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cESPINas: Cervical Erector Spinae Block Versus Interscalene Block for Shoulder Surgery

Sponsor
Ataturk University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04435236
Collaborator
(none)
94
Enrollment
2
Arms
7
Anticipated Duration (Months)

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cervical ESP block
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
94 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Cervical Erector Spinae Plane Block Versus Interscalene Plexus Block for Pain Relief After Arthroscopic Shoulder Surgery: A Noninferiority Randomized Clinical Study
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Dec 30, 2021
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Cervical ESP block group

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

Procedure: Cervical ESP block
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
Other Names:
  • ISB Block

    		•
    Sham Comparator: ISB Block group

    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

    Procedure: Cervical ESP block
    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
    Other Names:
  • ISB Block

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Opioid consumption [24 hours postoperatively]

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

    Secondary Outcome Measures

    1. Postoperative pain scores [24 hours postoperatively]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ataturk University

    Investigators

    • Principal Investigator: İlker İnce, MD, Ataturk University Anesthesiology Clinical Research Office

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ilker Ince, Associated Prof. Dr. MD, Ataturk University
    ClinicalTrials.gov Identifier:
    NCT04435236
    Other Study ID Numbers:
    • B.30.2.ATA.0.01.00/142
    First Posted:
    Jun 17, 2020
    Last Update Posted:
    Jun 22, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Acute Pain

    Study Results

    No Results Posted as of Jun 22, 2021