Erector Spinae Plane Block, Nephrolithotomy, HyaluronidaseNCT07102771
Efficacy of Hyaluronidase Added to Bupivacaine in Ultrasound-guided Erector Spinae Plane Block in Percutaneous Nephrolithotomy.
A study testing Ultrasound guided erector spinae plane block in people with Erector Spinae Plane Block, Nephrolithotomy, Hyaluronidase, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Evaluation of the postoperative pain via numeric rating scale (NRS) through erector spinae plane block (ESPB) by adding hyaluronidase as an adjuvant to bupivacaine on the postoperative analgesia in erector spinae plane block. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Erector Spinae Plane Block, Nephrolithotomy, Hyaluronidase
- What is being tested?
- Ultrasound guided erector spinae plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective percutaneous nephrolithotomy
- Age: adult patients between 20 - 65 years old.
- Gender: Both male and female.
- ASA Class: I and II.
Who cannot join
- Refusal of patient.
- Patients ASA class III and IV.
- Chronic kidney disease grade lll \& lV .
- Pregnancy and lactation.
- Allergy to any of the study medications.
- Addicts and drug abusers.
Show all 10Show fewer
- Patients taking corticosteroids or any cardio - active drugs.
- Severe coagulopathy ( INR >3 or platelets <70*10) .
- Fever or sepsis.
- Local infection at site of the injection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Hyaluronidase as an Adjuvant to Bupivacaine in Ultrasound-guided Erector Spinae Plane Block in Percutaneous Nephrolithotomy. Randomized Double-blind Controlled Study
Evaluation of the postoperative pain via numeric rating scale (NRS) through erector spinae plane block (ESPB) by adding hyaluronidase as an adjuvant to bupivacaine on the postoperative analgesia in erector spinae plane block.
Read the detailed description
- During mask preoxygenation, patients baseline hemodynamic parameters will be recorded regarding blood pressure and heart rate.
- General anesthesia will be standardized for all patients with : 2 µg / kg fentanyl, 2 mg/kg 2% propofol then 0.5 mg/kg atracuriam will be administered for muscle relaxation.
- Patients will be intubated and lungs mechanically ventilated to maintain end-tidal CO2 between 30 to 35 mmHg. Fresh gas flow oxygen in air 30-40% at a rate of 3 L/min .
- The patients will receive 1.2 % MAC of isoflurane .
- Top- up doses of 0.15 mg/kg atracurium will be given to maintain intraoperative muscle relaxation.
- In all patients , insufflation will be under pressure of 15 mmHg or less .
- The surgical time in all surgical procedures will be fixed in the range of two hours and by the same surgical team.
After the patient will be generally anesthesized and before starting the operation , the erector spinae plane block will be performed .
- Patients will be randomly allocated to one of the two groups and the study will be double blinded where neither the operator nor the patients know which group will be . The syringes will be prepared by the other investigators.
. In group l : ESPB with bupivacaine 0.25% (30 ml volume : 15 ml saline Plus 15 ml plain bupivacaine ) .
In group ll : ESPB with plain bupivacaine 0.25% and hyaluronidase ( 14 ml saline \& 15 ml plain bupivacaine 0.25% Plus 150 units of hyaluronidase which is equal 1 ml ) .
ESP block is most often performed using an in-plane ultrasound-guided technique. It is a paraspinal fascial plane block in which the needle placement is between the erector spinae muscle and the thoracic transverse processes, and a local anesthetic is administered, blocking the dorsal and ventral rami of the thoracic and abdominal spinal nerves (4).
USG-ESPB will be performed with the patient is in lateral position,The curvilinear ultrasound transducer should be placed in a cephalocaudal orientation over the midline of the back at the desired level. The probe should then slowly be moved laterally until the transverse process is visible. The transverse process requires differentiation from the rib at that level. The transverse process will be more superficial and wider, while the rib will be deeper and thinner. Upon verification of the transverse process, the trapezius muscle, rhomboid major muscle (if performing at T5 level or higher), and erector spinae muscle should be identified superficial to the transverse process. The Tuohy needle should be inserted superior to the ultrasound probe using an in-plane approach in the cephalad to caudal direction. The bevel of the Tuohy needle should point posteriorly and inferiorly, and advance under ultrasound guidance through the trapezius muscle, rhomboid major muscle, and erector spinae muscle and towards the transverse process; once the needle tip is below the erector spinae muscle, a small bolus of local anesthetic should be given through the Tuohy needle. The erector spinae muscle should be visualized, separating from the transverse process. This separation from the transverse process confirms the proper needle position. The local anesthetic should then be injected in 5 ml increments, with aspiration after every 5 ml to prevent intravascular injection.
- It is important to visualize the pleura very clearly at all times. The hyperechoic line of the pleura and underlying hyperechoic air artifacts move with respiration.
- Dose of hyaluronidase :
The minimum and maximum effective doses of hyaluronidase are unknown. The doses used range from 0.75 IU/mL to 300 IU/m.(8) (Table 3)
- Being tested
- Ultrasound guided erector spinae plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided erector spinae plane blockProcedure or surgery
ESP block is most often performed using an in-plane ultrasound-guided technique. It is a paraspinal fascial plane block in which the needle placement is between the erector spinae muscle and the thoracic transverse processes, and a local anesthetic is administered, blocking the dorsal and ventral rami of the thoracic and abdominal spinal nerves
| Study group | Role | What they receive |
|---|---|---|
| Group 1: ESPN with bupivacain 0.25% | Active comparator | ESPN with (30 ml volume : 15 ml saline Plus 15 ml plain bupivacaine ) . Receives: Procedure: Ultrasound guided erector spinae plane block |
| Group II : ESPN with bupivacaine 0.25 % and hyalurinidase | Active comparator | ESPN with ( 14 ml saline \& 15 ml plain bupivacaine 0.25% Plus 150 units of hyaluronidase which is equal 1 ml ) . Receives: Procedure: Ultrasound guided erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score by numeric rating scale (NRS)
Pain intensity will be estimated by a numeric rating scale (NRS) (0 = no pain, 10 = worst imaginable pain)
Measured: Started measuring on admission to PACU ( 0 time) and 2, 4, 6 and 24 hours following admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Jan 2025
- Primary completion30 Oct 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erector Spinae Plane Block, Nephrolithotomy, HyaluronidaseStudies of the same condition, open and under way.
- 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
- Model description
- Controlled arm and interventional arm
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Mohamed Ahmed Abdelhafez, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102771
- Sponsor's protocol ID
- MS-186-2025
- Status last verified
- Apr 2026
- First submitted
- 30 Jul 2025
- Last updated
- 22 Apr 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 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Hyaluronidase as an Adjuvant to Bupivacaine in Ultrasound-guided Erector Spinae Plane Block in Percutaneous Nephrolithotomy. Randomized Double-blind Controlled Study
- ClinicalTrials.gov ID
- NCT07102771
- Acronym / sponsor ID
- MS-186-2025
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 5 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.
Evaluation of the postoperative pain via numeric rating scale (NRS) through erector spinae plane block (ESPB) by adding hyaluronidase as an adjuvant to bupivacaine on the postoperative analgesia in erector spinae plane block.
Detailed description
- During mask preoxygenation, patients baseline hemodynamic parameters will be recorded regarding blood pressure and heart rate.
- General anesthesia will be standardized for all patients with : 2 µg / kg fentanyl, 2 mg/kg 2% propofol then 0.5 mg/kg atracuriam will be administered for muscle relaxation.
- Patients will be intubated and lungs mechanically ventilated to maintain end-tidal CO2 between 30 to 35 mmHg. Fresh gas flow oxygen in air 30-40% at a rate of 3 L/min .
- The patients will receive 1.2 % MAC of isoflurane .
- Top- up doses of 0.15 mg/kg atracurium will be given to maintain intraoperative muscle relaxation.
- In all patients , insufflation will be under pressure of 15 mmHg or less .
- The surgical time in all surgical procedures will be fixed in the range of two hours and by the same surgical team.
After the patient will be generally anesthesized and before starting the operation , the erector spinae plane block will be performed .
- Patients will be randomly allocated to one of the two groups and the study will be double blinded where neither the operator nor the patients know which group will be . The syringes will be prepared by the other investigators.
. In group l : ESPB with bupivacaine 0.25% (30 ml volume : 15 ml saline Plus 15 ml plain bupivacaine ) .
In group ll : ESPB with plain bupivacaine 0.25% and hyaluronidase ( 14 ml saline \& 15 ml plain bupivacaine 0.25% Plus 150 units of hyaluronidase which is equal 1 ml ) .
ESP block is most often performed using an in-plane ultrasound-guided technique. It is a paraspinal fascial plane block in which the needle placement is between the erector spinae muscle and the thoracic transverse processes, and a local anesthetic is administered, blocking the dorsal and ventral rami of the thoracic and abdominal spinal nerves (4).
USG-ESPB will be performed with the patient is in lateral position,The curvilinear ultrasound transducer should be placed in a cephalocaudal orientation over the midline of the back at the desired level. The probe should then slowly be moved laterally until the transverse process is visible. The transverse process requires differentiation from the rib at that level. The transverse process will be more superficial and wider, while the rib will be deeper and thinner. Upon verification of the transverse process, the trapezius muscle, rhomboid major muscle (if performing at T5 level or higher), and erector spinae muscle should be identified superficial to the transverse process. The Tuohy needle should be inserted superior to the ultrasound probe using an in-plane approach in the cephalad to caudal direction. The bevel of the Tuohy needle should point posteriorly and inferiorly, and advance under ultrasound guidance through the trapezius muscle, rhomboid major muscle, and erector spinae muscle and towards the transverse process; once the needle tip is below the erector spinae muscle, a small bolus of local anesthetic should be given through the Tuohy needle. The erector spinae muscle should be visualized, separating from the transverse process. This separation from the transverse process confirms the proper needle position. The local anesthetic should then be injected in 5 ml increments, with aspiration after every 5 ml to prevent intravascular injection.
- It is important to visualize the pleura very clearly at all times. The hyperechoic line of the pleura and underlying hyperechoic air artifacts move with respiration.
- Dose of hyaluronidase :
The minimum and maximum effective doses of hyaluronidase are unknown. The doses used range from 0.75 IU/mL to 300 IU/m.(8) (Table 3)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Controlled arm and interventional arm
| Arm | Type | Receives |
|---|---|---|
| Group 1: ESPN with bupivacain 0.25% | Active comparator | Procedure: Ultrasound guided erector spinae plane blockESPN with (30 ml volume : 15 ml saline Plus 15 ml plain bupivacaine ) . |
| Group II : ESPN with bupivacaine 0.25 % and hyalurinidase | Active comparator | Procedure: Ultrasound guided erector spinae plane blockESPN with ( 14 ml saline \& 15 ml plain bupivacaine 0.25% Plus 150 units of hyaluronidase which is equal 1 ml ) . |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective percutaneous nephrolithotomy
- Age: adult patients between 20 - 65 years old.
- Gender: Both male and female.
- ASA Class: I and II.
Key exclusion criteria (10 listed)
- Refusal of patient.
- Patients ASA class III and IV.
- Chronic kidney disease grade lll \& lV .
- Pregnancy and lactation.
- Allergy to any of the study medications.
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 |
|---|---|---|
| Ultrasound guided erector spinae plane blockESP block is most often performed using an in-plane ultrasound-guided technique. It is a paraspinal fascial plane block in which the needle placement is between the erector spinae muscle and the thoracic transverse processes, and a local anesthetic is administered, blocking the dorsal and ventral rami of the thoracic and abdominal spinal nerves | Procedure or surgery | Group 1: ESPN with bupivacain 0.25%, Group II : ESPN with bupivacaine 0.25 % and hyalurinidase |
Primary outcome
Postoperative pain score by numeric rating scale (NRS)
Time frame: Started measuring on admission to PACU ( 0 time) and 2, 4, 6 and 24 hours following admission
Pain intensity will be estimated by a numeric rating scale (NRS) (0 = no pain, 10 = worst imaginable pain)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided erector spinae plane block in people with Erector Spinae Plane Block, Nephrolithotomy, Hyaluronidase, run by Kasr El Aini Hospital 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 10 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: finished, as of the sponsor's last update on 22 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 score by numeric rating scale (NRS) (time frame: Started measuring on admission to PACU ( 0 time) and 2, 4, 6 and 24 hours following admission). 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 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.