Kidney StonesBLOCK-PCNLNCT07359391
Dual Approach External Oblique Fascial Plane Block Versus Erector Spinae Plane Block for Post Operative Analgesia in Percutaneous Nephrolithotomy
A study testing Erector Spinae Plane Block, Dual External Oblique Fascial Plane Block and General Anesthesia in people with Kidney Stones, run by Zagazig University.
Trial summary
Here is a patient-friendly, ClinicalTrials.gov-compliant Brief Summary written in plain language, avoiding technical jargon as much as possible while remaining accurate. You can copy-paste this directly into the Brief Summary field. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Stones
- What is being tested?
- Erector Spinae Plane Block, Dual External Oblique Fascial Plane Block and General Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2026to Aug 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Body mass index (BMI) between 18 and 35 kg/m²
- Scheduled for unilateral percutaneous nephrolithotomy (PCNL)
- Ability to understand the study protocol and provide written informed conse
Who cannot join
- Known allergy or hypersensitivity to local anesthetics
- Infection at the site of block injection
- Coagulopathy or bleeding disorders
- Chronic pain syndrome or long-term opioid use
- Severe hepatic, renal, or cardiac disease
- -
About this study
Here is a patient-friendly, ClinicalTrials.gov-compliant Brief Summary written in plain language, avoiding technical jargon as much as possible while remaining accurate.
You can copy-paste this directly into the Brief Summary field.
Read more
- Brief Summary
Percutaneous nephrolithotomy (PCNL) is a common surgical procedure used to remove large kidney stones. Patients often experience moderate to severe pain after this surgery due to the surgical incision and irritation of the kidney and surrounding tissues. Effective pain control after PCNL is important to improve patient comfort, reduce the need for opioid medications, and enhance recovery.
Several regional anesthesia techniques have been developed to reduce postoperative pain. Two of these techniques are the dual-approach external oblique fascial plane block and the erector spinae plane block. Both techniques involve injecting a local anesthetic near specific muscle planes using ultrasound guidance to reduce pain signals from the surgical area. However, it is not yet clear which of these two techniques provides better pain relief after PCNL.
This study aims to compare the effectiveness of the dual-approach external oblique fascial plane block and the erector spinae plane block in controlling pain after PCNL surgery. Adult patients scheduled for PCNL will be randomly assigned to receive one of the two nerve block techniques or standard general anesthesia alone. Pain levels, additional pain medication requirements, patient satisfaction, and any block-related complications will be assessed during the first 24 hours after surgery.
The results of this study may help determine the most effective regional anesthesia technique for improving postoperative pain management in patients undergoing PCNL.
Read the detailed description
Here is a ClinicalTrials.gov-compliant Detailed Description that is clear, structured, non-duplicative, and suitable for reviewers.
It expands on the Brief Summary without repeating it, focuses on study design, interventions, and assessments, and avoids excessive technical detail already covered elsewhere.
You can copy-paste this directly into the Detailed Description field.
- Detailed Description
This prospective, randomized, double-blind controlled clinical study is designed to compare the postoperative analgesic efficacy of two ultrasound-guided regional anesthesia techniques-the dual-approach external oblique fascial plane block and the erector spinae plane block-in adult patients undergoing percutaneous nephrolithotomy (PCNL).
Eligible patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I or II, scheduled for unilateral PCNL under general anesthesia, will be enrolled after obtaining written informed consent. Participants will be randomly allocated in a 1:1:1 ratio into three groups: one group receiving the dual-approach external oblique fascial plane block, a second group receiving the erector spinae plane block, and a control group receiving general anesthesia alone according to the institutional standard analgesic protocol. Randomization will be performed using a computer-generated sequence, with allocation concealment ensured by sealed opaque envelopes. Outcome assessors and data analysts will be blinded to group allocation.
All patients will receive standardized general anesthesia. The regional blocks, when assigned, will be performed under ultrasound guidance using local anesthetic within safe dosage limits, following aseptic precautions. The dual-approach external oblique fascial plane block will involve injections at both the lateral abdominal wall and costal margin, while the erector spinae plane block will be performed at the thoracic paraspinal level. No regional anesthesia technique will be administered to patients in the control group.
Postoperative pain will be evaluated using the visual analog scale (VAS) at predefined time points during the first 24 hours after surgery. The primary outcome measure is postoperative pain intensity as assessed by VAS. Secondary outcome measures include total opioid (nalbuphine) consumption during the first 24 hours, intraoperative nociceptive responses as reflected by changes in heart rate and mean arterial pressure, patient satisfaction with pain management, and the incidence of block-related or anesthesia-related complications.
Rescue analgesia will be administered according to a predefined protocol when pain scores exceed the accepted threshold. All adverse events and complications related to the regional anesthesia techniques or general anesthesia will be monitored and documented throughout the intraoperative and postoperative periods.
The findings of this study are expected to clarify the relative effectiveness and safety of these two interfascial plane blocks for postoperative pain management following PCNL and may help guide clinical practice in regional anesthesia for urologic surgery.
- Conditions
- Kidney Stones
- Being tested
- Erector Spinae Plane Block, Dual External Oblique Fascial Plane Block, General Anesthesia
- Keywords
- Percutaneous Nephrolithotomy, Postoperative Analgesia, Dual Approach External Oblique Fascial Plane Block, Erector Spinae Plane Block, Pain Management
- Medical subject headings
- Kidney Calculi, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Ultrasound-guided erector spinae plane block performed with local anesthetic in addition to standard general anesthesia for percutaneous nephrolithotomy.
Dual External Oblique Fascial Plane BlockProcedure or surgery
Ultrasound-guided dual-approach (lateral and costal) external oblique fascial plane block performed using local anesthetic in addition to standard general anesthesia for percutaneous nephrolithotomy.
General AnesthesiaProcedure or surgery
Routine general anesthesia according to institutional standard anesthetic and analgesic protocol without the addition of any regional anesthesia technique.
| Study group | Role | What they receive |
|---|---|---|
| Arm Name: Dual External Oblique Fascial Plane Block Arm Type: Experimental | Experimental | Participants receive ultrasound-guided dual-approach (lateral and costal) external oblique fascial plane block in addition to standard general anesthesia for percutaneous nephrolithotomy. Receives: Procedure: Dual External Oblique Fascial Plane Block |
| Erector Spinae Plane Block | Experimental | Participants receive ultrasound-guided erector spinae plane block in addition to standard general anesthesia for percutaneous nephrolithotomy. Receives: Procedure: Erector Spinae Plane Block |
| General Anesthesia Only | Active comparator | articipants receive routine general anesthesia according to institutional standard analgesic protocol without the addition of any regional anesthesia technique. Receives: Procedure: General Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Postoperative pain will be assessed using the Visual Analog Scale (VAS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain, measured at predefined time points during the first 24 hours after surgery.
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start12 Jan 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amira S kenawy ,md, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359391
- Sponsor's protocol ID
- ZU_IRB# 1985 /13-Jan-2026
- Other IDs
- ZU_IRB# 1985 /13-Jan-2026
- Acronym
- BLOCK-PCNL
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Approach External Oblique Fascial Plane Block Versus Erector Spinae Plane Block for Post Operative Analgesia in Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT07359391
- Acronym / sponsor ID
- BLOCK-PCNL / ZU_IRB# 1985 /13-Jan-2026
- Conditions
- Kidney Stones
- Keywords
- Percutaneous Nephrolithotomy, Postoperative Analgesia, Dual Approach External Oblique Fascial Plane Block, Erector Spinae Plane Block, Pain Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 12 Jan 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 22 Jan 2026 (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.
Here is a patient-friendly, ClinicalTrials.gov-compliant Brief Summary written in plain language, avoiding technical jargon as much as possible while remaining accurate.
You can copy-paste this directly into the Brief Summary field.
- Brief Summary
Percutaneous nephrolithotomy (PCNL) is a common surgical procedure used to remove large kidney stones. Patients often experience moderate to severe pain after this surgery due to the surgical incision and irritation of the kidney and surrounding tissues. Effective pain control after PCNL is important to improve patient comfort, reduce the need for opioid medications, and enhance recovery.
Several regional anesthesia techniques have been developed to reduce postoperative pain. Two of these techniques are the dual-approach external oblique fascial plane block and the erector spinae plane block. Both techniques involve injecting a local anesthetic near specific muscle planes using ultrasound guidance to reduce pain signals from the surgical area. However, it is not yet clear which of these two techniques provides better pain relief after PCNL.
This study aims to compare the effectiveness of the dual-approach external oblique fascial plane block and the erector spinae plane block in controlling pain after PCNL surgery. Adult patients scheduled for PCNL will be randomly assigned to receive one of the two nerve block techniques or standard general anesthesia alone. Pain levels, additional pain medication requirements, patient satisfaction, and any block-related complications will be assessed during the first 24 hours after surgery.
The results of this study may help determine the most effective regional anesthesia technique for improving postoperative pain management in patients undergoing PCNL.
Detailed description
Here is a ClinicalTrials.gov-compliant Detailed Description that is clear, structured, non-duplicative, and suitable for reviewers.
It expands on the Brief Summary without repeating it, focuses on study design, interventions, and assessments, and avoids excessive technical detail already covered elsewhere.
You can copy-paste this directly into the Detailed Description field.
- Detailed Description
This prospective, randomized, double-blind controlled clinical study is designed to compare the postoperative analgesic efficacy of two ultrasound-guided regional anesthesia techniques-the dual-approach external oblique fascial plane block and the erector spinae plane block-in adult patients undergoing percutaneous nephrolithotomy (PCNL).
Eligible patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I or II, scheduled for unilateral PCNL under general anesthesia, will be enrolled after obtaining written informed consent. Participants will be randomly allocated in a 1:1:1 ratio into three groups: one group receiving the dual-approach external oblique fascial plane block, a second group receiving the erector spinae plane block, and a control group receiving general anesthesia alone according to the institutional standard analgesic protocol. Randomization will be performed using a computer-generated sequence, with allocation concealment ensured by sealed opaque envelopes. Outcome assessors and data analysts will be blinded to group allocation.
All patients will receive standardized general anesthesia. The regional blocks, when assigned, will be performed under ultrasound guidance using local anesthetic within safe dosage limits, following aseptic precautions. The dual-approach external oblique fascial plane block will involve injections at both the lateral abdominal wall and costal margin, while the erector spinae plane block will be performed at the thoracic paraspinal level. No regional anesthesia technique will be administered to patients in the control group.
Postoperative pain will be evaluated using the visual analog scale (VAS) at predefined time points during the first 24 hours after surgery. The primary outcome measure is postoperative pain intensity as assessed by VAS. Secondary outcome measures include total opioid (nalbuphine) consumption during the first 24 hours, intraoperative nociceptive responses as reflected by changes in heart rate and mean arterial pressure, patient satisfaction with pain management, and the incidence of block-related or anesthesia-related complications.
Rescue analgesia will be administered according to a predefined protocol when pain scores exceed the accepted threshold. All adverse events and complications related to the regional anesthesia techniques or general anesthesia will be monitored and documented throughout the intraoperative and postoperative periods.
The findings of this study are expected to clarify the relative effectiveness and safety of these two interfascial plane blocks for postoperative pain management following PCNL and may help guide clinical practice in regional anesthesia for urologic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm Name: Dual External Oblique Fascial Plane Block Arm Type: Experimental | Experimental | Procedure: Dual External Oblique Fascial Plane BlockParticipants receive ultrasound-guided dual-approach (lateral and costal) external oblique fascial plane block in addition to standard general anesthesia for percutaneous nephrolithotomy. |
| Erector Spinae Plane Block | Experimental | Procedure: Erector Spinae Plane BlockParticipants receive ultrasound-guided erector spinae plane block in addition to standard general anesthesia for percutaneous nephrolithotomy. |
| General Anesthesia Only | Active comparator | Procedure: General Anesthesiaarticipants receive routine general anesthesia according to institutional standard analgesic protocol without the addition of any regional anesthesia technique. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Body mass index (BMI) between 18 and 35 kg/m²
- Scheduled for unilateral percutaneous nephrolithotomy (PCNL)
- Ability to understand the study protocol and provide written informed conse
Key exclusion criteria (6 listed)
- Known allergy or hypersensitivity to local anesthetics
- Infection at the site of block injection
- Coagulopathy or bleeding disorders
- Chronic pain syndrome or long-term opioid use
- Severe hepatic, renal, or cardiac disease
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 |
|---|---|---|
| Erector Spinae Plane BlockUltrasound-guided erector spinae plane block performed with local anesthetic in addition to standard general anesthesia for percutaneous nephrolithotomy. | Procedure or surgery | Erector Spinae Plane Block |
| Dual External Oblique Fascial Plane BlockUltrasound-guided dual-approach (lateral and costal) external oblique fascial plane block performed using local anesthetic in addition to standard general anesthesia for percutaneous nephrolithotomy. | Procedure or surgery | Arm Name: Dual External Oblique Fascial Plane Block Arm Type: Experimental |
| General AnesthesiaRoutine general anesthesia according to institutional standard anesthetic and analgesic protocol without the addition of any regional anesthesia technique. | Procedure or surgery | General Anesthesia Only |
Primary outcome
Postoperative Pain Intensity
Time frame: First 24 hours postoperatively
Postoperative pain will be assessed using the Visual Analog Scale (VAS; 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain, measured at predefined time points during the first 24 hours after surgery.
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 22 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block, Dual External Oblique Fascial Plane Block and General Anesthesia in people with Kidney Stones, run by Zagazig University.
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 5 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: First 24 hours postoperatively). 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 22 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.