NCT05822414

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

May 4, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2024

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

1.6 years

First QC Date

April 10, 2023

Last Update Submit

December 16, 2024

Conditions

Rotator Cuff Injuries

Outcome Measures

Primary Outcomes (2)

  • 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)

    one hour and 24-hour after surgery

  • Assessment of diaphragm movement after block performance

    Diaphragm movement evaluated by ultrasonography

    before surgery and one hour after surgery

Secondary Outcomes (1)

  • Assessment of postoperative quality of recovery

    before surgery and 24 hours after surgery

Study Arms (2)

Erector Spinae Plane Block group

EXPERIMENTAL
Procedure: Erector spinae plane block

Superior Trunk Block group

ACTIVE COMPARATOR
Procedure: Erector spinae plane block

Interventions

Erector spinae plane blockPROCEDURE

Erector spinae plane block will be injected at the second thoracic vertebral level for patient undergoing rotator cuff repair surgery

Erector Spinae Plane Block groupSuperior Trunk Block group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients receiving arthroscopic shoulder surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (7)

  • 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.

    PMID: 31490292BACKGROUND

  • 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.

    PMID: 28968280BACKGROUND

  • 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.

    PMID: 29134518BACKGROUND

  • 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.

    PMID: 34861745BACKGROUND

  • 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.

    PMID: 33155041BACKGROUND

  • 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.

    PMID: 34667649BACKGROUND

  • 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.

    PMID: 23411725BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Chun-Yu Wu, MD

    National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2023

First Posted

April 20, 2023

Study Start

May 4, 2023

Primary Completion

December 11, 2024

Study Completion

December 11, 2024

Last Updated

December 19, 2024

Record last verified: 2024-12

Locations

TW(1)