Erector Spinae Plane Block Versus Perioperative Intravenous Lidocaine for Thoracotomy

Thoracic Diseases Clinical Trial

Official title:

Erector Spinae Plane Block Versus Perioperative Intravenous Lidocaine for Postoperative Pain Control in Patients Undergoing Thoracotomy: A Prospective, Randomized, Double-blind Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04221880
• Other study ID #: ESP vs Lidocaine
• Status: Completed
• Phase: N/A
• Start date: September 29, 2021
• Est. completion date: March 15, 2022

Study information

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

Clinical Trial Summary

Thoracotomy surgery is the most painful of all surgical procedures. Inadequate postoperative pain control in these patients may cause serious morbidity related to pulmonary, cardiovascular and emotional systems. Erector Spinae Plane Block (ESPB) was first described in 2016 and, it is frequently used for postoperative analgesia in thoracic surgery. Intravenous lidocaine exhibit analgesic activity through both the peripheral and central nervous system. Intravenous lidocaine has been shown to reduce postoperative pain intensity and accelerate postoperative recovery in many surgeries. The investigators aimed to compare the effect of lidocaine infusion and erector spinae plane block on postoperative opioid consumption and pain scores.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 15, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologist's physiologic state I-III patients undergoing thoracotomy surgery

Exclusion Criteria:

• chronic pain, bleeding disorders, renal or hepatic insufficiency, non cooperative patient,
• Patients with allergies to one of the drugs used in the study.

Related Conditions & MeSH terms

• Thoracic Diseases

Intervention

Drug:
• Bupivacaine Hcl 0.25% Inj
Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine
• Saline Solution for Block
Ultrasound-guided erector spinae plane block with 20 ml saline
• Saline Solution intravenously
Same volume saline solution bolus and infusion as Group Lidocaine
• Lidocaine
1.5 mg / kg lidocaine iv. bolus and, 1.5mg / kg / h lidocaine iv. infusion

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12. — View Citation

Moeen SM, Moeen AM. Usage of Intravenous Lidocaine Infusion with Enhanced Recovery Pathway in Patients Scheduled for Open Radical Cystectomy: A Randomized Trial. Pain Physician. 2019 Mar;22(2):E71-E80. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Consumption	First 24 hours total fentanyl consumption with patient controlled analgesia	First 24 hours total opioid consumption
Secondary	Visual analog pain score	Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively.	Postoperative 24 hour