Rotator Cuff InjuriesNCT05822414
ESP vs STB for Pain and Diaphragm Function for Shoulder Surgery
A study testing Erector spinae plane block in people with Rotator Cuff Injuries, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- Erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 May 2023to 11 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients receiving arthroscopic shoulder surgery
Who cannot join
- patients with age <18 and >85
- pregnancy
- patients with severe organ failure: respiratory failure (FEV1 (Forced expiratory volume) /FVC (forced vital capacity)<70% and FEV1< 50%), heart failure (NYHA class III, IV), renal failure (eGFR<60ml/min/1.73m^2)
- patients diagnosed with chronic obstructive lung disease
- patients with arrhythmia
- patients with ongoing infection
- patients with chronic opioid use or substance abuse history
- patients with coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block vs. Superior Trunk Block for Postoperative Pain Control After Arthroscopic Shoulder Surgery: a Randomized Controlled Trial
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
Read the detailed description
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)
- Conditions
- Rotator Cuff Injuries
- Being tested
- Erector spinae plane block
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockProcedure or surgery
Erector spinae plane block will be injected at the second thoracic vertebral level for patient undergoing rotator cuff repair surgery
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block group | Experimental | Not described Receives: Procedure: Erector spinae plane block |
| Superior Trunk Block group | Active comparator | Not described Receives: Procedure: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: one hour and 24-hour after surgery
Assessment of diaphragm movement after block performance
Diaphragm movement evaluated by ultrasonography
Measured: before surgery and one hour after surgery
Secondary outcomes (1)
Assessment of postoperative quality of recovery
Postoperative quality of recovery evaluated by quality of recovery 15 (QoR-15)
Measured: before surgery and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start4 May 2023
- Primary completion11 Dec 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Yu Wu, MD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822414
- Sponsor's protocol ID
- 202301211RINB
- Status last verified
- Dec 2024
- First submitted
- 10 Apr 2023
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hussain N, Goldar G, Ragina N, Banfield L, Laffey JG, Abdallah FW. Suprascapular and Interscalene Nerve Block for Shoulder Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2017 Dec;127(6):998-1013. doi: 10.1097/ALN.0000000000001894.
PubMed 28968280Forero M, Rajarathinam M, Adhikary SD, Chin KJ. Erector spinae plane block for the management of chronic shoulder pain: a case report. Can J Anaesth. 2018 Mar;65(3):288-293. doi: 10.1007/s12630-017-1010-1. Epub 2017 Nov 13.
PubMed 29134518Shanthanna H, Czuczman M, Moisiuk P, O'Hare T, Khan M, Forero M, Davis K, Moro J, Vanniyasingam T, Foster G, Thabane L, Alolabi B. Erector spinae plane block vs. peri-articular injection for pain control after arthroscopic shoulder surgery: a randomised controlled trial. Anaesthesia. 2022 Mar;77(3):301-310. doi: 10.1111/anae.15625. Epub 2021 Dec 3.
PubMed 34861745Ciftci B, Ekinci M, Golboyu BE, Kapukaya F, Atalay YO, Kuyucu E, Demiraran Y. High Thoracic Erector Spinae Plane Block for Arthroscopic Shoulder Surgery: A Randomized Prospective Double-Blind Study. Pain Med. 2021 Apr 20;22(4):776-783. doi: 10.1093/pm/pnaa359.
PubMed 33155041Padua R, de Girolamo L, Grassi A, Cucchi D. Choosing patient-reported outcome measures for shoulder pathology. EFORT Open Rev. 2021 Sep 14;6(9):779-787. doi: 10.1302/2058-5241.6.200109. eCollection 2021 Sep.
PubMed 34667649Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
PubMed 23411725Kang R, Jeong JS, Chin KJ, Yoo JC, Lee JH, Choi SJ, Gwak MS, Hahm TS, Ko JS. Superior Trunk Block Provides Noninferior Analgesia Compared with Interscalene Brachial Plexus Block in Arthroscopic Shoulder Surgery. Anesthesiology. 2019 Dec;131(6):1316-1326. doi: 10.1097/ALN.0000000000002919.
PubMed 31490292
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block vs. Superior Trunk Block for Postoperative Pain Control After Arthroscopic Shoulder Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05822414
- Acronym / sponsor ID
- 202301211RINB
- Conditions
- Rotator Cuff Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block group | Experimental | Procedure: Erector spinae plane block |
| Superior Trunk Block group | Active comparator | Procedure: Erector spinae plane block |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients receiving arthroscopic shoulder surgery
Key exclusion criteria (8 listed)
- patients with age <18 and >85
- pregnancy
- patients with severe organ failure: respiratory failure (FEV1 (Forced expiratory volume) /FVC (forced vital capacity)<70% and FEV1< 50%), heart failure (NYHA class III, IV), renal failure (eGFR<60ml/min/1.73m^2)
- patients diagnosed with chronic obstructive lung disease
- patients with arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector spinae plane blockErector spinae plane block will be injected at the second thoracic vertebral level for patient undergoing rotator cuff repair surgery | Procedure or surgery | Erector Spinae Plane Block group, Superior Trunk Block group |
Primary outcome
Assessment of postoperative pain severity
Time frame: one hour and 24-hour after surgery
Postoperative pain severity evaluated by 100mm-visual analogue scale (0-100; 0 means no pain at all and 100 means the worst pain intensity)
Assessment of diaphragm movement after block performance
Time frame: before surgery and one hour after surgery
Diaphragm movement evaluated by ultrasonography
1 secondary outcome
Assessment of postoperative quality of recovery
Time frame: before surgery and 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Background: PubMed 28968280Hussain N, Goldar G, Ragina N, Banfield L, Laffey JG, Abdallah FW. Suprascapular and Interscalene Nerve Block for Shoulder Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2017 Dec;127(6):998-1013. doi: 10.1097/ALN.0000000000001894.
- Background: PubMed 29134518Forero M, Rajarathinam M, Adhikary SD, Chin KJ. Erector spinae plane block for the management of chronic shoulder pain: a case report. Can J Anaesth. 2018 Mar;65(3):288-293. doi: 10.1007/s12630-017-1010-1. Epub 2017 Nov 13.
- Background: PubMed 34861745Shanthanna H, Czuczman M, Moisiuk P, O'Hare T, Khan M, Forero M, Davis K, Moro J, Vanniyasingam T, Foster G, Thabane L, Alolabi B. Erector spinae plane block vs. peri-articular injection for pain control after arthroscopic shoulder surgery: a randomised controlled trial. Anaesthesia. 2022 Mar;77(3):301-310. doi: 10.1111/anae.15625. Epub 2021 Dec 3.
- Background: PubMed 33155041Ciftci B, Ekinci M, Golboyu BE, Kapukaya F, Atalay YO, Kuyucu E, Demiraran Y. High Thoracic Erector Spinae Plane Block for Arthroscopic Shoulder Surgery: A Randomized Prospective Double-Blind Study. Pain Med. 2021 Apr 20;22(4):776-783. doi: 10.1093/pm/pnaa359.
- Background: PubMed 34667649Padua R, de Girolamo L, Grassi A, Cucchi D. Choosing patient-reported outcome measures for shoulder pathology. EFORT Open Rev. 2021 Sep 14;6(9):779-787. doi: 10.1302/2058-5241.6.200109. eCollection 2021 Sep.
- Background: PubMed 23411725Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
- Results publication: PubMed 31490292Kang R, Jeong JS, Chin KJ, Yoo JC, Lee JH, Choi SJ, Gwak MS, Hahm TS, Ko JS. Superior Trunk Block Provides Noninferior Analgesia Compared with Interscalene Brachial Plexus Block in Arthroscopic Shoulder Surgery. Anesthesiology. 2019 Dec;131(6):1316-1326. doi: 10.1097/ALN.0000000000002919.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Yu Wu, MD study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block in people with Rotator Cuff Injuries, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of postoperative pain severity (time frame: one hour and 24-hour after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05822414, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024; AzTrials last refreshed its copy on 29 Oct 2026.