NCT04083274

Ultrasound-Guided Erector Spinae Plane Block Following Upper Extremity Surgery

Efficacy of Ultrasound-Guided Erector Spinae Plane Block for Pain Management Following Upper Extremity Surgery

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medipol University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Upper Extremity Problem

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2019-10-22
• Primary completion: 2021-11-30
• Completion: 2021-12-30
• First posted: 2019-09-10
• Last updated: 2022-01-20

Locations

1 site across 1 country: Turkey (Türkiye)