Comparative Study Between Spinal Anesthesia Versus General Anesthesia in Supine Percutaneous Nephrolithotomy Operation

NCT ID: NCT07114250

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-05-30
• Study Completion Date: 2026-12-30

Brief Summary

The aim of this study is to evaluate the efficacy of spinal anesthesia as an alternative to general anesthesia in PCNL operation in supine position.

Detailed Description

Nephrolithiasis remains a common health problem around the globe. Percutaneous nephrolithotomy is the preferred modality for large and complex renal calculi. Percutaneous nephrolithotomy is the treatment of choice for calculi which fail treatment with extracorporeal shockwave lithotripsy and ureteral endoscopy.

There are variations to Percutaneous nephrolithotomy, including position, imaging modality, dilatation method, and anesthesia method. There is conflicting evidence between the appropriate use of general anesthesia versus spinal anesthesia for Percutaneous nephrolithotomy

The conventional position of Percutaneous nephrolithotomy is prone, which allows direct access to the posterior calyx with minimal risk of bowel puncture.

However, this positioning method limits the possibility of switching anesthesia from regional to general. The alternative position is supine Advantage in this position is that the spine does not overlap with kidney and fluoroscopic visualization can be achieved.

Nowadays, Percutaneous nephrolithotomy is usually performed under general anesthesia from a urological perspective, the particular advantages of general anesthesia in Percutaneous nephrolithotomy procedure include its feasibility to control tidal volume, secure patient airway, and extensibility of anesthesia time. The feasibility of controlling tidal volume minimizes renal mobility secondary to respiration while the extensibility of anesthesia time allows the surgeon to create multiple punctures with subsequently increased efficacy of the procedure . Despite the superior results of Percutaneous nephrolithotomy surgeries under general anesthesia, it has found to be associated with certain disadvantages such as its high cost and higher incidences of drug interactions. The incidence of complications is high especially when the position of patient is changed from supine to prone position. Common complications associated with use of general anesthesia i.e. injury to lung, brachial plexus, tongue and occasionally to spinal cord are its major drawback. Other minor but common side effects include postoperative nausea and vomiting On the other hand, there are recent reports regarding the use of spinal anesthesia in Percutaneous nephrolithotomy demonstrating lower post-operation pain, less drug intake, less bleeding, and reduces venous pressure in the surgery field .A limited number of prospective randomized trials have been carried out to establish which one of these procedures is better at decreasing perioperative complications. The influence of the type of anesthesia on the effectiveness of Percutaneous nephrolithotomy remains uncertain. Thus, the aim of this study is to evaluate the efficacy of spinal anesthesia as an alternative to general anesthesia in Percutaneous nephrolithotomy operation in supine position.

The aim of this study is to evaluate the efficacy of spinal anesthesia as an alternative to general anesthesia in Percutaneous nephrolithotomy operation in supine position.

Primary outcome:

• Patient satisfaction

Conditions

Spinal Anesthesia; Percutaneous Nephrolithotomy; General Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Spinal Anesthesia

Spinal Anesthesia: Patients included in this group will undergo supine Percutaneous nephrolithotomy under spinal anesthesia

Group Type: EXPERIMENTAL

spinal anesthesia

Intervention Type: PROCEDURE

Spinal Anesthesia group: Patients included in this group will undergo supine Percutaneous nephrolithotomy under spinal anesthesia

General Anesthesia

Patients included in this group will undergo supine Percutaneous nephrolithotomy under general anesthesia.

Group Type: EXPERIMENTAL

General Anesthesia

Intervention Type: PROCEDURE

General Anesthesia : Patients included in this group will undergo supine Percutaneous nephrolithotomy under general anesthesia

Interventions

spinal anesthesia

Spinal Anesthesia group: Patients included in this group will undergo supine Percutaneous nephrolithotomy under spinal anesthesia

Intervention Type: PROCEDURE

General Anesthesia

General Anesthesia : Patients included in this group will undergo supine Percutaneous nephrolithotomy under general anesthesia

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age more than 21 years old.
• Both sexes.
• American Society of Anesthesiologists physical status (I- II).
• Patient with single renal stone size 2-3cm prepared for supine Percutaneous nephrolithotomy

Exclusion Criteria

• Patient refusal.
• Pregnancy
• Morbid obese with Body mass index > 35 kg/m2.
• Contraindication for spinal anesthesia.
• Renal anomalies (horseshoe kidney, ectopic kidney).
• Presence of multiple stones or staghorn stones.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Aya Ahmed Mahmoud Ibrahim Hamouda

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aya Hamouda, Resident

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

Tanta University

Tanta, , Egypt

Countries

Egypt

Central Contacts

Aya Hamouda, Resident

Role: CONTACT

aya0ahmed.16@gmail.com

+20 12 28671528

Facility Contacts

Aya Hamouda, Resident

Role: primary

aya0ahmed.16@gmail.com

+20 12 28671528

Other Identifiers

36264MS737/11/24

Identifier Type: -

Identifier Source: org_study_id