Erector Spinae Plane Block Versus Perioperative Intravenous Lidocaine for Thoracotomy

NCT ID: NCT04221880

Last Updated: 2022-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-29

Study Completion Date

2022-03-15

Brief Summary

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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.

Detailed Description

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Conditions

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Thoracic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Bupivacaine Hcl 0.25% Inj

Intervention Type DRUG

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

Saline Solution intravenously

Intervention Type DRUG

Same volume saline solution bolus and infusion as Group Lidocaine

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

Group Type ACTIVE_COMPARATOR

Saline Solution for Block

Intervention Type DRUG

Ultrasound-guided erector spinae plane block with 20 ml saline

Lidocaine

Intervention Type DRUG

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

Group Control

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

Group Type SHAM_COMPARATOR

Saline Solution for Block

Intervention Type DRUG

Ultrasound-guided erector spinae plane block with 20 ml saline

Saline Solution intravenously

Intervention Type DRUG

Same volume saline solution bolus and infusion as Group Lidocaine

Interventions

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Bupivacaine Hcl 0.25% Inj

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

Intervention Type DRUG

Saline Solution for Block

Ultrasound-guided erector spinae plane block with 20 ml saline

Intervention Type DRUG

Saline Solution intravenously

Same volume saline solution bolus and infusion as Group Lidocaine

Intervention Type DRUG

Lidocaine

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Ahmet Murat Yayik

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ataturk University

Erzurum, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 28919152 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30921979 (View on PubMed)

Other Identifiers

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ESP vs Lidocaine

Identifier Type: -

Identifier Source: org_study_id

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