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Erector Spinae Plane Block Versus Perioperative Intravenous Lidocaine for Thoracotomy

Primary Purpose

Thoracic Diseases

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Bupivacaine Hcl 0.25% Inj

Saline Solution for Block

Saline Solution intravenously

Lidocaine

About this trial

This is an interventional treatment trial for Thoracic Diseases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Arm Label

Group ESPB

Group Lidocaine

Group Control

Arm Description

Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine and Saline iv. bolus and infusion (same volume as 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

Ultrasound-guided erector spinae plane block with 20 ml saline and, Saline iv. bolus and infusion (same volume as Group Lidocaine)

Outcomes

Primary Outcome Measures

Opioid Consumption

First 24 hours total fentanyl consumption with patient controlled analgesia

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04221880

First Posted

January 7, 2020

Last Updated

May 13, 2022

Sponsor

Ataturk University

1. Study Identification

Unique Protocol Identification Number

NCT04221880

Brief Title

Erector Spinae Plane Block Versus Perioperative Intravenous Lidocaine for Thoracotomy

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

September 29, 2021 (Actual)

Primary Completion Date

March 1, 2022 (Actual)

Study Completion Date

March 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thoracic Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group ESPB

Arm Type

Active Comparator

Arm Description

Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine and Saline iv. bolus and infusion (same volume as Group Lidocaine)

Arm Title

Group Lidocaine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group Control

Arm Type

Sham Comparator

Arm Description

Ultrasound-guided erector spinae plane block with 20 ml saline and, Saline iv. bolus and infusion (same volume as Group Lidocaine)

Intervention Type

Drug

Intervention Name(s)

Bupivacaine Hcl 0.25% Inj

Intervention Description

Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine

Intervention Type

Drug

Intervention Name(s)

Saline Solution for Block

Intervention Description

Ultrasound-guided erector spinae plane block with 20 ml saline

Intervention Type

Drug

Intervention Name(s)

Saline Solution intravenously

Intervention Description

Same volume saline solution bolus and infusion as Group Lidocaine

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Intervention Description

1.5 mg / kg lidocaine iv. bolus and, 1.5mg / kg / h lidocaine iv. infusion

Primary Outcome Measure Information:

Title

Opioid Consumption

Description

First 24 hours total fentanyl consumption with patient controlled analgesia

Time Frame

First 24 hours total opioid consumption

Secondary Outcome Measure Information:

Title

Visual analog pain score

Description

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.

Time Frame

Postoperative 24 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Ataturk University

City

Erzurum

Country

Turkey

12. IPD Sharing Statement

Citations:

PubMed Identifier

28919152

Citation

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.

Results Reference

background

PubMed Identifier

30921979

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.

Results Reference

background

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Erector Spinae Plane Block Versus Perioperative Intravenous Lidocaine for Thoracotomy

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