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Ultrasound-Guided Erector Spinae Plane Block Following Upper Extremity Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04083274
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Bahadir Ciftci, Medipol University

Brief Summary:

Postoperative pain is important following upper extremity surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay.Ultrasound (US)-guided brachial plexus blocks such as interscalen, axillary, infraclavicular and supraclavicular block are usually performed.

The US-guided erector spina plane block (ESPB) is a novel interfacial plan block defined by Forero et al. Local anesthetic injection is administrated into the deep fascia of erector spinae. ESPB provides thoracic analgesia at T5 level, abdominal analgesia at T7-9 level, and lumbar analgesia at T10-12, L3 levels. There are a few case reports about the efficacy of ESPB for acute and chronic shoulder pain. However, there are no randomized clinical studies. The aim of this study is to evaluate the efficacy of the US-guided ESPB for postoperative analgesia management after upper extremity surgery.


Condition or disease Intervention/treatment Phase
Upper Extremity Problem Other: Erector spinae plane block (Group E) Other: Sham block group (Group S) Not Applicable

Detailed Description:

Postoperative pain is an important issue in patients underwent upper extremity surgery. Pain causes a few problems; discomfortable patients, negative outcomes and longer rehabilitation. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization such as infection and thromboembolism may be reduced. Various techniques may be used for postoperative pain treatment. Opioids are one of the most preferred drugs among the analgesic agents. Parenteral opioids are generally performed for patients after surgery. However opioids have undesirable adverse events such as nausea, vomiting, itching, sedation and respiratory depression (opioid-related adverse events).

Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment following arthroscopic shoulder surgery. Ultrasound (US)-guided brachial plexus blocks such as interscalen, axillary, infraclavicular and supraclavicular block are commonly used.

US-guided interfascial plane blocks have been used increasily due to the advantages of ultrasound in anesthesia practice. The US-guided erector spina plane block (ESPB) is a novel interfacial plan block defined by Forero et al. at 2016. The ESPB contains a local anesthetic injection into the deep fascia of erector spinae. This area is away from the pleural and neurological structures and thus minimizes the risk of complications due to injury. Visualization of sonoanatomy with US is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. Cadaveric studies have shown that the injection spreads to the ventral and dorsal roots of the spinal nerves. ESPB provides thoracic analgesia at T5 level, abdominal analgesia at T7-9 level, and lumbar analgesia at T10-12, L3 levels. To the best of our knowledge, there have been a few case reports about the efficacy of ESPB for acute and chronic shoulder pain. There are no randomized clinical studies, yet.

The aim of this study is to evaluate the efficacy of the US-guided ESPB for postoperative analgesia management after underwent upper extremity surgery. The primary aim is to compare perioperative and postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: There are two models for this study. The first group is erector spinae plane block group. The second one is sham block group
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The patient, the investigator and the anesthesiologist who performs postoperative pain evaluation will not know the group.
Primary Purpose: Treatment
Official Title: Efficacy of Ultrasound-Guided Erector Spinae Plane Block for Pain Management Following Upper Extremity Surgery
Actual Study Start Date : October 22, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Arm Intervention/treatment
Active Comparator: Group E = ESPB group
In group E, ESPB will be performed. US probe will be placed longitudinally 2-3 cm lateral to the T2 transvers process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle will be inserted caudo-cranial direction and then for correction of the needle 5 ml saline will be enjected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 30 ml %0.25 bupivacaine will be administered for block.
Other: Erector spinae plane block (Group E)

Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.

Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 1, 2, 4, 8, 16, 24 and 48 hours. If the VAS score will be ≥ 4, 0.5 mg/ kg meperidine IV will be administered. Sedation level will be assessed with a 4-point sedation scale (0 = awake, eyes open, 1 = sleepy but responding to verbal stimulus, 2 = sleepy and hard to evoke, 3 = sleepy, not aroused by shaking). The first time of the use of rescue analgesic, intraoperative and postoperative opioid consumption, side effects such as nausea, vomiting, itching and block related complications will be recorded.


Sham Comparator: Group S = Sham block group
In group S, sham block will be performed. US probe will be placed longitudinally 2-3 cm lateral to the T2 transvers process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle will be inserted caudo-cranial direction and then for correction of the needle 5 ml saline will be enjected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 30 ml normal saline will be administered for block.
Other: Sham block group (Group S)

Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.

Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 1, 2, 4, 8, 16, 24 and 48 hours. If the VAS score will be ≥ 4, 0.5 mg/ kg meperidine IV will be administered. Sedation level will be assessed with a 4-point sedation scale (0 = awake, eyes open, 1 = sleepy but responding to verbal stimulus, 2 = sleepy and hard to evoke, 3 = sleepy, not aroused by shaking). The first time of the use of rescue analgesic, intraoperative and postoperative opioid consumption, side effects such as nausea, vomiting, itching and block related complications will be recorded





Primary Outcome Measures :
  1. Opioid consumption [ Time Frame: Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours ]
    The primary aim is to compare perioperative and postoperative opioid consumption


Secondary Outcome Measures :
  1. Pain scores (Visual analogue scores-VAS) [ Time Frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, 24 and 48 hours. ]
    Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for upper extremity surgery under general anesthesia

Exclusion Criteria:

  • history of bleeding diathesis,
  • receiving anticoagulant treatment,
  • known local anesthetics and opioid allergy,
  • infection of the skin at the site of the needle puncture,
  • pregnancy or lactation,
  • patients who do not accept the procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083274


Contacts
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Contact: Bahadir Ciftci +905325034428 bciftci@medipol.edu.tr
Contact: Mürsel Ekinci +905067137596 mekinci@medipol.edu.tr

Locations
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Turkey
Istanbul Medipol University Hospital Recruiting
Istanbul, Bagcilar, Turkey, 34070
Contact: Bahadir Ciftci, MD    +905325034428    bciftci@medipol.edu.tr   
Contact: Mürsel Ekinci, MD    +905067137596    drmurselekinci@gmail.com   
Sponsors and Collaborators
Medipol University
Publications:
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Responsible Party: Bahadir Ciftci, Primary researcher, Medipol University
ClinicalTrials.gov Identifier: NCT04083274    
Other Study ID Numbers: Medipol Hospital 4
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will not plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bahadir Ciftci, Medipol University:
Upper extremity surgery
Postoperative pain management
Erector spina plane block