Thoracic Epidural Anesthesia Versus Paravertebral Block for Awake Thoracotomy

NCT06974643 | Recruiting

• 1 other identifier: AP2503-501-099-197
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thoracic Epidural Anesthesia; Paravertebral Block; Awake Thoracotomy

Outcome Measures

Primary Outcomes (1)

• Intraoperative fentanyl consumption

  Additional bolus doses of fentanyl 0.5µg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.

  Intraoperatively

Secondary Outcomes (7)

• Time to the 1st rescue analgesia

  48 hours postoperatively

• Mean arterial pressure

  Till the end of surgery (Up to 2 hours)

• Heart rate

  Till the end of surgery (Up to 2 hours)

• Total morphine consumption

  48 hours postoperatively

• Degree of pain

  48 hours postoperatively

Study Arms (2)

Thoracic epidural block group

EXPERIMENTAL

Patients will preoperatively receive an awake thoracic epidural block.

Other: Thoracic epidural block

Paravertebral block group

EXPERIMENTAL

Patients will preoperatively receive a paravertebral block.

Other: Paravertebral block

Interventions

Thoracic epidural block OTHER

Patients will preoperatively receive an awake thoracic epidural block.

Thoracic epidural block group

Paravertebral block OTHER

Patients will preoperatively receive a paravertebral block.

Paravertebral block group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

Central Study Contacts

Mohamed E Abdel Fattah, MD

CONTACT

00201284475792; mohamed-elsaid@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Surgical ICU and Pain Management, Faculty of Medicine, National Cancer Institute, Cairo University, Egypt.

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 16, 2025
• Study Start: May 15, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)