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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04221880
Other study ID # ESP vs Lidocaine
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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