NCT04221880

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
1.7 years until next milestone

Study Start

First participant enrolled

September 29, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

May 16, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

January 7, 2020

Last Update Submit

May 13, 2022

Conditions

Thoracic Diseases

Outcome Measures

Primary Outcomes (1)

  • Opioid Consumption

    First 24 hours total fentanyl consumption with patient controlled analgesia

    First 24 hours total opioid consumption

Secondary Outcomes (1)

  • Visual analog pain score

    Postoperative 24 hour

Study Arms (3)

Group ESPB

ACTIVE COMPARATOR

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% InjDrug: Saline Solution intravenously

Group Lidocaine

ACTIVE COMPARATOR

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 BlockDrug: Lidocaine

Group Control

SHAM COMPARATOR

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

Drug: Saline Solution for BlockDrug: Saline Solution intravenously

Interventions

Bupivacaine Hcl 0.25% InjDRUG

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

Group ESPB
Saline Solution for BlockDRUG

Ultrasound-guided erector spinae plane block with 20 ml saline

Group ControlGroup Lidocaine
Saline Solution intravenouslyDRUG

Same volume saline solution bolus and infusion as Group Lidocaine

Group ControlGroup ESPB
LidocaineDRUG

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

Group Lidocaine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Related 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.

    PMID: 28919152BACKGROUND

  • 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.

    PMID: 30921979BACKGROUND

MeSH Terms

Conditions

Thoracic Diseases

Interventions

BupivacaineSaline SolutionDental OcclusionLidocaine

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsDentistryDental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaAcetanilides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 9, 2020

Study Start

September 29, 2021

Primary Completion

March 1, 2022

Study Completion

March 15, 2022

Last Updated

May 16, 2022

Record last verified: 2022-05

Locations

TU(1)