Two Bupivacaine Concentrations for Erector Spinae Plane Block in Percutaneous Nephrolithotomy (NCT07653230) | Clinical Trial Compass
CompletedNot Applicable
Two Bupivacaine Concentrations for Erector Spinae Plane Block in Percutaneous Nephrolithotomy
Turkey (Türkiye)60 participantsStarted 2024-07-01
Plain-language summary
People who undergo percutaneous nephrolithotomy (PNL), a procedure used to remove kidney stones, often experience pain after surgery. An ultrasound-guided erector spinae plane block (ESPB) is commonly used to help reduce this pain.
This study compares two different concentrations of bupivacaine, a local anesthetic medication, used during ESPB. Participants undergoing PNL will receive either 0.25% or 0.375% bupivacaine as part of their pain management.
Researchers will compare pain scores, the need for additional pain medication, and changes in blood markers related to inflammation after surgery. The aim of the study is to determine whether one concentration provides better pain control or influences the inflammatory response differently after PNL.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age between 18 and 70 years.
* Scheduled to undergo elective percutaneous nephrolithotomy (PNL).
* American Society of Anesthesiologists (ASA) physical status I-III.
* Received ultrasound-guided thoracic erector spinae plane block (ESPB) before surgery.
* Willing and able to provide written informed consent.
Exclusion Criteria:
* Inability to assess pain using the Visual Analog Scale (VAS).
* Advanced cardiovascular disease.
* Coagulopathy or bleeding disorders.
* Opioid use disorder.
* Body mass index (BMI) ≥ 40 kg/m².
* Infection at the planned injection site.
* Known allergy or hypersensitivity to bupivacaine, other local anesthetics, or study-related medications.
* Withdrawal of consent during the study period.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared two different concentrations of bupivacaine for a nerve block called an erector spinae plane block during percutaneous nephrolithotomy — is this type of nerve block something that's offered at our hospital, and could it help reduce my pain after surgery?
2Since this study was measuring how much opioid pain medication patients needed after the procedure, does the data suggest that one concentration of bupivacaine worked better than the other at reducing opioid use, and what does that mean for my recovery?
3This trial is already completed — has the results been published yet, and if so, what did they find about which bupivacaine concentration was safer or more effective for managing post-procedure pain?
4Given that this was a 'Phase NA' study focused specifically on the nerve block technique rather than a new drug, how does this type of regional anesthesia compare to the standard pain management approach you'd use for my percutaneous nephrolithotomy?
5If the erector spinae plane block used in this trial is an option for me, what are the potential risks of the block itself, and are there any reasons based on my specific health situation why it might not be appropriate?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative pain intensity assessed using the Visual Analog Scale (VAS) and total opioid consumption