Pain Management in Arthtroscopic Shoulder Surgery
PMSS
Comparison of the Effects Combined Suprascapular and Infraclavicular Nerve Blocks to Interscalene Nerve Block Applied Arthtroscopic Shoulder Surgery
1 other identifier
interventional
76
1 country
1
Brief Summary
It is compared that combined suprascapular and infraclavicular nerve blocks to interscalene nerve block for clinical outcomes after shoulder surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2019
CompletedFirst Posted
Study publicly available on registry
September 24, 2019
CompletedStudy Start
First participant enrolled
September 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedJune 10, 2021
June 1, 2021
5 months
September 17, 2019
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 COMPARATORpreoperative interscalene nerve block to be applied with ultrasound guidance.
suprascapular and infraclavicular nerve block
ACTIVE COMPARATORpreoperative suprascapular and infraclavicular nerve block to be with ultrasound guidance
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.
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
Eligibility Criteria
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)
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