Cervical Erector Spinae Block Versus Interscalene Block for Shoulder Surgery

Opioid Use Clinical Trial

— cESPINas  

Official title:

Cervical Erector Spinae Plane Block Versus Interscalene Plexus Block for Pain Relief After Arthroscopic Shoulder Surgery: A Noninferiority Randomized Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04435236
• Other study ID #: B.30.2.ATA.0.01.00/142
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: June 2021
• Source: Ataturk University
• Contact: Ilker Ince, MD
• Phone: +905052949840
• Email: ilkerince1983[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 94
• Est. completion date: May 1, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Opioid Use
• Pain, Acute

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

References & Publications (7)

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. — View 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. — View 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. — View 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):608-24. doi: 10.1111/j.1365-2044.2009.06231.x. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	Iv Patient-controlled analgesia (PCA) with fentanyl (10mcg/cc concentration) will be started for all patients	24 hours postoperatively
Secondary	Postoperative pain scores	A Numeric Rating Scale (0 to 10 point scale) wiil be used for pain evaluation.	24 hours postoperatively