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Completed

NCT Number: NCT02486549

Supraclavicular Versus Interscalene Block for Shoulder Surgery

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpasa University Medical School

Tokat Province, 60100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supraclavicular block

Procedure

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

interscalene block

Procedure

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

Bupivacaine

Drug

20ml 0.25% bupivacaine will be injected for brachial plexus block

Other names: Marcaine

Ultrasound

Device

The Ultrasound will be used for brachial plexus visualization

Primary outcomes

  1. Postoperative Pain

    Time frame: up to postoperative 24 hours

    The visual analog scale will be used for assessment

Secondary outcomes

  1. Quality of recovery

    Time frame: in the postoperative 24 hours

    The Quality of Recovery-40 (QR40) questionnaire will be used for assessment

  2. 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

  3. Sensory block

    Time frame: up to postoperative 24 hours

    The sensorial block will be assessed by pinprick test.

  4. Adverse events

    Time frame: up to postoperative 24 hours

    The number of patients with adverse events will be recorded.

  5. Analgesics requirement time

    Time frame: up to postoperative 24 hours

    the first intravenous analgesic requirement time will be recorded.

  6. 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.

  7. Heart rate changes

    Time frame: at time of surgery

    The heart rate will be assessed via electrocardiographic monitoring and recorded as beat/minute.

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 1, 2015
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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