Thoracic Epidural Anesthesia Versus Paravertebral Block for Awake Thoracotomy

NCT ID: NCT06974643

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2025-10-01

Brief Summary

This study aims to compare paravertebral block and thoracic epidural in awake thoracotomy.

Detailed Description

Pain can often persist after thoracotomy, and the incidence of chronic pain is high, with studies revealing that 30% to 50% of patients still experience pain up to five years after surgery.

Thoracic epidural blockade (TEB) blocks nerves that supply the chest with local anesthetic bilaterally, at the spinal cord level. It acts by reducing the onward transmission of painful nerve signals, but may not abolish them altogether. Paravertebral blockade (PVB) involves injecting local anesthetic into the paravertebral space, which contains spinal nerves (and sometimes even extension of the dura), white and grey rami communicantes, the sympathetic chain, and intercostal vessels, on the side of surgery.

Conditions

Thoracic Epidural Anesthesia; Paravertebral Block; Awake Thoracotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Thoracic epidural block group

Patients will preoperatively receive an awake thoracic epidural block.

Group Type: EXPERIMENTAL

Thoracic epidural block

Intervention Type: OTHER

Patients will preoperatively receive an awake thoracic epidural block.

Paravertebral block group

Patients will preoperatively receive a paravertebral block.

Group Type: EXPERIMENTAL

Paravertebral block

Intervention Type: OTHER

Patients will preoperatively receive a paravertebral block.

Interventions

Thoracic epidural block

Patients will preoperatively receive an awake thoracic epidural block.

Intervention Type: OTHER

Paravertebral block

Patients will preoperatively receive a paravertebral block.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age from 18 to 60 years.
• Both genders.
• American Society of Anesthesiologists (ASA) physical status classification II or III.
• Scheduled for thoracotomy.

Exclusion Criteria

• Poor cardiac function (ejection fraction less than 50%).
• Patients with bad pulmonary function testing (PFTs). Absolute contraindication to thoracic epidural anesthesia includes patient refusal, allergy to local anesthetics, coagulopathy, active neurologic disorders, skin infection at the insertion site, uncooperative patients, uncontrolled cough, and unfavorable anatomy for thoracic epidural.
• Thoracic spine disorders require chest wall resection or emergency thoracic surgery.
• Had a previous thoracotomy (scarring due to prior surgery can limit the effectiveness of paravertebral block, and these patients may have existing chronic pain).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Elsaid Abdel Fattah

Lecturer of Anesthesia, Surgical ICU and Pain Management, Faculty of Medicine, National Cancer Institute, Cairo University, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed E Abdel Fattah, MD

Role: CONTACT

mohamed-elsaid@cu.edu.eg

00201284475792

Facility Contacts

Mohamed E Abdel Fattah, MD

Role: primary

mohamed-elsaid@cu.edu.eg

00201284475792

Other Identifiers

AP2503-501-099-197

Identifier Type: -

Identifier Source: org_study_id