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.
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
- Conditions the study is for
- Spinal Anesthesia, Percutaneous Nephrolithotomy, General Anesthesia
- 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.
Egypt1 site
Tanta University
Tanta
Aya Hamouda, Resident, +20 12 28671528, aya0ahmed.16@gmail.com
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 group | Role | What they receive |
|---|---|---|
| Spinal Anesthesia | Experimental | Spinal Anesthesia: Patients included in this group will undergo supine Percutaneous nephrolithotomy under spinal anesthesia Receives: Procedure: spinal anesthesia |
| General Anesthesia | Experimental | Patients 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.
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)
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.
- First posted11 Aug 2025
- Study start30 May 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Ahmed Mahmoud Ibrahim Hamouda, Tanta University
- Investigators
- Aya Hamouda, Resident, Principal investigator, Tanta University
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Spinal Anesthesia Versus General Anesthesia in Patients Undergoing Supine Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT07114250
- Acronym / sponsor ID
- 36264MS737/11/24
- Keywords
- General Anesthesia, Percutaneous nephrolithotomy, Spinal Anesthesia, Nephrolithiasis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Anesthesia | Experimental | Procedure: spinal anesthesiaSpinal Anesthesia: Patients included in this group will undergo supine Percutaneous nephrolithotomy under spinal anesthesia |
| General Anesthesia | Experimental | Procedure: General AnesthesiaPatients included in this group will undergo supine Percutaneous nephrolithotomy under general anesthesia. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Patient refusal.
- Pregnancy
- Morbid obese with Body mass index > 35 kg/m2.
- Contraindication for spinal anesthesia.
- Renal anomalies (horseshoe kidney, ectopic kidney).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal anesthesiaSpinal Anesthesia group: Patients included in this group will undergo supine Percutaneous nephrolithotomy under spinal anesthesia | Procedure or surgery | Spinal Anesthesia |
| General AnesthesiaGeneral Anesthesia : Patients included in this group will undergo supine Percutaneous nephrolithotomy under general anesthesia | Procedure or surgery | General Anesthesia |
Primary outcome
Patient satisfaction
Time frame: 24 hours
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)
1 secondary outcome
Visual analog scale
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aya Hamouda, Resident principal investigator
Tanta University
1 site in 1 country: see every site and its status.
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.