Thoracic Spinal Versus Thoracic Epidural Anesthesia for Patients with Chronic Obstructive Pulmonary Disease Undergoing Supine Percutaneous Nephrolithotomy for Management of Renal Stones.

NCT06663488 | Completed DMC

• 1 other identifier: 2011
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Owing to the elevated risk of perioperative comorbidities, chronic obstructive and restrictive pulmonary disorders can be a challenging task for the anesthetist. Endotracheal intubation and intermittent positive pressure ventilation (IPPV), two hallmarks of general anesthesia (GA), are known to increase the risk of serious complications such as barotrauma, laryngospasm, and bronchospasm. Patients who had neuraxial anesthesia had a lower rate of pulmonary and cardiac problems and deep venous thrombosis after surgery compared to those who received GA. Global Initiatives for Chronic Obstructive Lung Disease (GOLD) described COPD as a pulmonary disease with an inflammatory process that affects both the central and peripheral tracheobronchial tree, the pulmonary vasculature, and the pulmonary parenchyma. This persistent and cumulative process leads to the narrowing of the small airways, which is difficult to reverse, along with changes in the smooth muscle of the airway, increased secretion of mucus-secreting glands and goblet cells, and the development of perivascular pulmonary fibrosis. These changes contribute to the development of pulmonary hypertension and increase the workload on the right ventricle. Ultimately, COPD is characterized by the obstruction of airflow during expiration. When the small airway becomes inflamed, the condition is called "obstructive bronchiolitis," and when the lung tissue becomes destroyed, the condition is called "emphysema.". Impairment in ventilation and perfusion (V/Q) ratios and pulmonary mechanics come from air trapping and dynamic hyperinflation caused by obstruction in small airways. Patients with COPD have a wide range of options for anesthesia, depending on illness stage, type of surgery, and length of operation. General anesthesia (GA) is known to increase the risk of problems for patients with COPD, especially when paired with endotracheal tube insertion and mechanical ventilation. Increased risk of hypoxemia and intra- and postoperative pulmonary complications; laryngospasm; bronchospasm; lung barotrauma; hemodynamic instability; hypercarbia; prolonged postoperative mechanical ventilation; and difficulty in weaning. To address these challenges, there has been a growing inclination towards employing various forms of regional anesthetic techniques whenever possible, including central neuraxial block. This approach aims to minimize the risks associated with general anesthesia and its potential complications, providing a safer alternative for COPD patients undergoing different types of surgical procedures. Regional blocking, as opposed to GA, has been found to improve pulmonary outcomes in patients with severe COPD and patients with normal lung function.

Conditions

Postoperative Pain; Satisfaction with Care

Keywords

COPD; PNL; Thoracic epidural anesthesia; Thoracic spinal anesthesia

Outcome Measures

Primary Outcomes (2)

• 1st analgesic requirment

  The time at which 1st analgesic was given

  24 hours

• Respiratory monitoring

  Respiratory rate (rate/min)

  preoperatively (baseline values), intraoperatively at 30 min, 1 h, at end of surgery, and postoperatively at 1 h after surgery

Secondary Outcomes (2)

• PaCO2

  preoperatively (baseline values), intraoperatively at 30 min, 1 h, at end of surgery, and postoperatively at 1 h after surgery

• PaO2

  preoperatively (baseline values), intraoperatively at 30 min, 1 h, at end of surgery, and postoperatively at 1 h after surgery

Study Arms (2)

Thoracic spinal anesthesia

ACTIVE COMPARATOR

Thoracic spinal anesthesia: at T5-T6 or T6-T7 level with a 27G with 4 ml of isobaric bupivacaine 0.5% plus 0.5 ml of 250 ug morphine

Procedure: Thoracic spinal anesthesia

thoracic epidural anesthesia

ACTIVE COMPARATOR

Thoracic epidural anesthesia: The epidural needle was inserted At T6-8 space, After verification of the epidural space by resistance loss technique, a test dose of 2 ml of 0.5% bupivacaine will be injected. In the Cephalad direction, the epidural catheter was threaded 3 cm into the epidural space. A total dose of 8-12 ml 0.5 percent plain bupivacaine was injected

Procedure: Thoracic epidural anesthesia

Interventions

Thoracic epidural anesthesia PROCEDURE

The epidural needle was inserted At T6-8 space, After verification of the epidural space by resistance loss technique, a test dose of 2 ml of 0.5% bupivacaine was injected. In the Cephalad direction, the epidural catheter was threaded 3 cm into the epidural space. A total dose of 8-12 ml 0.5 percent plain bupivacaine was administered .

thoracic epidural anesthesia

Thoracic spinal anesthesia PROCEDURE

Thoracic spinal anesthesia: At T5-T6 or T6-T7, a 27G needle was inserted. The needle's stylet will be removed and the hub observed for free flow of CSF; once flow of clear CSF, 4 ml of isobaric bupivacaine 0.5% plus 0.5 ml of 250 ug morphine was injected

Thoracic spinal anesthesia

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status classes (II and III) complaining of COPD scheduled for various elective (PNL) for renal stone.
• All patients known that they had COPD with stages I-III (mild to severe airflow limitation) with forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) less than 70% of the normal value.

You may not qualify if:

• Patients reject neuraxial anesthesia and prefer GA.
• Local back infection.
• Lumbar or thoracic spine deformity.
• Coagulopathy or platelet dysfunction.
• Diabetic patients with peripheral or central neurological dysfunction.
• Pulmonary artery systolic pressure greater than 50 mmHg.
• Obesity (BMI \>30).
• ASA physical status class less than III.
• PaCO2 of more than 45 mmHg and PaO2 of less than 60 mmHg on room air.
• Patients with allergy to local anesthetic (LA) drugs.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, Sohag Governorate, 52514, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator. Lecturer of Anesthesiology and ICU

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 29, 2024
• Study Start: August 15, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 2, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)