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Interscalene Brachial Plexus Block Combined With Suprascapular Nerve Block

Primary Purpose

Rotator Cuff Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound-guided ISB
Arthroscopy-guided SSNB
Placebo
Ropivacaine
Sponsored by
Chuncheon Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rotator Cuff Injury focused on measuring sono-guided interscalene brachial plexus block, arthroscopy-guided suprascapular nerve block, arthroscopic rotator cuff repair, postoperative pain

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. definite rotator cuff tear on preoperative MRI, which needed repair;
  2. acceptance of arthroscopic surgery including rotator cuff repair;
  3. > 20 years old; and
  4. acceptance of routine regional blocks and patient-controlled analgesia.

Exclusion Criteria:

  1. did not want arthroscopic rotator cuff repair;
  2. stopped PCA before 48 h postoperatively due to side effects;
  3. history of shoulder operation or fracture;
  4. concomitant neurological disorder around the shoulder;
  5. conversion to open surgery from the arthroscopy; and
  6. contraindication to the routine regional blocks in this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    ISB with SSNB

    ISB alone

    Arm Description

    During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL ropivacaine.

    During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL normal saline.

    Outcomes

    Primary Outcome Measures

    Visual Analog Scale (VAS) Pain Score
    The VAS pain score was based on a scale from 0 to 10, where 0 indicated no pain and 10 indicated severe pain

    Secondary Outcome Measures

    Patient Satisfaction (SAT) Score
    The SAT score was also from 0 to 10, where 0 indicated unsatisfactory and 10 indicated very satisfactory.

    Full Information

    First Posted
    April 17, 2015
    Last Updated
    August 25, 2020
    Sponsor
    Chuncheon Sacred Heart Hospital
    Collaborators
    Hallym University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02424630
    Brief Title
    Interscalene Brachial Plexus Block Combined With Suprascapular Nerve Block
    Official Title
    The Effect of Sono-Guided Interscalene Brachial Plexus Block Combined With Arthroscopy-Guided Suprascapular Nerve Block in Arthroscopic Rotator Cuff Repair: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2013 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chuncheon Sacred Heart Hospital
    Collaborators
    Hallym University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The investigators compared the results of sono-guided interscalene brachial plexus block (ISB) combined with arthroscopy-guided suprascapular nerve block (SSNB) with those of ISB alone within the first 48 h after arthroscopic rotator cuff repair.
    Detailed Description
    Forty-eight patients with rotator cuff tears who had undergone arthroscopic rotator cuff repair were enrolled. The 24 patients randomly allocated to group 1 received ISB and SSNB; the remaining 24 patients in group 2 underwent ISB alone. VAS pain score, patient's satisfaction (SAT) were checked postoperative 1, 3, 6, 12, 18, 24, 36, and 48 hours. VAS pain score was selected from 0 to 10 was no pain and 10 was severe pain that the patient had ever experienced. SAT was also selected from 0 to 10 was unsatisfactory and 10 was very satisfactory. Rebound of postoperative pain was confirmed if there had been an increase of VAS pain score after postoperative 1 hour.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotator Cuff Injury
    Keywords
    sono-guided interscalene brachial plexus block, arthroscopy-guided suprascapular nerve block, arthroscopic rotator cuff repair, postoperative pain

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ISB with SSNB
    Arm Type
    Experimental
    Arm Description
    During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL ropivacaine.
    Arm Title
    ISB alone
    Arm Type
    Placebo Comparator
    Arm Description
    During arthroscopic rotator cuff repair, ultrasound-guided ISB was performed preemptively with 7.5 mL ropivacaine immediately after general anesthesia was induced. And at the end of surgery, arthroscopy-guided SSNB was performed with 10 mL normal saline.
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasound-guided ISB
    Intervention Description
    ISB was performed by one anesthesiologist under ultrasound-guidance. The superior, middle, and inferior trunks of the brachial plexus were identified approximately 2 cm above the clavicle. A 50 mm 22-gauge needle was introduced percutaneously using an out-of-plane technique. The needle was placed beside each trunk in succession, and 2.5 mL ropivacaine was injected into each site. The total volume of ropivacaine used for ISB was 7.5 mL.
    Intervention Type
    Device
    Intervention Name(s)
    Arthroscopy-guided SSNB
    Intervention Description
    At the end of the surgery, SSNB was performed under arthroscopic guidance by one shoulder arthroscopist. The suprascapular ligament was found using the lateral portal for visualization. The supraclavicular ligament was visualized at the end of the conoid ligament when the arthroscope was advanced following the coracoclavicular ligament. A 23-gauge spinal needle was introduced in a posteroanterior direction at a 20° angle percutaneously and 7 cm medial to the lateral margin of the acromion. Then, the needle was placed at the upper margin of the suprascapular ligament and advanced slightly under arthroscopy-guidance. After suctioning the saline from the portal, the injection material was administered according to the random assignment.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    All the regional blocks in this study were performed using ropivacaine, except for arthroscopy-guided SSNB using placebo (10 mL normal saline)
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine
    Intervention Description
    All the regional blocks in this study were performed using 10mL ropivacaine.
    Primary Outcome Measure Information:
    Title
    Visual Analog Scale (VAS) Pain Score
    Description
    The VAS pain score was based on a scale from 0 to 10, where 0 indicated no pain and 10 indicated severe pain
    Time Frame
    1, 3, 6, 12, 18, 24, 36, 48h
    Secondary Outcome Measure Information:
    Title
    Patient Satisfaction (SAT) Score
    Description
    The SAT score was also from 0 to 10, where 0 indicated unsatisfactory and 10 indicated very satisfactory.
    Time Frame
    1, 3, 6, 12, 18, 24, 36, 48h

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: definite rotator cuff tear on preoperative MRI, which needed repair; acceptance of arthroscopic surgery including rotator cuff repair; > 20 years old; and acceptance of routine regional blocks and patient-controlled analgesia. Exclusion Criteria: did not want arthroscopic rotator cuff repair; stopped PCA before 48 h postoperatively due to side effects; history of shoulder operation or fracture; concomitant neurological disorder around the shoulder; conversion to open surgery from the arthroscopy; and contraindication to the routine regional blocks in this study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jung-Taek Hwang, MD, PhD
    Organizational Affiliation
    Chuncheon Sacred Heart Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27311449
    Citation
    Lee JJ, Hwang JT, Kim DY, Lee SS, Hwang SM, Lee NR, Kwak BC. Effects of arthroscopy-guided suprascapular nerve block combined with ultrasound-guided interscalene brachial plexus block for arthroscopic rotator cuff repair: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Jul;25(7):2121-2128. doi: 10.1007/s00167-016-4198-7. Epub 2016 Jun 16.
    Results Reference
    derived

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    Interscalene Brachial Plexus Block Combined With Suprascapular Nerve Block

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