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

NCT05211791 | Unknown

• 1 other identifier: TEA in single lung ventilation
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Diseases; Pain, Acute

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group TEA

ACTIVE COMPARATOR

insertion of Thoracic epidural anesthesia plus GA with lung isolation using suitable size double lumen tube at level T6

Procedure: Thoracic epidural anesthesia

Group ESB

ACTIVE COMPARATOR

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

Group PVB

ACTIVE COMPARATOR

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

Interventions

erector spinae block PROCEDURE

Ultrasound-guided insertion of different analgesic procedures as paravertebral block anesthesia and paravertebral block anesthesia

Group ESB

paravertebral block anesthesia PROCEDURE

Ultrasound-guided insertion of different analgesic procedures as paravertebral block anesthesia and paravertebral block anesthesia

Group PVB

Thoracic epidural anesthesia PROCEDURE

insertion of Thoracic epidural catheter for anesthesia analgesia at level of T6

Group TEA

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• South Egypt Cancer Institute: lead

Study Sites (1)

South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt

Asyut, 0020, Egypt

RECRUITING

MeSH Terms

Conditions

Lung Diseases; Acute Pain

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alaa A Elzohry

  Lecturer of Anesthesia , ICU and pain management

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaa A Elzohry, MD

CONTACT

+201007356462; alaa.zohiry@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, ICU and Pain Relief, South Egypt Cancer Institute, Assiut University, Egypt

Study Record Dates

• First Submitted: January 2, 2022
• First Posted: January 27, 2022
• Study Start: January 10, 2022
• Primary Completion: June 10, 2023
• Study Completion: October 20, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

EG (1)