Comparison of the Efficacy of Erector Spina Plane Block and Thoracic Epidural Analgesia After Thoracotomy

NCT05402917 | Completed

• 1 other identifier: espVStea
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In patients who undergoing lobectomy with thoracotomy incision, the effectiveness of erector spina plane block in post-operative analgesia management is at least as much as thoracic epidural anesthesia.

Conditions

Pain, Postoperative

Keywords

ESPB; TEA; THORACOTOMY

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale (VAS) Change

  The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

  The first 24 hours postoperatively is the end time for primary outcome measurement.Visual Analogue Scale (VAS) change values for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.

• Wong-Baker Face Pain Scale (FS) Change

  The scale shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable.

  The first 24 hours postoperatively is the end time for primary outcome measurement.Wong-Baker Face Pain Scale(FS) values change for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.

Secondary Outcomes (5)

• Hemodynamic Values Change

  The first 24 hours postoperatively is the end time for secondary outcome measurement. Hemodynamic values change for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.

• Pulse Oximetry(SpO2) Change

  The first 24 hours postoperatively is the end time for secondary outcome measurement. Pulse Oximetry(SpO2) change values for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.

• Postoperative Nausea and Vomiting(PONV) Change

  The first 24 hours postoperatively is the end time for secondary outcome measurement. Postoperative nausea or vomiting change for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.

• Nonsteroidal Anti-inflammatory Drug Usage Need Change

  The first 24 hours postoperatively is the end time for secondary outcome measurement. Nonsteroidal anti-inflammatory drug usage need change for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.

• Opioid Drug Usage Need Change

  The first 24 hours postoperatively is the end time for secondary outcome measurement. Opioid drug usage need change for both groups will be recorded at 0, 2, 4, 8, 16 and 24 hours after their admittance to the intensive care unit.

Study Arms (2)

Thoracic Epidural Analgesia (TEA)

For patients undergoing TEA is done under general anesthesia after surgery procedure.Once the catheter is secured, a bolus dose of 15 ml of 0.25% bupivacaine will be administered as an epidural injection through the catheter, followed by a continuous infusion of 0.125% bupivacaine at a rate of 0.1 mL/kg/h for the postoperative 24-hour period.

Erector Spina Plan Block (ESPB)

For patients undergoing ESPB is done under general anesthesia after surgery procedure.A bolus dose of 15 mL of 0.25% bupivacaine will be administered from the inserted catheter. Subsequently, 0.125% bupivacaine will be given continuously at a rate of 0.1 mL/kg/h for up to 24 hours post-operatively.

Procedure: Erector Spinae Plane Block

Interventions

Erector Spinae Plane Block PROCEDURE

Interfascial plane (area) blocks are blocks in which the local anesthetic agent is injected into the potential area between the two fasciae. The ESPB we used in our study is a member of interfascial plane blocks. The erector is applied between the spinal muscle and the transverse process, spreading the drug from the injection site to both cranial and caudal. Unlike other defined interfascial plane blocks, ESPB can show paraspinal block characteristics since the injection site is above the transverse process.

Erector Spina Plan Block (ESPB)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing lobectomy with thoracotomy incision

You may qualify if:

• Lobectomy planned with thoracotomy incision;
• Adult aged 18-75;
• American Society of Anesthesiology(ASA) score1-3.

You may not qualify if:

• Obesity (BMI greater than 35 kg/m2)
• Local infection at the injection site,
• Presence of known coagulopathy
• Bone or brain metastasis
• Having impaired liver or kidney function
• Patients who cannot evaluate VAS as cognitive function
• Patients who cannot use the Patient-Controlled Analgesia (PCA) pump as a -cognitive function
• History of chronic pain medication use
• Allergy to the drugs to be used in the study
• Withdrawing consent

Sponsors & Collaborators

• Mesut Aslan: lead

Study Sites (1)

Dr.Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asistant Doctor

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 2, 2022
• Study Start: February 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

TU (1)