NCT04101266

Brief Summary

It is compared that combined suprascapular and infraclavicular nerve blocks to interscalene nerve block for clinical outcomes after shoulder surgery

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 Sep 2019

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

September 17, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

September 30, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

September 17, 2019

Last Update Submit

June 7, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • postoperative pain: numeric rating scale (NRS)

    postoperative pain will be evaluated by numeric rating scale (NRS) .

    postoperative 30. minute, 4. hour, 8.hour,12. hour, 24. hour, 48. hour

Secondary Outcomes (1)

  • phrenic nerve paralysis evaluated with ultrasound

    thirty minutes after the nerve block

Study Arms (2)

Interscalene nerve block

ACTIVE COMPARATOR

preoperative interscalene nerve block to be applied with ultrasound guidance.

Other: Interscalene block

suprascapular and infraclavicular nerve block

ACTIVE COMPARATOR

preoperative suprascapular and infraclavicular nerve block to be with ultrasound guidance

Other: suprascapular and infraclavicular nerve block

Interventions

30 minutes before anaesthesia induction interscalene nerve block will be applied with ultrasound guidance with %0,25 bupivacain 20 cc .The sham block consisted of after patients were placed in the lateral decubitus position skin preparation, ultrasound scanning of the suprascapular region, and a dry-needling, all performed to preserve patient blinding in the ISB group patients.

Interscalene nerve block

30 minutes before anaesthesia induction suprascapular with %0,25 bupivacain 10 cc .and infraclavicular nerve block with %0,25 bupivacain 10 cc will be applied with ultrasound guidance

suprascapular and infraclavicular nerve block

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective shoulder surgery under general anesthesia with suprascapular + infraclavicular nerve block or interscalene nerve block for any reason ASA 1-3 patients

You may not qualify if:

  • Diabetes
  • coagulopathy
  • local anesthetic allergy
  • chronic opioid users
  • neurological deficit of the surgical limb
  • obstructive or restrictive pulmoner disease
  • inability to understand pain scores

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diskapi Yildiim Beyazit Eduation and Research Hospital

Ankara, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 24, 2019

Study Start

September 30, 2019

Primary Completion

March 1, 2020

Study Completion

April 1, 2020

Last Updated

June 10, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations