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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tokat Gaziosmanpasa University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • artroscopy

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