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Cervical Erector Spinae Block Versus Interscalene Block for Shoulder Surgery (cESPINas)

Primary Purpose

Pain, Acute, Opioid Use

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cervical ESP block
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute

Eligibility Criteria

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

Inclusion Criteria:

  1. Age between 18-80
  2. ASA I-III
  3. Eligible for regional anesthesia
  4. Unilateral shoulder surgery

Exclusion Criteria:

  1. The patients who have clotting disorder
  2. Contra-endication for regional anesthesia
  3. Infection on the injection site
  4. Chronic opioid usage
  5. Previous same side shoulder surgery
  6. Severe COPD
  7. Diaphragmatic paralysis
  8. BMI 35 or over

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Cervical ESP block group

    ISB Block group

    Arm Description

    Cervical ESP block will be performed as described by Elsharkawy at al. (7).

    ISB block will be performed in transverse orientation of the ultrasound probe to visualize the trunks of the brachial plexus between the anterior and middle scalene muscles

    Outcomes

    Primary Outcome Measures

    Opioid consumption
    Iv Patient-controlled analgesia (PCA) with fentanyl (10mcg/cc concentration) will be started for all patients

    Secondary Outcome Measures

    Postoperative pain scores
    A Numeric Rating Scale (0 to 10 point scale) wiil be used for pain evaluation.

    Full Information

    First Posted
    June 12, 2020
    Last Updated
    June 20, 2021
    Sponsor
    Ataturk University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04435236
    Brief Title
    Cervical Erector Spinae Block Versus Interscalene Block for Shoulder Surgery
    Acronym
    cESPINas
    Official Title
    Cervical Erector Spinae Plane Block Versus Interscalene Plexus Block for Pain Relief After Arthroscopic Shoulder Surgery: A Noninferiority Randomized Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2021 (Anticipated)
    Primary Completion Date
    December 30, 2021 (Anticipated)
    Study Completion Date
    May 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ataturk University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Severe pain after arthroscopic surgery is a common experience for the patients . Different regional anesthetic technique has been applicated for postoperative pain relief . The main goal of regional anesthesia regarding postoperative pain relief is to reduce opioid requirements. The most commonly used approach is Interscalene brachial plexus block (ISB), since it provides effective postoperative analgesia upto 12 hours. Erector spinae plane block (ESPB) has been reported for a variety of indications such as thoracic and abdominal surgery. Recently, a novel description of a T2-3 erector spinae plane (ESP) as an alternative to a BP block for an upper extremity surgical procedure. Following these studies, direct cervical ESP block has been recently performed successfully as both clinical and cadaveric study. The investigators hypothesized that cervical ESP block is as effective as (non-inferior) interscalene brachial plexus block in terms of postoperative analgesia of shoulder surgery. To evaluate the effectiveness of the cervical ESP block, the investigators have designed a randomized study. Primary aim is to evaluate the postoperative opioid consumption. Secondary aim is to evaluate postoperative pain scores by Numeric Rating Scale (0 to 10 point scale).
    Detailed Description
    This study has been designed as a prospective, randomized and single-blind trial. Local ethics committee of Ataturk University has approved the study (B.30.2.ATA.0.01.00/142). After obtaining the patients' written informed consents, we will include a total number of 94 patients (47 patients for each group). The inclusion criteria of the study was considered as age between 18-80, American Society of Anesthesiologists (ASA) status I-III, eligible for regional anesthesia, and unilateral shoulder surgery. The patients who have clotting disorder, contra-indication for regional anesthesia, infection on the injection site, chronic opioid usage, previous same side shoulder surgery, severe Chronic obstructive pulmonary disease (COPD) , diaphragmatic paralysis, BMI 35 or over will be excluded. A computer-generated randomization program will be used to allocate the patient into two groups. Interscalene brachial plexus block group will be named as Group ISB (n=47) and cervical ESP block group will be named as Group cESP (n=47). The assessor of the outcomes will be blinded to the study groups of the patients. Both ISB block and cervical ESP block will be performed under ultrasound guidance in the block room preoperatively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Acute, Opioid Use

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    94 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cervical ESP block group
    Arm Type
    Active Comparator
    Arm Description
    Cervical ESP block will be performed as described by Elsharkawy at al. (7).
    Arm Title
    ISB Block group
    Arm Type
    Sham Comparator
    Arm Description
    ISB block will be performed in transverse orientation of the ultrasound probe to visualize the trunks of the brachial plexus between the anterior and middle scalene muscles
    Intervention Type
    Procedure
    Intervention Name(s)
    Cervical ESP block
    Other Intervention Name(s)
    ISB Block
    Intervention Description
    Cervical ESP block will be performed as described by Elsharkawy at al. (7). ISB block will be performed in transverse orientation of the ultrasound probe to visualize the trunks of the brachial plexus between the anterior and middle scalene muscles
    Primary Outcome Measure Information:
    Title
    Opioid consumption
    Description
    Iv Patient-controlled analgesia (PCA) with fentanyl (10mcg/cc concentration) will be started for all patients
    Time Frame
    24 hours postoperatively
    Secondary Outcome Measure Information:
    Title
    Postoperative pain scores
    Description
    A Numeric Rating Scale (0 to 10 point scale) wiil be used for pain evaluation.
    Time Frame
    24 hours postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 18-80 ASA I-III Eligible for regional anesthesia Unilateral shoulder surgery Exclusion Criteria: The patients who have clotting disorder Contra-endication for regional anesthesia Infection on the injection site Chronic opioid usage Previous same side shoulder surgery Severe COPD Diaphragmatic paralysis BMI 35 or over
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    İlker İnce, MD
    Phone
    +905052949840
    Email
    ilkerince1983@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mehmet Aksoy, MD
    Email
    drmaksoy@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    İlker İnce, MD
    Organizational Affiliation
    Ataturk University Anesthesiology Clinical Research Office
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Undecided
    Citations:
    PubMed Identifier
    20565394
    Citation
    Fredrickson MJ, Krishnan S, Chen CY. Postoperative analgesia for shoulder surgery: a critical appraisal and review of current techniques. Anaesthesia. 2010 Jun;65(6):608-624. doi: 10.1111/j.1365-2044.2009.06231.x.
    Results Reference
    background
    PubMed Identifier
    30966835
    Citation
    Demir U, Ince I, Aksoy M, Dostbil A, Ari MA, Sulak MM, Kose M, Tanios M, Ozmen O. The Effect of Pre-emptive Dexketoprofen Administration on Postoperative Pain Management in Patients with Ultrasound Guided Interscalene Block in Arthroscopic Shoulder Surgery. J Invest Surg. 2021 Jan;34(1):82-88. doi: 10.1080/08941939.2019.1576809. Epub 2019 Apr 9.
    Results Reference
    background
    PubMed Identifier
    9174311
    Citation
    Ritchie ED, Tong D, Chung F, Norris AM, Miniaci A, Vairavanathan SD. Suprascapular nerve block for postoperative pain relief in arthroscopic shoulder surgery: a new modality? Anesth Analg. 1997 Jun;84(6):1306-12. doi: 10.1097/00000539-199706000-00024.
    Results Reference
    background
    PubMed Identifier
    32044802
    Citation
    Abdallah FW, Wijeysundera DN, Laupacis A, Brull R, Mocon A, Hussain N, Thorpe KE, Chan VWS. Subomohyoid Anterior Suprascapular Block versus Interscalene Block for Arthroscopic Shoulder Surgery: A Multicenter Randomized Trial. Anesthesiology. 2020 Apr;132(4):839-853. doi: 10.1097/ALN.0000000000003132. Erratum In: Anesthesiology. 2020 Apr 3;:null.
    Results Reference
    background
    PubMed Identifier
    29868941
    Citation
    Tsui BCH, Mohler D, Caruso TJ, Horn JL. Cervical erector spinae plane block catheter using a thoracic approach: an alternative to brachial plexus blockade for forequarter amputation. Can J Anaesth. 2019 Jan;66(1):119-120. doi: 10.1007/s12630-018-1170-7. Epub 2018 Jun 4. No abstract available.
    Results Reference
    background
    PubMed Identifier
    31161549
    Citation
    Hamadnalla H, Elsharkawy H, Shimada T, Maheshwari K, Esa WAS, Tsui BCH. Cervical erector spinae plane block catheter for shoulder disarticulation surgery. Can J Anaesth. 2019 Sep;66(9):1129-1131. doi: 10.1007/s12630-019-01421-9. Epub 2019 Jun 3. No abstract available.
    Results Reference
    background
    PubMed Identifier
    32321860
    Citation
    Elsharkawy H, Ince I, Hamadnalla H, Drake RL, Tsui BCH. Cervical erector spinae plane block: a cadaver study. Reg Anesth Pain Med. 2020 Jul;45(7):552-556. doi: 10.1136/rapm-2019-101154. Epub 2020 Apr 21.
    Results Reference
    background

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    Cervical Erector Spinae Block Versus Interscalene Block for Shoulder Surgery

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