Abstract
BackgroundThe innervation of the shoulder-upper-extremity area is complicated and unclear. Regional anesthesia with a brachial plexus and cervical plexus block is probably inadequate for the proximal humeral surgery. Missing blockade of the T1–T2 nerves may be the reason. We conduct this prospective randomized controlled trial (RCT) to explore whether an additional T2 thoracic paravertebral block (TPVB) can improve the success rate of regional anesthesia for elderly patients in proximal humeral fracture surgery.Methods/designThe patients aged 65 years or older, referred for anterior-approach proximal humeral fracture surgery, will be enrolled. Each patient will be randomly assigned 1:1 to receive a combined interscalene brachial plexus with superficial cervical plexus block (IC) (combined interscalene brachial plexus with superficial cervical plexus block) or an IC block combined with thoracic paravertebral block (ICTP) block (combined thoracic paravertebral block with brachial plexus and superficial cervical plexus block). The primary outcome is the success rate of regional anesthesia without rescue analgesic methods. The secondary outcomes are as follows: sensory block at the surgical area, proportion of patients who need rescue anesthesia (intravenously administered remifentanil or conversion to general anesthesia), cumulative doses of intraoperative vasoactive medications and adverse events. The total sample size is estimated to be 80 patients.DiscussionThis RCT aims to confirm whether an additional T2 TPVB can provide better anesthetic effects of regional anesthesia with brachial and cervical plexus block in elderly patients undergoing proximal humeral surgery.Trial registrationClinicalTrials.gov, ID: NCT03919422. Registered on 19 April 2019.
Highlights
The innervation of the shoulder-upper-extremity area is complicated and unclear
This randomized controlled trial (RCT) aims to confirm whether an additional T2 thoracic paravertebral block (TPVB) can provide better anesthetic effects of regional anesthesia with brachial and cervical plexus block in elderly patients undergoing proximal humeral surgery
Our pilot study found that 40% of patients who received an IC block complained of pain and needed intravenously administered (IV) narcotics or local infiltration, even conversion to general anesthesia
Summary
Ultrasound-guided brachial plexus and cervical plexus block is probably inadequate for the anesthesia of proximal humeral-fracture surgery. We intend to block the branches of the T1–T2 segments by T2 TPVB In this trial, our primary purpose is to evaluate the anesthetic effects of additional T2 TPVB in the elderly patients undergoing proximal humeral surgery. The results can help us to determine the indispensability of this potentially risky technique This trial should enable us to better assess the effectiveness of regional anesthesia in the elderly population undergoing proximal humeral fracture, with the potential possibility of avoiding opioids or general anesthesia. It may provide us an with ideal combination of nerve blocks for the surgery at the boundary of the shoulder-upper-extremity area. The recruitment was began on 5 May 2019 and is expected to be completed in April 2020
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