A randomized control trial evaluating efficacy of nephrostomy tract infiltration with bupivacaine after tubeless percutaneous nephrolithotomy.
Hemendra N Shah, Rashmi H Shah, Hiren S Sodha...
https://pubmed.ncbi.nlm.nih.gov/22191494/Actively Recruiting
Led by Hitit University · Updated on 2026-07-23
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
Researchers are assessing the effectiveness of using local anesthetic infiltration along the nephrostomy tract to control pain after prone percutaneous nephrolithotomy surgery. This randomized controlled trial compares standard systemic postoperative pain treatment alone versus standard treatment combined with infiltration of 20 mL of 0.25% bupivacaine. The goal is to find out if this local infiltration reduces pain and the need for additional pain medication after surgery. Participants will be randomly assigned to one of two groups. One group will receive standard postoperative pain relief with intravenous tramadol and paracetamol, while the other group will receive the same systemic analgesia plus local infiltration of bupivacaine along the nephrostomy tract at the end of surgery. Rescue opioid analgesia is available if needed for both groups. The study tracks outcomes during the first 24 hours after surgery. Participants will have their pain levels measured using the Visual Analog Scale at 1, 6, 12, and 24 hours post-surgery. Additional assessments include time to first need for rescue analgesia, total opioid use in 24 hours, need for rescue analgesia, time to mobilization, length of hospital stay, and any treatment-related complications. The study lasts through the immediate postoperative period with close monitoring of pain and recovery indicators.
CONDITIONS
Nephrostomy Tract Infiltration for Pain Control After PCNL
M
MUSTAFA SERDAR ÇAĞLAYAN
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Hitit University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 hours post-surgery
Participants undergo prone percutaneous nephrolithotomy surgery and receive either standard systemic analgesia alone or with local bupivacaine infiltration along the nephrostomy tract at surgery end.
Pain assessments at 1, 6, 12, and 24 hours after surgery
Duration - Up to 24 hours after surgery
Researchers monitor pain intensity, opioid use, time to first analgesic, mobilization time, hospital stay length, and any treatment-related complications during the first 24 hours after surgery.
Regular monitoring during hospital stay
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Hemendra N Shah, Rashmi H Shah, Hiren S Sodha...
https://pubmed.ncbi.nlm.nih.gov/22191494/Zeeshan Arshad, Syed Zafar Zaidi, Anila Jamshaid...
https://pubmed.ncbi.nlm.nih.gov/29885165/Hitit University
Lead Sponsor