Erector Spinae Plane Block and Thoracal Paravertebral Block Following Video Assisted Thoracic Surgery

NCT03854773 | Completed

• 1 other identifier: MedipolU
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours at postoperative period. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption. The ultrasound (US) guided erector spina plane (ESP) block is a novel interfacial plan block defined by Forero et al. at 2016. ESP block provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. Visualization of sonoanatomy with US is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle (12). Thus, analgesia occurs in several dermatomes with cephalad-caudad way. In the literature, there is not still any randomized study evaluating ESP block efficiency for postoperative analgesia management after VATS. The aim of this study is to compare US-guided ESP block and TPVB for postoperative analgesia management after VATS.

Conditions

Lung Diseases

Keywords

Erector spinae plane block; Video assisted thoracic surgery,; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• opioid consumption

  The primary aim is to compare perioperative and postoperative opioid consumption

  Change from Baseline Postoperative Visual Analogue Score at 48 hours

Secondary Outcomes (1)

• Visual analogue scores (VAS)

  postoperative 1, 2, 4, 8, 16, 24, and 48 hours

Study Arms (3)

Erector spinae block (Group ESPB)

ACTIVE COMPARATOR

In group A, ESP block will be performed. US probe will be placed longitudinally 2-3 cm lateral to the T5 transverse process. From superior to inferior, three muscles will be visualized on the hyperechoic transverse process; trapezius (upper), rhomboideus major (middle), erector spinae (lower). The block needle will be inserted cranio caudal direction and then for correction of the needle 5 ml saline will be injected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 20 ml %0.25 bupivacaine will be administered for block.

Other: Erector spinae plane block (Group ESPB)

Thoracal paravertebral block group (Group TPVB)

ACTIVE COMPARATOR

In group B, TPVB will be performed. US probe will be placed 2-3 cm laterally following the visualization T5 spinous process in sagittal orientation. The ribs and transverse processes will be visualized as hyperechoic structures. The costotransverse ligament will be visualized in the superior, and the pleura in the anterior region. Using in plane technique, the block needle will be inserted in the cranio-caudal direction until the costotransverse ligament will be passed. For confirmation of correct position of the needle, 5 ml saline will be injected. After the negative aspiration of cerebrospinal fluid, blood and air; 20 ml of 0.25% bupivacaine will be performed and it will be seen of moving downwards of the pleura during the injection

Other: Thoracal paravertebral block (Group TPVB)

Control group (Group C)

OTHER

Patients in control group will be only received fentanyl via a patient controlled analgesia (PCA) device.

Other: Control group (group C)

Interventions

Erector spinae plane block (Group ESPB) OTHER

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 patient evaluation will be performed by an anesthesiologist blinded to the procedure.

Erector spinae block (Group ESPB)

Thoracal paravertebral block (Group TPVB) OTHER

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 patient evaluation will be performed by an anesthesiologist blinded to the procedure.

Thoracal paravertebral block group (Group TPVB)

Control group (group C) OTHER

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 patient evaluation will be performed by an anesthesiologist blinded to the procedure.

Control group (Group C)

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 VATS 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, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• Forero M, Rajarathinam M, Adhikary S, Chin KJ. Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. A A Case Rep. 2017 May 15;8(10):254-256. doi: 10.1213/XAA.0000000000000478.

  PMID: 28252539 BACKGROUND

• Vogt A, Stieger DS, Theurillat C, Curatolo M. Single-injection thoracic paravertebral block for postoperative pain treatment after thoracoscopic surgery. Br J Anaesth. 2005 Dec;95(6):816-21. doi: 10.1093/bja/aei250. Epub 2005 Sep 30.

  PMID: 16199417 BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: the patient 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: Medical Doctor

Model Details: there are three models for this study. the first group is erector spinae plane block group. the second one is thoracal paravertebral block group. the third one is the control group.

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: February 26, 2019
• Study Start: March 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)