Erector Spinae Plane Block Versus Perioperative Intravenous Lidocaine for Thoracotomy

May 13, 2022 updated by: Ahmet Murat Yayik, Ataturk University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzurum, Turkey
        • Ataturk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group ESPB
Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine and Saline iv. bolus and infusion (same volume as Group Lidocaine)
Drug: Bupivacaine Hcl 0.25% Inj
Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine
Drug: Saline Solution intravenously
Same volume saline solution bolus and infusion as Group Lidocaine
ACTIVE_COMPARATOR: Group Lidocaine
1.5 mg / kg lidocaine iv. bolus and, 1.5mg / kg / h lidocaine iv. infusion and, Ultrasound-guided erector spinae plane block with 20 ml saline
Drug: Saline Solution for Block
Ultrasound-guided erector spinae plane block with 20 ml saline
Drug: Lidocaine
1.5 mg / kg lidocaine iv. bolus and, 1.5mg / kg / h lidocaine iv. infusion
SHAM_COMPARATOR: Group Control
Ultrasound-guided erector spinae plane block with 20 ml saline and, Saline iv. bolus and infusion (same volume as Group Lidocaine)
Drug: Saline Solution intravenously
Same volume saline solution bolus and infusion as Group Lidocaine
Drug: Saline Solution for Block
Ultrasound-guided erector spinae plane block with 20 ml saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Consumption
Time Frame: First 24 hours total opioid consumption
First 24 hours total fentanyl consumption with patient controlled analgesia
First 24 hours total opioid consumption

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog pain score
Time Frame: Postoperative 24 hour
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 29, 2021

Primary Completion (ACTUAL)

March 1, 2022

Study Completion (ACTUAL)

March 15, 2022

Study Registration Dates

First Submitted

January 7, 2020

First Submitted That Met QC Criteria

January 7, 2020

First Posted (ACTUAL)

January 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 16, 2022

Last Update Submitted That Met QC Criteria

May 13, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESP vs Lidocaine

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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