- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07653230
Two Bupivacaine Concentrations for Erector Spinae Plane Block in Percutaneous Nephrolithotomy (ESPB-PNL)
Effects of Two Different Bupivacaine Concentrations in Ultrasound-Guided Thoracic Erector Spinae Plane Block on Postoperative Pain and Inflammatory Biomarkers After Percutaneous Nephrolithotomy
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Percutaneous nephrolithotomy (PNL) is the standard treatment for large and complex renal stones. Despite its minimally invasive nature, postoperative pain remains an important clinical concern and may adversely affect recovery, mobilization, and patient satisfaction. Ultrasound-guided thoracic erector spinae plane block (ESPB) has been increasingly incorporated into multimodal analgesia protocols because of its simplicity, safety profile, and effectiveness in reducing postoperative pain.
The optimal concentration of bupivacaine for ESPB in patients undergoing PNL remains unclear. This study was designed to compare the effects of two different concentrations of bupivacaine (0.25% and 0.375%) administered during ultrasound-guided thoracic ESPB on postoperative pain control and inflammatory response following PNL.
Adult patients scheduled for elective PNL were enrolled. ESPB was performed at the T10 vertebral level under ultrasound guidance before surgery. Participants received 20 mL of either 0.25% or 0.375% bupivacaine. Standard perioperative anesthetic and postoperative analgesic protocols were applied to all participants.
The primary outcome was postoperative pain intensity assessed using Visual Analog Scale (VAS) scores at predefined postoperative time points. Secondary outcomes included intraoperative fentanyl consumption, postoperative tramadol consumption, patient-controlled analgesia requirements, postoperative nausea and vomiting, patient satisfaction, and perioperative changes in inflammatory biomarkers, including the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR).
Demographic characteristics, stone-related variables, operative data, and perioperative hemodynamic parameters were recorded. Statistical analyses were performed to compare postoperative pain outcomes, analgesic requirements, and inflammatory biomarker responses between the study groups.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Mamak
-
Ankara, Mamak, Turkey (Türkiye), 06420
- Ankara Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
group 1
0.25% Bupivacaine ESPB
|
Ultrasound-guided thoracic erector spinae plane block was performed at the T10 vertebral level before surgery by an experienced anesthesiologist.
A total volume of 20 mL bupivacaine was administered.
Participants received either 0.25% or 0.375% bupivacaine according to the study cohort.
The block was used as part of a multimodal analgesia protocol for postoperative pain management following percutaneous nephrolithotomy.
|
|
group 2
0.375% bupivacaine ESPB
|
Ultrasound-guided thoracic erector spinae plane block was performed at the T10 vertebral level before surgery by an experienced anesthesiologist.
A total volume of 20 mL bupivacaine was administered.
Participants received either 0.25% or 0.375% bupivacaine according to the study cohort.
The block was used as part of a multimodal analgesia protocol for postoperative pain management following percutaneous nephrolithotomy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain intensity assessed using the Visual Analog Scale (VAS) and total opioid consumption
Time Frame: 36 hours after surgery
|
Postoperative pain intensity was assessed using the Visual Analog Scale (VAS; 0-10), where higher scores indicate greater pain severity.
Pain scores and Total intraoperative and postoperative opioid consumption were recorded at 1, 3, 6, 12, 24, and 36 hours after surgery.
|
36 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
inflammatory markers
Time Frame: 24 hours after surgery
|
Changes in neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio measured before surgery and at 12 and 24 hours after surgery.
|
24 hours after surgery
|
Collaborators and Investigators
Investigators
- Study Chair: suna akın takmaz, proffessor doctor, University of Health Sciences, Ankara Training and Research Hospital, Ankara, Türkiye
Publications and helpful links
General Publications
- Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Altiparmak B, Korkmaz Toker M, Uysal AI, Gumus Demirbilek S. Comparison of the efficacy of erector spinae plane block performed with different concentrations of bupivacaine on postoperative analgesia after mastectomy surgery: ramdomized, prospective, double blinded trial. BMC Anesthesiol. 2019 Mar 4;19(1):31. doi: 10.1186/s12871-019-0700-3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-24-130
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nephrolithiasis
-
Mayo ClinicCompletedNephrolithiasis, Calcium Oxalate | Nephrolithiasis, Calcium PhosphateUnited States
-
Kırıkkale UniversityCompletedKidney Calculi Nephrolithiasis Urolithiasis Renal Stone
-
University of British ColumbiaRecruiting
-
University Hospital Inselspital, BerneCompletedCalcium NephrolithiasisSwitzerland
-
University of Texas Southwestern Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)WithdrawnUric Acid NephrolithiasisUnited States
-
Lady Reading Hospital, PakistanKhyber Teaching HospitalCompletedNephrolithiasis | Kidney Stones | Pediatric NephrolithiasisPakistan
-
University of Texas Southwestern Medical CenterCompletedNephrolithiasis, Uric AcidUnited States
-
Ningbo No. 1 HospitalNot yet recruitingIntraoperative Complications | Ureteroscopy | Urolithiasis, Calcium Oxalate | Therapeutic Irrigation
-
Icahn School of Medicine at Mount SinaiCompleted
-
Beni-Suef UniversityRecruiting
Clinical Trials on Erector spinae plane block (ESPB)
-
Istanbul Saglik Bilimleri UniversityCompletedColorectal Surgery | Robotic Surgery | Erector Spinae Plane Block | Postoperative Pain ManagementTurkey (Türkiye)
-
Sohag UniversityNot yet recruitingLaparoscopic Cholecystectomy Surgery Postoperative AnalgesiaEgypt
-
Karadeniz Technical UniversityCompletedErector Spinae Plane Block | Postoperative Pain Management | Median Sternotomy | Open-heart SurgeryTurkey (Türkiye)
-
Damanhour Teaching HospitalRecruiting
-
AUSL Romagna RiminiRecruitingCesarean Section | Post Operative PainItaly
-
Uludag UniversityRecruitingPostoperative Pain | Acute Pain | Cardiac Surgery | Pain Management | Sternotomy PainTurkey (Türkiye)
-
National Cancer Institute, EgyptRecruiting
-
Sanliurfa Education and Research HospitalRecruitingErector Spinae Plane Block | Inguinal Hernia Unilateral | Quality of Recovery (QoR-15) | Numeric Rating Scale | Return to Daily ActivityTurkey (Türkiye)
-
General Hospital of Ningxia Medical UniversityRecruiting
-
Kutahya Health Sciences UniversityRecruitingPostoperative Pain Management | Coronary Artery Bypass Grafting (CABG) Surgery | Coronary Arterial DiseaseTurkey (Türkiye)