Supraclavicular Versus Interscalene Block for Shoulder Surgery

February 20, 2017 updated by: Tuğba Karaman, Tokat Gaziosmanpasa University

A Prospective Randomized Comparison of Ultrasound-guided Supraclavicular and Interscalene Block in Patients Undergoing Arthroscopic Shoulder Surgery

The purpose of this study is to compare the supraclavicular block to interscalene block in patients undergoing arthroscopic shoulder surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to evaluate the efficacy of the supraclavicular block in comparison with interscalene block on postoperative pain, quality of recovery and side effects in patients undergoing arthroscopic shoulder surgery under general anesthesia.

Study Type

Interventional

Enrollment (Actual)

62

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
      • Tokat, Turkey, 60100
        • Gaziosmanpasa University Medical School

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing shoulder surgery in American Society of Anesthesiologists physical status I-II

Exclusion Criteria:

  • with a known allergy to study medications,
  • chronic opioid use,
  • ipsilateral upper limb neurological deficits,
  • severe respiratory disease,
  • coagulopathy

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supraclavicular Block
Ultrasound guided supraclavicular block with 20 ml of 0.25% bupivacaine will be performed
Procedure: Supraclavicular Block
Under ultrasound guidance an insulated needle is advanced with in- plane technique into the brachial plexus sheath and 20ml 0.25% bupivacaine will be administered
Drug: Bupivacaine
20ml 0.25% bupivacaine will be injected for brachial plexus block
Other Names:
  • Marcaine
Device: Ultrasound
The Ultrasound will be used for brachial plexus visualization
Active Comparator: Interscalene block
Ultrasound guided inter scalene block with 20ml of 0.25% bupivacaine will be performed.
Drug: Bupivacaine
20ml 0.25% bupivacaine will be injected for brachial plexus block
Other Names:
  • Marcaine
Device: Ultrasound
The Ultrasound will be used for brachial plexus visualization
Procedure: Interscalene Block
Under ultrasound guidance an insulated needle will be placed through the middle scalene muscle,into the interscalene groove with in-plane technique and 20ml 0.25%bupivacaine will be administered into the brachial plexus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain
Time Frame: up to postoperative 24 hours
The visual analog scale will be used for assessment
up to postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of recovery
Time Frame: in the postoperative 24 hours
The Quality of Recovery-40 (QR40) questionnaire will be used for assessment
in the postoperative 24 hours
Motor block
Time Frame: up to postoperative 24 hours
The muscle force will be evaluated with scale 0 to 3( 0:normal muscle force, 1: reduced muscle force, 2: impaired mobility 3: paralysis
up to postoperative 24 hours
Sensory block
Time Frame: up to postoperative 24 hours
The sensorial block will be assessed by pinprick test.
up to postoperative 24 hours
Adverse events
Time Frame: up to postoperative 24 hours
The number of patients with adverse events will be recorded.
up to postoperative 24 hours
Analgesics requirement time
Time Frame: up to postoperative 24 hours
the first intravenous analgesic requirement time will be recorded.
up to postoperative 24 hours
Systolic Blood pressure changes
Time Frame: at time of surgery
The blood pressure will be measured non invasively and the systolic blood pressure lower than 90 mmHg or decrease more than 20% of baseline will be accepted as a hypotension.
at time of surgery
Heart rate changes
Time Frame: at time of surgery
The heart rate will be assessed via electrocardiographic monitoring and recorded as beat/minute.
at time of surgery

Collaborators and Investigators

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

Sponsor

Tokat Gaziosmanpasa University

Investigators

  • Principal Investigator: Tugba Karamanaraman, M.D., Gaziosmanpasa University Medical School

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)

June 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

June 26, 2015

First Posted (Estimate)

July 1, 2015

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • artroscopy

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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