Pain Management in Arthtroscopic Shoulder Surgery (PMSS)

June 7, 2021 updated by: Tugba Arslan, Diskapi Yildirim Beyazit Education and Research Hospital

Comparison of the Effects Combined Suprascapular and Infraclavicular Nerve Blocks to Interscalene Nerve Block Applied Arthtroscopic Shoulder Surgery

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, the investigators planned to investigate postoperative pain, analgesic dosage, respiratory effects of the block and side effects of patients undergoing general anaesthesia after arthroscopic shoulder surgery under preoperative interscalene nerve block or suprascapular + infraclavicular nerve block.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Diskapi Yildiim Beyazit Eduation and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Interscalene nerve block
preoperative interscalene nerve block to be applied with ultrasound guidance.
Other: Interscalene block
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.
Active Comparator: suprascapular and infraclavicular nerve block
preoperative suprascapular and infraclavicular nerve block to be with ultrasound guidance
Other: suprascapular and infraclavicular 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain: numeric rating scale (NRS)
Time Frame: postoperative 30. minute, 4. hour, 8.hour,12. hour, 24. hour, 48. hour
postoperative pain will be evaluated by numeric rating scale (NRS) .
postoperative 30. minute, 4. hour, 8.hour,12. hour, 24. hour, 48. hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
phrenic nerve paralysis evaluated with ultrasound
Time Frame: thirty minutes after the nerve block
Thirty minutes after the block, M-mode ultrasound examination of the ipsilateral hemidiaphragm was performed to measure diaphragmatic excursion.
thirty minutes after the nerve block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2019

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

September 17, 2019

First Submitted That Met QC Criteria

September 23, 2019

First Posted (Actual)

September 24, 2019

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 59/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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