Postoperative PainNCT07721571
Nephrostomy Tract Infiltration for Pain Control After PCNL
A study testing Bupivacaine and Intravenous Tramadol and Paracetamol in people with Postoperative Pain and Kidney Calculi, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, controlled clinical trial aims to evaluate the effectiveness of nephrostomy tract local anesthetic infiltration for postoperative pain control in patients undergoing prone percutaneous nephrolithotomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain, Kidney Calculi
- What is being tested?
- Bupivacaine and Intravenous Tramadol and Paracetamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jul 2026to 11 Jun 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 75 years
- Scheduled to undergo elective percutaneous nephrolithotomy in the prone position
- Classified as American Society of Anesthesiologists (ASA) physical status I-III
- Able to understand and complete postoperative pain assessments using the Visual Analog Scale (VAS)
- Willing to participate in the study
- Provision of written informed consent
Who cannot join
- Known allergy or hypersensitivity to bupivacaine or other local anesthetic agents
- Coagulopathy or clinically significant bleeding disorder
- Chronic opioid use
- History of a neurological disorder that may affect pain perception or assessment
- Neurological or psychiatric condition preventing reliable postoperative pain assessment
- Active urinary tract infection or sepsis
Show all 11Show fewer
- American Society of Anesthesiologists (ASA) physical status IV or higher
- Requirement for multiple percutaneous access tracts
- Bilateral percutaneous nephrolithotomy
- Requirement for postoperative intensive care
- Refusal or inability to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye
Çorum, Çorum, 19040
MUSA EKİCİ, +90 505 751 6341, musaekici@hitit.edu.tr
AHMET TAŞCI
About this study
Official title: Efficacy of Nephrostomy Tract Local Anesthetic Infiltration for Postoperative Pain Control Following Prone Percutaneous Nephrolithotomy: A Prospective Randomized Controlled Trial
This prospective, randomized, controlled clinical trial aims to evaluate the effectiveness of nephrostomy tract local anesthetic infiltration for postoperative pain control in patients undergoing prone percutaneous nephrolithotomy. Eligible patients will be randomly assigned to either a control group receiving standard systemic postoperative analgesia or an intervention group receiving standard analgesia plus infiltration of 20 mL of 0.25% bupivacaine along the nephrostomy tract at the end of surgery. Postoperative pain will be assessed using the Visual Analog Scale at 1, 6, 12, and 24 hours. Secondary outcomes will include time to first analgesic requirement, total opioid consumption during the first 24 hours, need for rescue analgesia, time to mobilization, length of hospital stay, and treatment-related complications. The study is designed to determine whether nephrostomy tract infiltration provides a simple, safe, and effective adjunct for reducing pain and analgesic consumption after percutaneous nephrolithotomy.
- Conditions
- Postoperative Pain, Kidney Calculi
- Being tested
- Bupivacaine, Intravenous Tramadol and Paracetamol
- Keywords
- local anesthetic infiltration, Percutaneous nephrolithotomy, peritubal infiltration, postoperative pain
- Medical subject headings
- Pain, Postoperative, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Bupivacaine hydrochloride, Nephrostomy tract local anesthetic infiltration, Peritubal bupivacaine infiltration
A total of 20 mL of 0.25% bupivacaine will be administered by local infiltration along the nephrostomy tract at the end of surgery. The infiltration will include the skin, subcutaneous tissue, muscular layers, and tissues surrounding the nephrostomy tract.
Intravenous Tramadol and ParacetamolDrug
Also called Standard postoperative analgesia, Intravenous tramadol and acetaminophen
Standard postoperative systemic analgesia consisting of intravenous tramadol and intravenous paracetamol will be administered according to the institutional analgesia protocol. Rescue opioid analgesia will be provided when clinically required.
| Study group | Role | What they receive |
|---|---|---|
| Nephrostomy Tract Bupivacaine Infiltration | Experimental | Participants in this arm will receive standard postoperative systemic analgesia. In addition, at the end of percutaneous nephrolithotomy, 20 mL of 0.25% bupivacaine will be infiltrated along the nephrostomy tract, including the skin, subcutaneous tissue, muscular layers, and tissues surrounding the nephrostomy tract. Receives: Drug: Bupivacaine; Drug: Intravenous Tramadol and Paracetamol |
| Standard Systemic Analgesia | Active comparator | Participants in this arm will receive the standard postoperative systemic analgesia protocol, including intravenous tramadol and intravenous paracetamol. Rescue opioid analgesia will be administered when clinically required. No local or regional analgesic intervention will be performed. Receives: Drug: Intravenous Tramadol and Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity Assessed Using the Visual Analog Scale
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS). Patients will rate their pain on a scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. VAS scores will be compared between the nephrostomy tract bupivacaine infiltration group and the standard systemic analgesia group.
Measured: At 1, 6, 12, and 24 hours after surgery
Secondary outcomes (3)
Time to First Rescue Analgesic Requirement
The time from the end of surgery to the first administration of rescue analgesic medication will be recorded in minutes. A longer duration indicates a prolonged postoperative analgesic effect.
Measured: From the end of surgery until the first rescue analgesic administration, within the first 24 postoperative hours
Total Opioid Consumption During the First 24 Postoperative Hours
The total amount of opioid analgesics administered during the first 24 hours after surgery will be recorded. When different opioid agents are used, doses will be converted to intravenous morphine milligram equivalents for comparison between groups.
Measured: During the first 24 hours after surgery
Requirement for Rescue Analgesia
The number and proportion of participants requiring at least one dose of rescue analgesic medication will be compared between the study groups.
Measured: During the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start17 Jul 2026
- Primary completion11 Jan 2027 (estimated)
- Study completion11 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Serdar CAGLAYAN, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721571
- Sponsor's protocol ID
- ETIK-2026-28
- Status last verified
- Jul 2026
- First submitted
- 18 Jul 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shah HN, Shah RH, Sodha HS, Khandkar AA, Gokhale A. A randomized control trial evaluating efficacy of nephrostomy tract infiltration with bupivacaine after tubeless percutaneous nephrolithotomy. J Endourol. 2012 May;26(5):478-83. doi: 10.1089/end.2011.0465. Epub 2011 Dec 22.
PubMed 22191494Arshad Z, Zaidi SZ, Jamshaid A, Qureshi AH. Post operative pain control in percutaneous nephrolithotomy. J Pak Med Assoc. 2018 May;68(5):702-704.
PubMed 29885165
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nephrostomy Tract Local Anesthetic Infiltration for Postoperative Pain Control Following Prone Percutaneous Nephrolithotomy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07721571
- Acronym / sponsor ID
- ETIK-2026-28
- Conditions
- Postoperative Pain, Kidney Calculi
- Keywords
- local anesthetic infiltration, Percutaneous nephrolithotomy, peritubal infiltration, postoperative pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- 11 Jan 2027 (estimated)
- Study completion
- 11 Jun 2027 (estimated)
- First posted
- 23 Jul 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.
This prospective, randomized, controlled clinical trial aims to evaluate the effectiveness of nephrostomy tract local anesthetic infiltration for postoperative pain control in patients undergoing prone percutaneous nephrolithotomy. Eligible patients will be randomly assigned to either a control group receiving standard systemic postoperative analgesia or an intervention group receiving standard analgesia plus infiltration of 20 mL of 0.25% bupivacaine along the nephrostomy tract at the end of surgery. Postoperative pain will be assessed using the Visual Analog Scale at 1, 6, 12, and 24 hours. Secondary outcomes will include time to first analgesic requirement, total opioid consumption during the first 24 hours, need for rescue analgesia, time to mobilization, length of hospital stay, and treatment-related complications. The study is designed to determine whether nephrostomy tract infiltration provides a simple, safe, and effective adjunct for reducing pain and analgesic consumption after percutaneous nephrolithotomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nephrostomy Tract Bupivacaine Infiltration | Experimental | Drug: Bupivacaine, Drug: Intravenous Tramadol and ParacetamolParticipants in this arm will receive standard postoperative systemic analgesia. In addition, at the end of percutaneous nephrolithotomy, 20 mL of 0.25% bupivacaine will be infiltrated along the nephrostomy tract, including the skin, subcutaneous tissue, muscular layers, and tissues surrounding the nephrostomy tract. |
| Standard Systemic Analgesia | Active comparator | Drug: Intravenous Tramadol and ParacetamolParticipants in this arm will receive the standard postoperative systemic analgesia protocol, including intravenous tramadol and intravenous paracetamol. Rescue opioid analgesia will be administered when clinically required. No local or regional analgesic intervention will be performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 to 75 years
- Scheduled to undergo elective percutaneous nephrolithotomy in the prone position
- Classified as American Society of Anesthesiologists (ASA) physical status I-III
- Able to understand and complete postoperative pain assessments using the Visual Analog Scale (VAS)
- Willing to participate in the study
Key exclusion criteria (11 listed)
- Known allergy or hypersensitivity to bupivacaine or other local anesthetic agents
- Coagulopathy or clinically significant bleeding disorder
- Chronic opioid use
- History of a neurological disorder that may affect pain perception or assessment
- Neurological or psychiatric condition preventing reliable postoperative pain assessment
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 |
|---|---|---|
| BupivacaineAlso: Bupivacaine hydrochloride, Nephrostomy tract local anesthetic infiltration, Peritubal bupivacaine infiltrationA total of 20 mL of 0.25% bupivacaine will be administered by local infiltration along the nephrostomy tract at the end of surgery. The infiltration will include the skin, subcutaneous tissue, muscular layers, and tissues surrounding the nephrostomy tract. | Drug | Nephrostomy Tract Bupivacaine Infiltration |
| Intravenous Tramadol and ParacetamolAlso: Standard postoperative analgesia, Intravenous tramadol and acetaminophenStandard postoperative systemic analgesia consisting of intravenous tramadol and intravenous paracetamol will be administered according to the institutional analgesia protocol. Rescue opioid analgesia will be provided when clinically required. | Drug | Nephrostomy Tract Bupivacaine Infiltration, Standard Systemic Analgesia |
Primary outcome
Postoperative Pain Intensity Assessed Using the Visual Analog Scale
Time frame: At 1, 6, 12, and 24 hours after surgery
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS). Patients will rate their pain on a scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. VAS scores will be compared between the nephrostomy tract bupivacaine infiltration group and the standard systemic analgesia group.
3 secondary outcomes
Time to First Rescue Analgesic Requirement
Time frame: From the end of surgery until the first rescue analgesic administration, within the first 24 postoperative hours
Total Opioid Consumption During the First 24 Postoperative Hours
Time frame: During the first 24 hours after surgery
Requirement for Rescue Analgesia
Time frame: 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 6 Oct 2026.
- Background: PubMed 22191494Shah HN, Shah RH, Sodha HS, Khandkar AA, Gokhale A. A randomized control trial evaluating efficacy of nephrostomy tract infiltration with bupivacaine after tubeless percutaneous nephrolithotomy. J Endourol. 2012 May;26(5):478-83. doi: 10.1089/end.2011.0465. Epub 2011 Dec 22.
- Background: PubMed 29885165Arshad Z, Zaidi SZ, Jamshaid A, Qureshi AH. Post operative pain control in percutaneous nephrolithotomy. J Pak Med Assoc. 2018 May;68(5):702-704.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine and Intravenous Tramadol and Paracetamol in people with Postoperative Pain and Kidney Calculi, run by Hitit University at 1 site in Turkey (Türkiye).
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 6 inclusion and 11 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 6 Oct 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 Turkey (Türkiye). 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?
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 MUSTAFA SERDAR ÇAĞLAYAN (+905074311951, serdar.09.09@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity Assessed Using the Visual Analog Scale (time frame: At 1, 6, 12, and 24 hours after surgery). 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 NCT07721571, which also lists 2 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 6 Oct 2026.