An interventional study of Erector spinae plane block in Rotator Cuff Injuries, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
To compare the efficacy of pain control, shoulder function recovery, and degree of diaphragm palsy between erector spinae plane block at T2 level and superior trunk block after arthroscopic shoulder surgery
Arthroscopic shoulder surgery can cause a substantial degree of postoperative pain that interferes with postoperative recovery. Adequate perioperative pain control can not only decrease duration of hospital length of stay and prevent unnecessary re-admission, but also facilitate postoperative rehabilitation and improve overall quality of life.
According to the 2019 PROSPECT guideline for rotator cuff repair surgery: systematic review and procedure-specific postoperative pain management recommendations, published on Anesthesia, postoperative pain can be controlled by systemic analgesics such as paracetamol and NSAIDS, regional analgesia, and opioids as rescue analgesia.
The current nerve block of choice is the interscalene brachial plexus block. It can provide adequate pain control, but is associated with several drawbacks including neurological injuries from direct nerve contact and pneumothorax, with the potential for phrenic nerve blockade and hemidiaphragmatic paresis raising the most concern. The superior trunk block, which is performed at where the C5 and C6 roots converge to form the superior trunk, was therefore developed, as it is located further away from the phrenic nerve. However, there are still considerable risks of phrenic nerve blockade, as well as nerve injury from direct contact and upper limb motor blockade.
The erector spinae plane block, first described by Forero et al. in 2016, involves the injection of local anaesthetic deep to the erector spinae muscles and has been widely studied for analgesia in thoracic surgery. It is a paraspinal fascial plane block and is assumed to share the same mechanism at different vertebral levels, including cervical and lumbar, to provide analgesia for a variety of different surgeries, including spine and breast surgeries. In recent years, erector spinae plane block performed at T2 level has also been employed for chronic shoulder pain and arthroscopic shoulder surgery perioperative pain management. Significant better perioperative pain control was achieved when compared with sham block using normal saline by Cftci et al. in 2021 and non inferior pain control was achieved when compared with peri-articular injection of local anesthetics by Shanthanna et al in 2022.
To date, there is no head to head trial comparing the effect of the established block of choice, interscalene brachial plexus block or superior trunk block, to the more novel T2 erector spinae plane block. We therefore designed this study to compare the use of superior trunk block and T2 erector spinae plane block in arthroscopic shoulder surgery with respect to their respective analgesic efficacy and undesired side effect of hemidiaphragm palsy. Primary outcomes of the study are postoperative pain score evaluated by the 100mm-visual analogue scale and morphine consumption, and diaphragm excursion assessed with ultrasonography, while the secondary outcomes include patient reported outcomes assessed by Quality of Recovery-15 (QOR-15) and Shoulder Pain and Disability Index (SPADI)
734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 538 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: Erector spinae plane block
Procedure: Erector spinae plane block
Erector spinae plane block will be injected at the second thoracic vertebral level for patient undergoing rotator cuff repair surgery
Assessment of postoperative pain severity
Postoperative pain severity evaluated by 100mm-visual analogue scale (0-100; 0 means no pain at all and 100 means the worst pain intensity)
Time frame: one hour and 24-hour after surgery
Assessment of diaphragm movement after block performance
Diaphragm movement evaluated by ultrasonography
Time frame: before surgery and one hour after surgery
Assessment of postoperative quality of recovery
Postoperative quality of recovery evaluated by quality of recovery 15 (QoR-15)
Time frame: before surgery and 24 hours after surgery
Plan to share: Undecided
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Taiwan University Hospital