NCT04822610

Brief Summary

In this study, the investigators are going to compare the analgesia effectiveness of interscalane block and suprascapular with axillary block in shoulder arthroplasties

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

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

January 19, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 30, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

7 months

First QC Date

January 19, 2021

Last Update Submit

January 31, 2022

Conditions

Shoulder ArthroplastyUltrasound Guided

Keywords

axillary blocksuprascapular block

Outcome Measures

Primary Outcomes (2)

  • Opioid (mg) consumption

    Opioid (mg) consumption

    48 hours

  • Measurement of postoperative pain

    VAS (visual analog scale) (0: no pain, 10: the worst pain imaginable)

    48 hours

Other Outcomes (5)

  • Operation time

    during surgery

  • Hospital stay

    postoperative period up to 3 days

  • Postoperatif complication

    postoperative period up to 3 days

  • +2 more other outcomes

Study Arms (3)

Study group: interscalene block + IV PCA

EXPERIMENTAL

preop usg guided interscalene block and IV PCA

Procedure: interscalene block

Study group: suprascapular block + axillary block + IV PCA

EXPERIMENTAL

preop usg guided suprascapular block + axillary block and IV PCA

Procedure: suprascapular block + axillary block

Control group: IV PCA

NO INTERVENTION

no block + IV PCA

Interventions

interscalene blockPROCEDURE

peripheral nerve block

Study group: interscalene block + IV PCA
suprascapular block + axillary blockPROCEDURE

peripheral nerve block

Study group: suprascapular block + axillary block + IV PCA

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • accepting the study protocol,
  • age older than 18 years and younger than 90 years,
  • undergoing shoulder arthroplasty surgery
  • the American Society of Anesthesiologist (ASA) physical status of I-II-III-IV

You may not qualify if:

  • severe respiratory distress
  • patients with local anesthetic allergy
  • contralateral hemidiaphragmatic parrhesia
  • recurrent laryngeal nerve palsy
  • infection at the injection site
  • coagulation disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Faculty of Medicine

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

Related Publications (4)

  • Toma O, Persoons B, Pogatzki-Zahn E, Van de Velde M, Joshi GP; PROSPECT Working Group collaborators. PROSPECT guideline for rotator cuff repair surgery: systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2019 Oct;74(10):1320-1331. doi: 10.1111/anae.14796. Epub 2019 Aug 7.

    PMID: 31392721BACKGROUND

  • Lee SM, Park SE, Nam YS, Han SH, Lee KJ, Kwon MJ, Ji JH, Choi SK, Park JS. Analgesic effectiveness of nerve block in shoulder arthroscopy: comparison between interscalene, suprascapular and axillary nerve blocks. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2573-8. doi: 10.1007/s00167-012-1950-5. Epub 2012 Mar 21.

    PMID: 22434159BACKGROUND

  • Park JY, Bang JY, Oh KS. Blind suprascapular and axillary nerve block for post-operative pain in arthroscopic rotator cuff surgery. Knee Surg Sports Traumatol Arthrosc. 2016 Dec;24(12):3877-3883. doi: 10.1007/s00167-015-3902-3. Epub 2016 Jan 5.

    PMID: 26733274BACKGROUND

  • Cho N, Kang RS, McCartney CJL, Pawa A, Costache I, Rose P, Abdallah FW. Analgesic benefits and clinical role of the posterior suprascapular nerve block in shoulder surgery: a systematic review, meta-analysis and trial sequential analysis. Anaesthesia. 2020 Mar;75(3):386-394. doi: 10.1111/anae.14858. Epub 2019 Oct 3.

    PMID: 31583679BACKGROUND

Study Officials

  • Kübra Ozkan, MD

    Istanbul Unıversity, Istanbul Faculty of Medicine, Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
open
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study group - Study group- Control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, M.D.

Study Record Dates

First Submitted

January 19, 2021

First Posted

March 30, 2021

Study Start

June 30, 2021

Primary Completion

January 21, 2022

Study Completion

January 31, 2022

Last Updated

February 1, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)