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ESPB vs STB for Shoulder Surgery

Primary Purpose

Rotator Cuff Injuries

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Erector spinae plane block
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Injuries

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients receiving arthroscopic shoulder surgery patients with BMI between 18.5 kg/m^2 and 30 kg/m^2 Exclusion Criteria: patients with age <18 and >85 pregnancy patients with severe organ failure: respiratory failure (FEV1/FVC<70% and FEV1< 50%), heart failure (NYHA class III, IV), renal failrue (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

Sites / Locations

  • National Taiwan University HospitalRecruiting
  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Erector Spinae Plane Block group

Superior Trunk Block group

Arm Description

Outcomes

Primary Outcome Measures

Assessment of postoperative pain severity
Postoperative pain severity evaluated by 100mm-visual analogue scale
Assessment of diaphragm movement after block performance
Diaphragm movement evaluated by ultrasonography

Secondary Outcome Measures

Assessment of postoperative quality of recovery
Postoperative quality of recovery evaluated by quality of recovery 15 (QoR-15)
Assessment of postoperative shoulder function
Postoperative shoulder function evaluated by Shoulder Pain and Disability Index (SPADI)

Full Information

First Posted
April 10, 2023
Last Updated
April 10, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05822414
Brief Title
ESPB vs STB for Shoulder Surgery
Official Title
Erector Spinae Plane Block vs. Superior Trunk Block for Postoperative Pain Control After Arthroscopic Shoulder Surgery: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erector Spinae Plane Block group
Arm Type
Experimental
Arm Title
Superior Trunk Block group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Intervention Description
Erector spinae plane block will be injected at the second thoracic vertebral level for patient undergoing rotator cuff repair surgery
Primary Outcome Measure Information:
Title
Assessment of postoperative pain severity
Description
Postoperative pain severity evaluated by 100mm-visual analogue scale
Time Frame
one hour and 24-hour after surgery
Title
Assessment of diaphragm movement after block performance
Description
Diaphragm movement evaluated by ultrasonography
Time Frame
before surgery and one hour after surgery
Secondary Outcome Measure Information:
Title
Assessment of postoperative quality of recovery
Description
Postoperative quality of recovery evaluated by quality of recovery 15 (QoR-15)
Time Frame
before surgery and 24 hours after surgery
Title
Assessment of postoperative shoulder function
Description
Postoperative shoulder function evaluated by Shoulder Pain and Disability Index (SPADI)
Time Frame
one month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients receiving arthroscopic shoulder surgery patients with BMI between 18.5 kg/m^2 and 30 kg/m^2 Exclusion Criteria: patients with age <18 and >85 pregnancy patients with severe organ failure: respiratory failure (FEV1/FVC<70% and FEV1< 50%), heart failure (NYHA class III, IV), renal failrue (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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun-Yu Wu, MD
Phone
0672653376
Email
b001089018@tmu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Hsin-Yu Yang, MD
Phone
0972655095
Email
cori9086@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Yu Wu, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun-Yu Wu
Phone
0972653376
Email
b001089018@tmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Hsin-Yu Yang
Phone
097655095
Email
cori9086@gmail.com
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun-Yu Wu, MD
Phone
0972653376
Email
b001089018@tmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Hsin-Yu Yang, MD
Phone
0972655095
Email
cori9086@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28968280
Citation
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.
Results Reference
background
PubMed Identifier
29134518
Citation
Forero 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.
Results Reference
background
PubMed Identifier
34861745
Citation
Shanthanna 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.
Results Reference
background
PubMed Identifier
33155041
Citation
Ciftci 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.
Results Reference
background
PubMed Identifier
34667649
Citation
Padua 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.
Results Reference
background
PubMed Identifier
23411725
Citation
Stark 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 Reference
background
PubMed Identifier
31490292
Citation
Kang 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.
Results Reference
result

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ESPB vs STB for Shoulder Surgery

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