Ultrasound-Guided Erector Spinae Plane Block or Interscalen Brachial Plexus Block Following Arthroscopic Shoulder Surgery

Shoulder Syndrome Clinical Trial

Official title:

Comparison of Ultrasound-Guided Erector Spinae Plane Block and Interscalen Brachial Plexus Block for Pain Management Following Arthroscopic Shoulder Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04083287
• Other study ID #: Medipol Hospital 5
• Status: Completed
• Phase: N/A
• Start date: April 26, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: April 2022
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative pain is important following arthroscopic shoulder surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay.Ultrasound (US)-guided brachial plexus blocks such as interscalen and supraclavicular block are usually performed. Interscalen brachial plexus block (ISCB) is one of the most preferred techniques among these.

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 compare the efficacy of the US-guided ESPB and ISCB for postoperative analgesia management after arthroscopic shoulder surgery.

Description:

Postoperative pain is an important issue in patients underwent arthroscopic shoulder 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 and supraclavicular block are commonly used. Interscalen brachial plexus block (ISCB) is one of the most preferred techniques among these.

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 compare the efficacy of the US-guided ESPB and ISCB for postoperative analgesia management after arthroscopic shoulder 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) classification I-II

• Scheduled for arthroscopic shoulder 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

Related Conditions & MeSH terms

• Shoulder Syndrome

Intervention

Other:
• Erector spinae plane block (Group E)
Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. 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.
• Interscalen brachial plexus block (Group I)
Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. 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.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University Hospital	Istanbul	Bagcilar

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Forero M, Rajarathinam M, Adhikary SD, Chin KJ. Erector spinae plane block for the management of chronic shoulder pain: a case report. Can J Anaesth. 2018 Mar;65(3):288-293. doi: 10.1007/s12630-017-1010-1. Epub 2017 Nov 13. — View Citation

Selvi O, Tulgar S, Ozer Z. Case Report Presentation of Ultrasound-guided Erector Spinae Plane Block in Shoulder Surgery: Three Patients and Two Different Results. Cureus. 2018 Nov 3;10(11):e3538. doi: 10.7759/cureus.3538. — View Citation

Wiegel M, Moriggl B, Schwarzkopf P, Petroff D, Reske AW. Anterior Suprascapular Nerve Block Versus Interscalene Brachial Plexus Block for Shoulder Surgery in the Outpatient Setting: A Randomized Controlled Patient- and Assessor-Blinded Trial. Reg Anesth Pain Med. 2017 May/Jun;42(3):310-318. doi: 10.1097/AAP.0000000000000573. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	The primary aim is to compare perioperative and postoperative opioid consumption	Change from baseline opioid consumption at postoperative 1, 2, 4, 8, 16, 24 and 48 hours
Secondary	Pain scores (Visual analogue scores-VAS)	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	Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, 24 and 48 hours.