Nephrostomy Tract Infiltration for Pain Control After PCNL

NCT07721571 | Recruiting DMC

• 1 other identifier: ETIK-2026-28
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

local anesthetic infiltration; Percutaneous nephrolithotomy; peritubal infiltration; postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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.

  At 1, 6, 12, and 24 hours after surgery

Secondary Outcomes (3)

• Time to First Rescue Analgesic Requirement

  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

  During the first 24 hours after surgery

• Requirement for Rescue Analgesia

  During the first 24 hours after surgery

Study Arms (2)

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.

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.

Drug: Intravenous Tramadol and Paracetamol

Interventions

Bupivacaine DRUG

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.

Also known as: Bupivacaine hydrochloride, Nephrostomy tract local anesthetic infiltration, Peritubal bupivacaine infiltration

Nephrostomy Tract Bupivacaine Infiltration

Intravenous Tramadol and Paracetamol DRUG

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.

Also known as: Standard postoperative analgesia, Intravenous tramadol and acetaminophen

Nephrostomy Tract Bupivacaine Infiltration; Standard Systemic Analgesia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 75 years
• Scheduled to undergo elective percutaneous nephrolithotomy in the prone position
• Classified as American Society of Anesthesiologists physical status I-III
• Able to understand and complete postoperative pain assessments using the Visual Analog Scale
• Willing to participate in the study
• Provision of written informed consent

You may not qualify if:

• 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 American Society of Anesthesiologists 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

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye

Çorum, Çorum, 19040, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 22191494 BACKGROUND

• Arshad Z, Zaidi SZ, Jamshaid A, Qureshi AH. Post operative pain control in percutaneous nephrolithotomy. J Pak Med Assoc. 2018 May;68(5):702-704.

  PMID: 29885165 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Kidney Calculi

Interventions

Bupivacaine; Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides

Central Study Contacts

MUSTAFA SERDAR ÇAĞLAYAN

CONTACT

+905074311951; serdar.09.09@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, MD

Study Record Dates

• First Submitted: July 18, 2026
• First Posted: July 23, 2026
• Study Start: July 17, 2026
• Primary Completion (Estimated): January 11, 2027
• Study Completion (Estimated): June 11, 2027
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)