Nephrolithotomy, PercutaneousNCT05024344
ESP Block vs Control for Pain Control Following Percutaneous Nephrolithotomy
A study testing Erector Spinae Plane Block, Ropivacaine 0.5% Injectable Solution and Dexamethasone in people with Nephrolithotomy, Percutaneous, run by University of Tennessee Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate the use of the erector spinae (ESP) block in reducing the morphine milligram equivalent (MME) consumption post percutaneous nephrolithotomy. Objectives: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithotomy, Percutaneous
- What is being tested?
- Erector Spinae Plane Block, Ropivacaine 0.5% Injectable Solution and Dexamethasone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2021to 30 Jun 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, male and female greater than or equal to 18 years of age and undergoing non-emergent percutaneous nephrolithotomy Monday through Friday between the hours of 6:00AM and 4:00PM.
- Female participants of childbearing potential will be required to provide a negative pregnancy test.
- Ability to understand and teach back consent for the procedure.
- Willingness to sign consent for procedure.
- English speaking.
Who cannot join
- Emergent surgery status.
- Local infection
- Allergy to local anesthetics.
- Recreational drug use.
- Inability to provide informed consent.
- Pregnancy or breastfeeding.
Show all 9Show fewer
- History of Guillain-Barre' Syndrome.
- Underlying medical conditions that would post a significant risk to the patient.
- Opioid use >90 days in the year leading up to surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Aimee Pehrson, 865-305-5432, apehrson@utmck.edu
About this study
Official title: Erector Spinae Plane Block Versus Control for Pain Control Following Percutaneous Nephrolithotomy: A Randomized, Double-Blind, Placebo Controlled Study
The purpose of this study is to investigate the use of the erector spinae (ESP) block in reducing the morphine milligram equivalent (MME) consumption post percutaneous nephrolithotomy. Objectives:
- - Determine if there is a significant effect on post percutaneous nephrolithotomy MME consumption with the usage of an ESP block vs. saline control.
- - Determine if there is a significant effect on reported pain levels with the use of an ESP block vs. saline control in post percutaneous nephrolithotomies.
Read the detailed description
This is a double-blind, randomized control trial involving 128 subjects undergoing an elective percutaneous nephrolithotomy. All subjects who meet all inclusion and exclusion criteria will be equally randomized on the day of the procedure by operating room pharmacy into either the ESP block or the control block. An interim analysis at the sample size required for a large effect size (n = 52, with n = 26 in each treatment arm) will be performed. In order to blind the anesthesiologist performing the block, the control arm will be equally randomized by the pharmacist at the time of distributing the pre-filled syringes for the ESP block procedure. Randomization will occur with the use of a random number generator with 1:1 ESP:Control allocation ratio.
Subjects will be followed at Pre-op and the 24-h, 48-h, 7 days and 30 days post operatively to assess the quality of recovery utilizing the Quality of Recovery-15 (QoR-15) questionnaire, VAS pain scale, and opioid consumption. Intraoperative MMEs, PACU MMEs, total MME's, FLACC scores at 30 minutes/1 hour VAS scores at 1 hour/2 hours/6 hours/24 hours, PACU LOS, hospital LOS, time to first flatus will be documented in patient chart, reviewed by study personnel and uploaded into a password protected database on the UTMCK server.
All aspects of the study and consent forms will be IRB approved prior to implementation. Potential candidates will be selected for consent based on chart review and surgery scheduling.
- The Surgeon will initially approach potential subjects and provide them with a copy of the consent form to take home and read prior to pre-anesthesia testing.
- At the subject's pre-anesthesia testing appointment, the research staff will explain the risks and benefits of the study, answer any questions, and obtain consent to participate.
- The Biostatistician will randomize the subjects with a random number generator. Once randomized, a blinded package labeled "ESP" or "Control" will be delivered to the regional anesthesia team containing the following:
ESP
Active group:
- One 30mL syringe containing 29mL of 0.5% ropivacaine and 4mg of dexamethasone- labeled "ESP Block"
- One 30mL syringe containing 30mL of preservative free normal saline- labeled "wound infiltration" Sham group
- One 30mL syringe containing 30mL of 0.5% ropivacaine- labeled "wound infiltration" 2. One 30mL syringe containing 30mL of preservative free normal saline- labeled "ESP Block"
- The pharmacist will create a table pre-populated with the randomization assignments with space to fill out patient information and medication information on the day of surgery. This chart will be in paper form and kept in a research binder in the OR pharmacy. When a patient is consented for the RCT, the treatment group will be chosen based on the numbers assigned a priori. Each qualifying patient will be documented on the subsequent row in the table, maintaining the original order of randomization as dictated by the statistician. Based on the assignment, the pharmacy technician will be instructed as to which products to make in the sterile hood. The pharmacist will verify that the products were made appropriately and will label the syringes according to assignment.
- Operating room pharmacy will hand the anesthesiologist a blinded package with one prefilled syringe for the regional block that will either contain 30mL of 0.5% ropivacaine with 4mg of dexamethasone or preservative free normal saline.
- The regional anesthesiologist will perform the ESP block using standard protocols and procedures.
- Age, BMI, duration of operation, EBL, intraoperative MMEs, PACU MMEs, 48 hours post-operative MMEs, total MME's, FLACC scores at 30 minutes/1 hour VAS scores at 1 hour/2 hours/6 hours/24 hours, PACU LOS, hospital LOS, time to first flatus will be documented in patient chart and reviewed by study personnel.
- QoR-15, MME consumption, and VAS will be assessed at Pre-op, 24-h, 48-h, 7 and 30 days by study staff. Data will be uploaded into a database kept on secured password protected computers on the UTMCK server.
- All patient identifiers will be removed prior to data analysis.
- Conditions
- Nephrolithotomy, Percutaneous
- Being tested
- Erector Spinae Plane Block, Ropivacaine 0.5% Injectable Solution, Dexamethasone
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
The Anesthesiologist will use ultrasound-guided technique and inject 30mL of 0.5% ropivacaine with 4 mg of dexamethasone or saline placebo control into the erector spinae muscle, superficial to the tips of the thoracic transverse processes
Ropivacaine 0.5% Injectable SolutionDrug
The Anesthesiologist will use ultrasound-guided technique and inject 30mL of 0.5% ropivacaine with 4 mg of dexamethasone or saline placebo control into the erector spinae muscle, superficial to the tips of the thoracic transverse processes
DexamethasoneDrug
The Anesthesiologist will use ultrasound-guided technique and inject 30mL of 0.5% ropivacaine with 4 mg of dexamethasone or saline placebo control into the erector spinae muscle, superficial to the tips of the thoracic transverse processes
| Study group | Role | What they receive |
|---|---|---|
| ESP Group | Active comparator | One 30mL syringe containing 30mL of 0.5% ropivacaine and 4 mg of dexamethosone- Receives: Procedure: Erector Spinae Plane Block; Drug: Ropivacaine 0.5% Injectable Solution; Drug: Dexamethasone |
| Sham Group | Sham comparator | One 30mL syringe containing 30mL of preservative free normal saline Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption (MME)
Opioid consumption (MME) in the first 24 hours postoperative
Measured: First 24 hours postoperative
Secondary outcomes (5)
Hospital LOS
Hospital length of stay
Measured: Number of days in hospital (inpatient) from day of surgery (day 1) until discharge post-surgery in 24 hour increments up to 30 days
VAS score
Mean Visual Analog Scale (VAS) score in the first 24 hours after surgery. VAS measures the amount of pain that a patient feels ranging across a continuum from none(0) to an extreme amount of pain(10) on a chart.
Measured: First 24 hours after surgery.
Opioid use during first 24 hours after surgery
MMEs (morphine milligram equivalent) administered during first 24 hours post surgery
Measured: 24 hours
QoR-15
Quality of Recovery -15 at 24 hours, 48 hours, 7 days, and 30 days after surgery. QoR-15 measures how a patient feels they are recovering after surgery using a 15 item survey rated 0 (none of the time-poor) to 10 (all of the time-excellent).
Measured: 24 hours, 48 hours, 7 days, and 30 days after surgery
Opioid use during 30 days post hospital discharge
MMEs administered/consumed during 30 day period post hospital discharge
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start9 Aug 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Nephrolithotomy, PercutaneousStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Buehler, MD, Principal investigator, University of Tennessee Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024344
- Sponsor's protocol ID
- ANES-01-072021
- Status last verified
- Apr 2026
- First submitted
- 2 Aug 2021
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dundar G, Gokcen K, Gokce G, Gultekin EY. The Effect of Local Anesthetic Agent Infiltration Around Nephrostomy Tract On Postoperative Pain Control After Percutaneous Nephrolithotomy: A single-centre, randomised, double-blind, placebocontrolled clinical trial. Urol J. 2018 Nov 17;15(6):306-312. doi: 10.22037/uj.v0i0.4145.
PubMed 29681047De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4.
PubMed 30621377Tulgar S, Selvi O, Ozer Z. Clinical experience of ultrasound-guided single and bi-level erector spinae plane block for postoperative analgesia in patients undergoing thoracotomy. J Clin Anesth. 2018 Nov;50:22-23. doi: 10.1016/j.jclinane.2018.06.034. Epub 2018 Jun 23. No abstract available.
PubMed 29940470Kwon WJ, Bang SU, Sun WY. Erector Spinae Plane Block for Effective Analgesia after Total Mastectomy with Sentinel or Axillary Lymph Node Dissection: a Report of Three Cases. J Korean Med Sci. 2018 Nov 5;33(45):e291. doi: 10.3346/jkms.2018.33.e291. No abstract available.
PubMed 31044575Ibrahim M, Elnabtity AM. Analgesic efficacy of erector spinae plane block in percutaneous nephrolithotomy : A randomized controlled trial. Anaesthesist. 2019 Nov;68(11):755-761. doi: 10.1007/s00101-019-00673-w. Epub 2019 Oct 16.
PubMed 31620856Govender S, Mohr D, Van Schoor AN, Bosenberg A. The extent of cranio-caudal spread within the erector spinae fascial plane space using computed tomography scanning in a neonatal cadaver. Paediatr Anaesth. 2020 Jun;30(6):667-670. doi: 10.1111/pan.13864. Epub 2020 Apr 22.
PubMed 32267041Ugras MY, Toprak HI, Gunen H, Yucel A, Gunes A. Instillation of skin, nephrostomy tract, and renal puncture site with ropivacaine decreases pain and improves ventilatory function after percutaneous nephrolithotomy. J Endourol. 2007 May;21(5):499-503. doi: 10.1089/end.2006.0335.
PubMed 17523902Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
PubMed 30292068
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block Versus Control for Pain Control Following Percutaneous Nephrolithotomy: A Randomized, Double-Blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT05024344
- Acronym / sponsor ID
- ANES-01-072021
- Conditions
- Nephrolithotomy, Percutaneous
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of Tennessee Medical CenterUniversity, hospital or other
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 27 Aug 2021 (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 purpose of this study is to investigate the use of the erector spinae (ESP) block in reducing the morphine milligram equivalent (MME) consumption post percutaneous nephrolithotomy. Objectives:
- - Determine if there is a significant effect on post percutaneous nephrolithotomy MME consumption with the usage of an ESP block vs. saline control.
- - Determine if there is a significant effect on reported pain levels with the use of an ESP block vs. saline control in post percutaneous nephrolithotomies.
Detailed description
This is a double-blind, randomized control trial involving 128 subjects undergoing an elective percutaneous nephrolithotomy. All subjects who meet all inclusion and exclusion criteria will be equally randomized on the day of the procedure by operating room pharmacy into either the ESP block or the control block. An interim analysis at the sample size required for a large effect size (n = 52, with n = 26 in each treatment arm) will be performed. In order to blind the anesthesiologist performing the block, the control arm will be equally randomized by the pharmacist at the time of distributing the pre-filled syringes for the ESP block procedure. Randomization will occur with the use of a random number generator with 1:1 ESP:Control allocation ratio.
Subjects will be followed at Pre-op and the 24-h, 48-h, 7 days and 30 days post operatively to assess the quality of recovery utilizing the Quality of Recovery-15 (QoR-15) questionnaire, VAS pain scale, and opioid consumption. Intraoperative MMEs, PACU MMEs, total MME's, FLACC scores at 30 minutes/1 hour VAS scores at 1 hour/2 hours/6 hours/24 hours, PACU LOS, hospital LOS, time to first flatus will be documented in patient chart, reviewed by study personnel and uploaded into a password protected database on the UTMCK server.
All aspects of the study and consent forms will be IRB approved prior to implementation. Potential candidates will be selected for consent based on chart review and surgery scheduling.
- The Surgeon will initially approach potential subjects and provide them with a copy of the consent form to take home and read prior to pre-anesthesia testing.
- At the subject's pre-anesthesia testing appointment, the research staff will explain the risks and benefits of the study, answer any questions, and obtain consent to participate.
- The Biostatistician will randomize the subjects with a random number generator. Once randomized, a blinded package labeled "ESP" or "Control" will be delivered to the regional anesthesia team containing the following:
ESP
Active group:
- One 30mL syringe containing 29mL of 0.5% ropivacaine and 4mg of dexamethasone- labeled "ESP Block"
- One 30mL syringe containing 30mL of preservative free normal saline- labeled "wound infiltration" Sham group
- One 30mL syringe containing 30mL of 0.5% ropivacaine- labeled "wound infiltration" 2. One 30mL syringe containing 30mL of preservative free normal saline- labeled "ESP Block"
- The pharmacist will create a table pre-populated with the randomization assignments with space to fill out patient information and medication information on the day of surgery. This chart will be in paper form and kept in a research binder in the OR pharmacy. When a patient is consented for the RCT, the treatment group will be chosen based on the numbers assigned a priori. Each qualifying patient will be documented on the subsequent row in the table, maintaining the original order of randomization as dictated by the statistician. Based on the assignment, the pharmacy technician will be instructed as to which products to make in the sterile hood. The pharmacist will verify that the products were made appropriately and will label the syringes according to assignment.
- Operating room pharmacy will hand the anesthesiologist a blinded package with one prefilled syringe for the regional block that will either contain 30mL of 0.5% ropivacaine with 4mg of dexamethasone or preservative free normal saline.
- The regional anesthesiologist will perform the ESP block using standard protocols and procedures.
- Age, BMI, duration of operation, EBL, intraoperative MMEs, PACU MMEs, 48 hours post-operative MMEs, total MME's, FLACC scores at 30 minutes/1 hour VAS scores at 1 hour/2 hours/6 hours/24 hours, PACU LOS, hospital LOS, time to first flatus will be documented in patient chart and reviewed by study personnel.
- QoR-15, MME consumption, and VAS will be assessed at Pre-op, 24-h, 48-h, 7 and 30 days by study staff. Data will be uploaded into a database kept on secured password protected computers on the UTMCK server.
- All patient identifiers will be removed prior to data analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP Group | Active comparator | Procedure: Erector Spinae Plane Block, Drug: Ropivacaine 0.5% Injectable Solution, Drug: DexamethasoneOne 30mL syringe containing 30mL of 0.5% ropivacaine and 4 mg of dexamethosone- |
| Sham Group | Sham comparator | Procedure: Erector Spinae Plane BlockOne 30mL syringe containing 30mL of preservative free normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults, male and female greater than or equal to 18 years of age and undergoing non-emergent percutaneous nephrolithotomy Monday through Friday between the hours of 6:00AM and 4:00PM.
- Female participants of childbearing potential will be required to provide a negative pregnancy test.
- Ability to understand and teach back consent for the procedure.
- Willingness to sign consent for procedure.
- English speaking.
Key exclusion criteria (9 listed)
- Emergent surgery status.
- Local infection
- Allergy to local anesthetics.
- Recreational drug use.
- Inability to provide informed consent.
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 BlockThe Anesthesiologist will use ultrasound-guided technique and inject 30mL of 0.5% ropivacaine with 4 mg of dexamethasone or saline placebo control into the erector spinae muscle, superficial to the tips of the thoracic transverse processes | Procedure or surgery | ESP Group, Sham Group |
| Ropivacaine 0.5% Injectable SolutionThe Anesthesiologist will use ultrasound-guided technique and inject 30mL of 0.5% ropivacaine with 4 mg of dexamethasone or saline placebo control into the erector spinae muscle, superficial to the tips of the thoracic transverse processes | Drug | ESP Group |
| DexamethasoneThe Anesthesiologist will use ultrasound-guided technique and inject 30mL of 0.5% ropivacaine with 4 mg of dexamethasone or saline placebo control into the erector spinae muscle, superficial to the tips of the thoracic transverse processes | Drug | ESP Group |
Primary outcome
Opioid consumption (MME)
Time frame: First 24 hours postoperative
Opioid consumption (MME) in the first 24 hours postoperative
5 secondary outcomes
Hospital LOS
Time frame: Number of days in hospital (inpatient) from day of surgery (day 1) until discharge post-surgery in 24 hour increments up to 30 days
VAS score
Time frame: First 24 hours after surgery.
Opioid use during first 24 hours after surgery
Time frame: 24 hours
QoR-15
Time frame: 24 hours, 48 hours, 7 days, and 30 days after surgery
Opioid use during 30 days post hospital discharge
Time frame: 30 days
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 28 Apr 2026.
- Background: PubMed 29681047Dundar G, Gokcen K, Gokce G, Gultekin EY. The Effect of Local Anesthetic Agent Infiltration Around Nephrostomy Tract On Postoperative Pain Control After Percutaneous Nephrolithotomy: A single-centre, randomised, double-blind, placebocontrolled clinical trial. Urol J. 2018 Nov 17;15(6):306-312. doi: 10.22037/uj.v0i0.4145.
- Background: PubMed 30621377De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4.
- Background: PubMed 29940470Tulgar S, Selvi O, Ozer Z. Clinical experience of ultrasound-guided single and bi-level erector spinae plane block for postoperative analgesia in patients undergoing thoracotomy. J Clin Anesth. 2018 Nov;50:22-23. doi: 10.1016/j.jclinane.2018.06.034. Epub 2018 Jun 23. No abstract available.
- Background: PubMed 31044575Kwon WJ, Bang SU, Sun WY. Erector Spinae Plane Block for Effective Analgesia after Total Mastectomy with Sentinel or Axillary Lymph Node Dissection: a Report of Three Cases. J Korean Med Sci. 2018 Nov 5;33(45):e291. doi: 10.3346/jkms.2018.33.e291. No abstract available.
- Background: PubMed 31620856Ibrahim M, Elnabtity AM. Analgesic efficacy of erector spinae plane block in percutaneous nephrolithotomy : A randomized controlled trial. Anaesthesist. 2019 Nov;68(11):755-761. doi: 10.1007/s00101-019-00673-w. Epub 2019 Oct 16.
- Background: PubMed 32267041Govender S, Mohr D, Van Schoor AN, Bosenberg A. The extent of cranio-caudal spread within the erector spinae fascial plane space using computed tomography scanning in a neonatal cadaver. Paediatr Anaesth. 2020 Jun;30(6):667-670. doi: 10.1111/pan.13864. Epub 2020 Apr 22.
- Background: PubMed 17523902Ugras MY, Toprak HI, Gunen H, Yucel A, Gunes A. Instillation of skin, nephrostomy tract, and renal puncture site with ropivacaine decreases pain and improves ventilatory function after percutaneous nephrolithotomy. J Endourol. 2007 May;21(5):499-503. doi: 10.1089/end.2006.0335.
- Results publication: PubMed 30292068Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
- Individual participant dataSharing planned: No
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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.
Jason Buehler, MD principal investigator
University of Tennessee Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block, Ropivacaine 0.5% Injectable Solution and Dexamethasone in people with Nephrolithotomy, Percutaneous, run by University of Tennessee Medical Center at 1 site in United States.
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 9 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: looking for participants now, as of the sponsor's last update on 28 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 United States. 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. Some participants in this study may receive a placebo. 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 Jason Buehler, MD (865-305-9220, jbuehler@utmck.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (MME) (time frame: First 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05024344, which also lists 8 linked publications.
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 28 Apr 2026.