Effectiveness of Additional Thoracic Paravertebral Block in Improving Anesthetic Effects of Regional Anesthesia for Proximal Humeral Fracture Surgery in Elderly Patients: Study Protocol for a Randomized Controlled Trial
Phase: NA
Conditions: Proximal Humeral Fracture
Sponsor: Shanghai 6th People's Hospital

Shanghai 6th people’s hospital 
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Effectiveness of additional thoracic paravertebral block in 
improving anesthetic effects of regional anesthesia for 
proximal humeral fracture surgery in elderly patients 
Study Protocol 
2019.3.21 
Principle Investigator: Xiaofeng Wang, MD 
Co-Investigator: Hui Zhang, MD 
Junling Liao, MD 
Zhenwei Xie, MD 
Yongzhu Chen, MD 
Qingfu Zhang, MD 
Wei Jiang, MD, PhD 
Junfeng Zhang, MD,PhD 
 
 
 

Shanghai 6th people’s hospital 
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Objective 
To investigate whether supplementary T2 thoracic paravertebral block (TPVB) 
could improve the anesthetic effect of cervical-brachial plexus block based regional 
block. 
Background 
Proximal humeral fractures (PHF) is a common disease occurring in the elderly 
population over 60 years. The deltopectoral approach is commonly used in the PHF 
surgery. The innervation of PHF surgical area is complicated and unclear. Ultrasound-
guided brachial plexus combined with cervical plexus block is probably inadequate for 
the anesthesia of proximal humeral surgery. Missing blockade of T1-T2 nerves may be 
the reason. The primary aim of this trial is to investigate the effectiveness of additional 
T2 thoracic paravertebral block (TPVB) in improving the anesthetic effects of regional 
anesthesia for elderly patients in proximal humeral fracture surgery. 
Methods 
We have designed a two-armed, parallel, randomized controlled trial (RCT) to 
observe the anesthetic effects of ultrasound-guided brachial and cervical plexus block 
with or without additional T2 TPVB in terms of the following outcomes: success rate, 
sensory block and safety. The elderly patients aged 65 or older, referred for anterior 
approach proximal humeral fracture surgery, will be enrolled. Each participant will be 
randomly assigned 1:1 to receive IC block (combined interscalene brachial plexus with 
superficial cervical plexus block) or ICTP block (combined thoracic paravertebral block 
with IC block). The primary outcome is the success rate of surgical anesthesia. The 
secondary outcomes are as follows: sensory block at surgical area, proportion of 
participants who need supplementary anesthesia (intravenous remifentanil or 
conversion to general anesthesia), cumulative doses of intraoperative vasoactive 
medications and adverse events. The necessary sample size is estimated to be 80. 
 
 
 

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Randomization and blinding 
Random allocation will be performed by a researcher (HZ) before the trial using a 
randomization sequence. The allocation concealment strategy is achieved with 
sequentially numbered, opaque, sealed envelopes to conceal the sequence until the 
intervention is assigned. The envelopes will be opened sequentially before the nerve 
block is performed. Participants will be randomly assigned in a 1:1 ratio to receive IC 
block or ICTP block. As the nerve block intervention cannot be blinded from 
participants and staff implementing the intervention, only the outcome assessor and 
data statistician will be kept blinded to the randomized allocation and intervention. The 
envelope will be resealed after confirming the allocation.  
 
Interventions 
All the participants will undergo preoperative fasting for 8 hours and water 
deprivation for 2 hours. After placement of standard ASA monitors, intravenous access 
for fluid infusion will be established in the forearm. No sedatives or analgesic 
medication will be given prior to the block. The participant will receive ultrasound-
guided IC block or ICTP block according to the allocation. It will be performed 
following standard skin disinfection with a SonoSite S-NerveTM ultrasound machine 
(Bothell, WA, USA). The entire nerve block procedure of all the participants will be 
performed by the same anesthesiologist, who is skilled in performing ultrasound-guided 
regional anesthesia. 
In the IC group, the procedure will be performed as followed. 
The participant will be placed in the lateral decubitus position with the operative 
side upwards. A linear array transducer (6-13 MHz) with a sterile cover and a 22G 
(gauge) block needle will be used. An in-plane approach, advancing the needle along 
the longitudinal axis of the transducer and visualizing the entire shaft, will be employed. 
Twenty ml of 0.375% ropivacaine will be injected between superior and middle trunk 
of brachial plexus at C7 level to reduce phrenic nerve palsy. The transducer will be then 
moved cephalad until the superficial cervical plexus emerges from the C4 intervertebral 
foramen. Ten ml of 0.25% ropivacaine will be injected to block the nerve. 

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In the ICTP group, the procedure will be performed as followed. 
On the basis of IC block, T2 TPVB will then be performed. The T2-T3 
intervertebral space should be determined by ultrasound image scanning and palpation 
counting from C7 spinous process. A curve array transducer (2-5 MHz) will be placed 
at the T2-T3 intercostal level with a slightly oblique scan to visualize the transverse 
process, costotransverse ligament, internal intercostal membrane and parietal pleura. A 
10cm, 22G needle will be introduced into the thoracic paravertebral space beyond the 
internal intercostal membrane with its tip positioned outside the transverse process. 
Following negative aspiration of air, blood or cerebrospinal fluid in the needle, 10 ml 
of 0.25% ropivacaine will be injected into the paravertebral space. 
Then the participant will be placed in the supine position. Twenty minutes later, 
after the sensory block assessed, the participant will be transferred to the operating 
room and placed in a beach-chair position. One mg midazolam will be given 
intravenously. Oxygen will be routinely given via a nasal catheter at the flow rate of 
3L/min until the end of operation. In case of inadequate analgesia, remifentanil (50μ
g/ml), propofol (10mg/ml) and laryngeal mask airway (LMA) insertion will be prepared. 
The anesthetic effects will be assessed since the operation begin: 1) if it is successful, 
the operation will be continued; 2) if it is failed, the operation will be paused and 
remifentanil will be given intravenous at the rate of 0.25μg/kg/min. Two minutes later, 
the operation will be continued if the participant is satisfied with the anesthetic effect. 
The rate of intravenous remifentanil can be appropriately regulated (no more than 
0.25μg/kg/min) in the following operation according to the PETCO2 and respiratory rate 
of the participant. On the contrary, the intolerable participant will be induced with 
propofol (1.5-2 mg/kg) for converting to GA with LMA. The participant who received 
GA will be transferred to post-anesthesia care unit (PACU) after the operation. 
 
Statistical analysis plan 
Primary analyses will be undertaken on an intention-to-treat basis, including all 
participants as randomized, except whose who withdraw consent for the use of their 

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data. Data will be expressed as mean ± standard deviation (SD), median (interquartile 
range), or percentage. Continuous variables will be analyzed with a two-sample t test 
with equal/unequal variance or with a Mann and Whitney U test, if appropriate. A chi-
square test or Fisher’s exact test will be used for categorical variables. The statistical 
analysis will be performed using SPSS V.24.0 (IBM Corporation, Armonk, New York, 
USA) with a significance level of 0.05.