A Comparative Study Between Regional Anesthesia in Thoracoscopes and the Conventional General Anesthesia

Phase 4

• Conditions: Pleural Neoplasms; Pulmonary Diseases or Conditions; Pleural Effusion, Malignant; Pleural Diseases; Pyopneumothorax; Pleural Empyema; Pericardial Effusion; Pleural Mesothelioma; Pulmonary Atelectasis; Mediastinal Lymphadenopathy
• Interventions: Procedure: Thoracic Epidural Anesthesia; Procedure: General Anesthesia with One Lung Ventilation

• Registration Number: NCT05077111
• Lead Sponsor: Mohamed Reda Ashour

Brief Summary

Video-assisted thoracic surgery (VATS) is usually performed with general anesthesia and single lung ventilation. However, performing thoracic surgery under awake regional anesthesia has several potential advantages including avoidance of airway trauma and ventilator dependence associated with endotracheal intubation, besides promoting enhanced recovery after surgery and shorter mean hospital stay.

Detailed Description

The aim of this study is to investigate the feasibility and the effect of Thoracic Epidural Anaesthesia for awake thoracic surgery to speed up recovery in patients as well as avoiding the complications accompanying General Anesthesia with one lung ventilation.

Type of Study: Prospective randomized clinical study. Study Setting: This study will be conducted in Ain Shams University Hospitals..

Study Period: Expected for two years starting from 2019.

Sampling Method: Randomized sampling by a computer generated random numbers table.

Sample Size: 40 patients. Sample size was calculated using PASS 11 program for sample size calculation and according to the (Pompeo et al., 2004) study, the mean PaO2 perioperatively in the awake group = -3±1.5 mmHg and in the second group = -6.5±1.83 mmHg. Sample size of 40 cases per group (total 40) can detect this difference with power 100% and α-error 0.05.

Study Timeline

• Study Start: 2020-01-15
• Status Verified: 2021-09
• Primary Completion: 2021-09-15
• Study First Submitted: 2021-09-19
• Study First Submitted QC: 2021-09-30
• Last Update Submitted: 2021-09-30
• Study First Posted: 2021-10-14
• Last Update Posted: 2021-10-14
• Study Completion: 2021-10-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• ASA less than or equal II.
• The procedure expected to be completed within 2 hours.

Exclusion Criteria

• Patients with expected difficult airway management.

  • Hemodynamically unstable patients.
  • Persistent cough or high airway secretions.
  • Severe Emphysema or clinical signs of active infectious disease.
  • Hypoxemia (PaO2 <60 mmHg) or hypercarbia (PCO2 >50 mmHg)
  • Coagulopathy (INR >1.5).
  • Obesity (BMI >30 Kg/m 2 ).
  • Infection at the injection site, allergy to local anesthetics.
  • Neurological disorders: seizures, intracranial mass or brain edema.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Thoracic Epidural Anesthesia	sole Thoracic Epidural Anesthesia
Group B	General Anesthesia with One Lung Ventilation	General Anesthesia with One Lung Ventilation

Primary Outcome Measures

Name	Time	Method
Perioperative changes in blood gases	Imediately before operation, intraoperatively per hour, and postoperatively till 24 hours	Ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2), arterial carbon dioxide tension (PaCO2). Hypoxemia is defined as peripheral oxygen saturation (SpO2) \< 92% on room air with a need for oxygen supplementation.

Secondary Outcome Measures

Name	Time	Method
Perioperative changes in heart rate	Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours	heart rate (HR) in beats per minute (bpm)
Perioperative changes in mean arterial pressure	Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours	mean arterial pressure (MAP) in mmHg
The onset of ambulance.	During the 24 hours after regaining of full motor power	Rate of occurence of falling after ambulance will be recorded in each group.
Number of episodes of Post Operative Nausea and Vomiting (PONV)	During the 24 hours postoperatively
Postoperative pain	Postoperatively at 3,12 and 24 hours	The Visual Analogue Scale (VAS) consists of a 10 cm straight line with the endpoints defining extreme limits of "no pain at all" (0 cm) and "pain as bad as it could be" (10 cm). The patient is asked to mark his pain level on the line between the two endpoints. The distance between 0 and the mark then defines the subject pain score.
Postoperative opioid needs	Postoperatively during the 24 hours after regaining sensation	Pethidine consumption
Hospital stay	from day of operation to discharge; average, 5 days

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt