Sensory Blockade
distal clavicle area · no block
|
1 Participants
|
0 Participants
|
|
Assessment of Sensory Blockade
distal clavicle area · partial block
|
2 Participants
|
1 Participants
|
|
Assessment of Sensory Blockade
distal clavicle area · complete block
|
37 Participants
|
39 Participants
|
|
Assessment of Sensory Blockade
deltoid area · no block
|
0 Participants
|
0 Participants
|
|
Assessment of Sensory Blockade
deltoid area · partial block
|
3 Participants
|
2 Participants
|
|
Assessment of Sensory Blockade
deltoid area · complete block
|
37 Participants
|
38 Participants
|
|
Assessment of Sensory Blockade
lateral part of upper arm · no block
|
0 Participants
|
0 Participants
|
|
Assessment of Sensory Blockade
lateral part of upper arm · partial block
|
4 Participants
|
3 Participants
|
|
Assessment of Sensory Blockade
lateral part of upper arm · complete block
|
36 Participants
|
37 Participants
|
|
Assessment of Sensory Blockade
medial part of upper arm · no block
|
36 Participants
|
6 Participants
|
|
Assessment of Sensory Blockade
medial part of upper arm · complete block
|
0 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: throughout the operation duration, an average of 2 to 3 hoursWhen the primary outcome of the participant is assessed by "failure" during the surgery, 0.25μg/kg/min remifentanil will be given via intravenous infusion. Two minutes later, the procedure will continue if the participant can tolerate the pain.
Outcome measures
| Measure |
IC Group
n=40 Participants
Interscalene brachial plexus-Cervical plexus
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
ICTP Group
n=40 Participants
Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
|---|---|---|
|
Proportion of Participants Completed the Procedure With Remifentanil
|
13 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: throughout the operation duration, an average of 2 to 3 hoursWhen the primary outcome of the participant is assessed by "failure" during the surgery, 0.25μg/kg/min remifentanil will be given via intravenous infusion. Two minutes later, if the participant cannot tolerate the pain, a general anesthesia with LMA will be given.
Outcome measures
| Measure |
IC Group
n=40 Participants
Interscalene brachial plexus-Cervical plexus
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
ICTP Group
n=40 Participants
Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
|---|---|---|
|
Proportion of Participants Conversed Into General Anesthesia(Laryngeal Mask Airway,LMA)
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At the end of surgical procedure(an average of 2 to 3 hours)Cumulative doses of vasoactive drugs required such as urapidil,atropine, ephedrine during the surgery.
Outcome measures
| Measure |
IC Group
n=40 Participants
Interscalene brachial plexus-Cervical plexus
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
ICTP Group
n=40 Participants
Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
|---|---|---|
|
Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine)
urapidil (mg)
|
1.13 mg
Standard Deviation 2.9
|
1.50 mg
Standard Deviation 3.6
|
|
Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine)
atropine (mg)
|
0.05 mg
Standard Deviation 0.2
|
0.09 mg
Standard Deviation 0.2
|
|
Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine)
ephedrine (mg)
|
1.00 mg
Standard Deviation 3.3
|
0.5 mg
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: At the end of surgical procedure(an average of 2 to 3 hours)Cumulative doses of intravenous deoxyepinephrine required during the surgery.
Outcome measures
| Measure |
IC Group
n=40 Participants
Interscalene brachial plexus-Cervical plexus
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
ICTP Group
n=40 Participants
Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
|---|---|---|
|
Cumulative Doses of Intraoperative Vasoactive Medications (Deoxyepinephrine)
|
5.0 ug
Standard Deviation 18.9
|
7.5 ug
Standard Deviation 29.0
|
SECONDARY outcome
Timeframe: within 24 hours since the nerve block finishedPresence or absence of local anesthetic systemic toxicity, pneumothorax, and epidural block, total spinal block, hematoma
Outcome measures
| Measure |
IC Group
n=40 Participants
Interscalene brachial plexus-Cervical plexus
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
ICTP Group
n=40 Participants
Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
|---|---|---|
|
Complications Related With Anesthesia
local anesthetic systemic toxicity
|
0 Participants
|
0 Participants
|
|
Complications Related With Anesthesia
pneumothorax
|
0 Participants
|
0 Participants
|
|
Complications Related With Anesthesia
epidural block
|
0 Participants
|
0 Participants
|
|
Complications Related With Anesthesia
total spinal block
|
0 Participants
|
0 Participants
|
|
Complications Related With Anesthesia
hematoma
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: throughout the operation duration, an average of 2 to 3 hoursNumber of participants with hypertension, hypotension, bradycardia, tachycardia or dyspnea during the surgery.
Outcome measures
| Measure |
IC Group
n=40 Participants
Interscalene brachial plexus-Cervical plexus
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
ICTP Group
n=40 Participants
Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
|---|---|---|
|
Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea)
Number of participants with hypertension during the surgery
|
6 Participants
|
7 Participants
|
|
Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea)
Number of participants with hypotension during the surgery
|
4 Participants
|
5 Participants
|
|
Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea)
Number of participants with bradycardia during the surgery
|
5 Participants
|
8 Participants
|
|
Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea)
Number of participants with tachycardia druing the surgery
|
0 Participants
|
1 Participants
|
|
Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea)
Number of participants with dyspnea during the surgery
|
5 Participants
|
2 Participants
|
Adverse Events
IC Group
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
ICTP Group
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IC Group
n=40 participants at risk
Interscalene brachial plexus-Cervical plexus
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
ICTP Group
n=40 participants at risk
Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
|---|---|---|
|
Nervous system disorders
local anesthetic systemic toxicity
|
0.00%
0/40 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
0.00%
0/40 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
pneumothorax
|
0.00%
0/40 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
0.00%
0/40 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
|
Nervous system disorders
epidural block
|
0.00%
0/40 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
0.00%
0/40 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
|
Nervous system disorders
total spinal block
|
0.00%
0/40 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
0.00%
0/40 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
|
Vascular disorders
hematoma
|
0.00%
0/40 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
0.00%
0/40 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
Other adverse events
| Measure |
IC Group
n=40 participants at risk
Interscalene brachial plexus-Cervical plexus
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
ICTP Group
n=40 participants at risk
Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
T2 paravertebral block: Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).
interscalene brachial plexus block and superficial cervical plexus block: An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
|
|---|---|---|
|
Cardiac disorders
Hypertension
|
15.0%
6/40 • Number of events 6 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
17.5%
7/40 • Number of events 7 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
|
Cardiac disorders
hypotension
|
10.0%
4/40 • Number of events 4 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
12.5%
5/40 • Number of events 5 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
|
Cardiac disorders
bradycardia
|
12.5%
5/40 • Number of events 5 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
20.0%
8/40 • Number of events 8 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
|
Cardiac disorders
tachycardia
|
0.00%
0/40 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
2.5%
1/40 • Number of events 1 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
12.5%
5/40 • Number of events 5 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
5.0%
2/40 • Number of events 2 • 1day after surgery
Block-related complications such as local anesthetic systemic toxicity, pneumothorax, epidural block, total spinal block and hematoma were defined as Severe Adverse Events. The intraoperative adverse reactions including hypertension, hypotension, bradycardia, tachycardia and dyspnea were defined as Other Adverse Events.
|
Additional Information
Dr. Junfen Zhang, director of the clinical trial
Department of Anesthesiology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Phone: +8618930173689
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place