TEA, ESB and Paravertebral Block During Single-lung Ventilation for Lung Resection

Comparison Between Thoracic Epidural Anaesthesia, Erector Spinae Block and Paravertebral Block During Single-lung Ventilation for Lung Resection in Lateral Decubitus Position: A Prospective Randomized Study

Thoracotomy operations are known to be painful surgical procedures, so providing effective intraoperative and postoperative analgesia is so important for all anaesthesiologists. Ineffective pain management interferes with deep breathing, coughing, and remobilization resulting in atelectasis and pneumonia.

Ultrasound-guided ESP block is a myofascial plane block that provides analgesia for thoracic or abdominal segmental innervation depending on the level of the injection site. Thoracic epidural analgesia (TEA) is considered the gold standard analgesic technique for thoracic surgeries. But the invasiveness of this technique, the rare but serious neurologic complications and the failure rates up to 30% are the disadvantages of epidural analgesia

Study Overview

• Status: Recruiting
• Conditions: Lung Diseases; Pain, Acute
• Intervention / Treatment: Procedure: Thoracic epidural anesthesia; Procedure: erector spinae block; Procedure: paravertebral block anesthesia

Detailed Description

The aim of this study is to compare the effect of different blocks as TEA, erector spinae block or paravertebral block on improving peri-operative analgesia and post-operative outcome in pulmonary resection in adult patients.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alaa A Elzohry, MD; Phone Number: +201007356462; Email: alaa.zohiry@hotmail.com

Study Locations

• Egypt
  • Assiut, Egypt, 0020
    • Recruiting
    • South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
    • Contact: Alaa A. Elzohry, MD; Phone Number: +2001007356462; Email: alaa.zohiry@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• aged between 18 to 70 years old for elective lung resection. with American Society of Anesthesiology physical status (ASA-PS) I-III

Exclusion Criteria:

• Total pneumonectomy
• Hepatic or renal dysfunction.
• contraindications for epidural anesthesia as Coagulopathy and neurological and spinal deficits.
• emergency cases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group TEA; insertion of Thoracic epidural anesthesia plus GA with lung isolation using suitable size double lumen tube at level T6	Procedure: Thoracic epidural anesthesia; insertion of Thoracic epidural catheter for anesthesia analgesia at level of T6
Active Comparator: Group ESB; U/S guided erector spinae block anesthesia using 15 ml local anesthesia plus GA with lung isolation using a suitable size double-lumen tube	Procedure: erector spinae block; Ultrasound-guided insertion of different analgesic procedures as paravertebral block anesthesia and paravertebral block anesthesia
Active Comparator: Group PVB; U/S guided paravertebral block anesthesia using 15 ml local anesthesia as total volume plus GA with lung isolation using suitable size double lumen tube	Procedure: paravertebral block anesthesia; Ultrasound-guided insertion of different analgesic procedures as paravertebral block anesthesia and paravertebral block anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peri-operative analgesia	Visual Analogue score (resting and during cough) from 0 (no pain) to 10 (worst pain pain measurement	up to 48 hours postoperative

Collaborators and Investigators

• Sponsor: South Egypt Cancer Institute
• Investigators: Principal Investigator: Alaa A Elzohry, Lecturer of Anesthesia , ICU and pain management

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Anticipated): June 10, 2023
• Study Completion (Anticipated): October 20, 2023

Study Registration Dates

• First Submitted: January 2, 2022
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 7, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pain; Neurologic Manifestations; Lung Diseases; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: TEA in single lung ventilation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No