Cervical Erector Spinae Block Versus Interscalene Block for Shoulder Surgery

NCT04435236 | Unknown

• 1 other identifier: B.30.2.ATA.0.01.00/142
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pain, Acute; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

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

  24 hours postoperatively

Secondary Outcomes (1)

• Postoperative pain scores

  24 hours postoperatively

Study Arms (2)

Cervical ESP block group

ACTIVE COMPARATOR

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

Procedure: Cervical ESP block

ISB Block group

SHAM COMPARATOR

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

Interventions

Cervical ESP block PROCEDURE

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

Also known as: ISB Block

Cervical ESP block group; ISB Block group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-80
• ASA I-III
• Eligible for regional anesthesia
• Unilateral shoulder surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Related Publications (7)

• 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.

  PMID: 20565394 BACKGROUND

• 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.

  PMID: 30966835 BACKGROUND

• 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.

  PMID: 9174311 BACKGROUND

• 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.

  PMID: 32044802 BACKGROUND

• 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.

  PMID: 29868941 BACKGROUND

• 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.

  PMID: 31161549 BACKGROUND

• 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.

  PMID: 32321860 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• İlker İnce, MD

  Ataturk University Anesthesiology Clinical Research Office

  PRINCIPAL INVESTIGATOR

Central Study Contacts

İlker İnce, MD

CONTACT

+905052949840; ilkerince1983@yahoo.com

Mehmet Aksoy, MD

CONTACT

drmaksoy@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Prof. Dr. MD

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 17, 2020
• Study Start: October 1, 2021
• Primary Completion: December 30, 2021
• Study Completion: May 1, 2022
• Last Updated: June 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share