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Spinal AnesthesiaNCT07114250

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

A study testing spinal anesthesia and General Anesthesia in people with Spinal Anesthesia and Percutaneous Nephrolithotomy, run by Tanta University at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 to 65 years
What is being tested?
spinal anesthesia and General Anesthesia
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteEgypt
Study dates
30 May 2026to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aya Hamouda, Resident contact

+20 12 28671528

aya0ahmed.16@gmail.com

Egypt1 site
  • Tanta University

    Tanta

    Aya Hamouda, Resident, +20 12 28671528, aya0ahmed.16@gmail.com

Other trials in Egypt

About this study

Official title: Comparative Study Between Spinal Anesthesia Versus General Anesthesia in Patients Undergoing Supine Percutaneous Nephrolithotomy

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.

Read the 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
Being tested
spinal anesthesia, General Anesthesia
Keywords
General Anesthesia, Percutaneous nephrolithotomy, Spinal Anesthesia, Nephrolithiasis
Medical subject headings
Nephrolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • spinal anesthesiaProcedure or surgery

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

  • General AnesthesiaProcedure or surgery

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

Study groups in NCT07114250
Study groupRoleWhat they receive
Spinal AnesthesiaExperimentalSpinal Anesthesia: Patients included in this group will undergo supine Percutaneous nephrolithotomy under spinal anesthesia
Receives: Procedure: spinal anesthesia
General AnesthesiaExperimentalPatients included in this group will undergo supine Percutaneous nephrolithotomy under general anesthesia.
Receives: Procedure: General Anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient satisfaction

    Degree of patient satisfaction will be assessed according to a 5-point Likert scale (5: excellent, 4: Good, 3: Satisfactory, 2: Poor, 1: Very poor)

    Measured: 24 hours

Secondary outcomes (1)
  1. Visual analog scale

    Visual analog scale will be assessed after surgery over 24 hours using as (0 = no pain and 10 = intolerable pain).

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2025
  2. Study start30 May 2026 (estimated)
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07114250
Sponsor's protocol ID
36264MS737/11/24
Status last verified
May 2025
First submitted
4 Aug 2025
Last updated
11 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing spinal anesthesia and General Anesthesia in people with Spinal Anesthesia and Percutaneous Nephrolithotomy, run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aya Hamouda, Resident (+20 12 28671528, aya0ahmed.16@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient satisfaction (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.

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