Ultrasound-Guided Erector Spinae Plane Block Following Upper Extremity Surgery

NCT04083274 | Withdrawn

• 1 other identifier: Medipol Hospital 4
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Extremity Problem

Keywords

Upper extremity surgery; Postoperative pain management; Erector spina plane block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain scores (Visual analogue scores-VAS)

  Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16, 24 and 48 hours.

Study Arms (2)

Group E = ESPB group

ACTIVE COMPARATOR

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)

Group S = Sham block group

SHAM COMPARATOR

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)

Interventions

Erector spinae plane block (Group E) OTHER

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.

Group E = ESPB group

Sham block group (Group S) OTHER

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

Group S = Sham block group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related 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.

  PMID: 29134518 BACKGROUND

• 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.

  PMID: 30648071 BACKGROUND

• 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.

  PMID: 28257388 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient, the investigator and the anesthesiologist who performs postoperative pain evaluation will not know the group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary researcher

Model Details: There are two models for this study. The first group is erector spinae plane block group. The second one is sham block group

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: September 10, 2019
• Study Start: October 22, 2019
• Primary Completion: November 30, 2021
• Study Completion: December 30, 2021
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)