Erector Spinae Plane Block for Postoperative Analgesia Management Following Video Assisted Thoracic Surgery

NCT03879148 | Completed

• 1 other identifier: Medipol University Hospital
• Study Type: interventional
• Target: 60
• 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. 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 evaluate US-guided ESP block for postoperative analgesia management after VATS.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Postoperative opioid consumption change is being assessed

  All patients received fentanyl via a patient controlled analgesia (PCA) device.

  Postoperative 1, 2, 4, 8, 16 and 24 hours

Secondary Outcomes (1)

• Postoperative pain scores (Visual analoge score-VAS) is being assessed

  Postoperative 1, 2, 4, 8, 16 and 24 hours

Study Arms (2)

Erector spinae plane block (Group I)

ACTIVE COMPARATOR

The ultrasound (US) guided ESPB was performed under aseptic conditions at the level of T5 vertebrae using the GE Vivid Q® US device. A high frequency 12 MHz linear US probe was covered with a sterile sheath and placed longitudinally 2-3 cm lateral to the T5 transvers process. After visualizing trapezius, rhomboid major, erector spinae muscles superficial to the hyperechoic transverse process shadow respectively, a 22-gauge 50 mm block needle (Braun Stimuplex Ultra 360, Germany) was inserted in a cephalad to caudad direction. Once the needle tip had been placed within the interfacial plane below the erector spinae muscle, 2 mL of saline were injected to confirm the proper injection site, and then a 20 mL dose of 0.25% bupivacaine was injected. Patients received fentanyl via a patient controlled analgesia (PCA) device with a protocol of 2 mL (10 µg/mL) bolus without an infusion dose, 20 min lockout time and 4 hour limit

Other: Erector spinae plane block

Control group (Group II)

NO INTERVENTION

Patients in control group only received fentanyl via a patient controlled analgesia (PCA) device with a protocol of 2 mL (10 µg/mL) bolus without an infusion dose, 20 min lockout time and 4 hour limit.

Interventions

Erector spinae plane block OTHER

Erector spinae plane block was performed to the patients under aseptic conditions

Erector spinae plane block (Group I)

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of primary lung carcinoma
• Must be undergoing VATS lobectomy under general anesthesia
• Must be in American Society of Anesthesiologists (ASA) classification I-II status

You may not qualify if:

• History of bleeding diathesis,
• History of receiving anticoagulant treatment,
• History of local anesthetics or opioid allergy,
• Skin infection at the site of the needle puncture,
• Presence of pregnancy or lactation, and
• Patients who did 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

• Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.

  PMID: 29980005 BACKGROUND

• Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.

  PMID: 30052229 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Postoperative pain assessment was performed by a anesthetists blinded to the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized prospective study

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 18, 2019
• Study Start: September 1, 2018
• Primary Completion: April 28, 2019
• Study Completion: April 30, 2019
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)