Treatment for Percutaneous Nephrolithotomy (PNL)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Tennessee Medical Center, Knoxville, TN
Percutaneous Nephrolithotomy (PNL)
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether an ESP block can reduce the amount of morphine needed after a percutaneous nephrolithotomy.

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 5 secondary outcomes in patients with Percutaneous Nephrolithotomy (PNL). Measurement will happen over the course of First 24 hours after surgery..

24 hours
Opioid use during first 24 hours after surgery
Day 30
QoR-15
30 days
Opioid use during 30 days post hospital discharge
Hour 24
VAS score
First 24 hours postoperative
Opioid consumption (MME)
Day 30
Hospital LOS

Trial Safety

Trial Design

2 Treatment Groups

ESP Group
1 of 2
Sham Group
1 of 2
Active Control
Non-Treatment Group

This trial requires 128 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Sham Group
Procedure
One 30mL syringe containing 30mL of preservative free normal saline
ESP GroupOne 30mL syringe containing 30mL of 0.5% ropivacaine and 4 mg of dexamethosone-

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: number of days in hospital (inpatient) from day of surgery (day 1) until discharge post-surgery in 24 hour increments up to 30 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly number of days in hospital (inpatient) from day of surgery (day 1) until discharge post-surgery in 24 hour increments up to 30 days for reporting.

Closest Location

University of Tennessee Medical Center - Knoxville, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.

Patient Q&A Section

Can percutaneous nephrolithotomy (pnl) be cured?

"The cure rate for SWL appears to be around 70% although one-third of patients require a series of interventions over their lifetime in order to manage the stone disease, although in most cases pNL can solve a significant percentage of patients' problems. pNL is a safe, minimally invasive procedure which should be offered as first line therapy for patients who will require an important degree of intervention." - Anonymous Online Contributor

Unverified Answer

What are the signs of percutaneous nephrolithotomy (pnl)?

"It is crucial to correctly diagnose and recognize any of the possible complications during PCNL. This is to prevent the occurrence of major complications like septic infections. This way of diagnosing and recognizing these complications will help manage the situation in a more better way. The signs of PCNL as stated by surgeons are as follows: swelling in the upper abdominal region, decreased urine output, severe abdominal pain, severe discomfort, loss of urine and blood volume after operative discharge. It can also lead to damage to the renal and urinary tract." - Anonymous Online Contributor

Unverified Answer

How many people get percutaneous nephrolithotomy (pnl) a year in the United States?

"Although nephrolithotomy procedures accounted for approximately one-third of all urological services rendered in US hospitals annually, they remain a high-volume procedure, particularly in patients under the age of 60 years." - Anonymous Online Contributor

Unverified Answer

What is percutaneous nephrolithotomy (pnl)?

"PNL results are similar to open pyelolithotomy (OPNL) in terms of complication rates. However, it has fewer inpatient stay and hospitalization costs. PNL can be an effective and safe option of treating upper tract benign and malignant urolithiasis." - Anonymous Online Contributor

Unverified Answer

What causes percutaneous nephrolithotomy (pnl)?

"PNL may be one of the most effective procedures available for the treatment of large calyceal stones. It is a safe and effective treatment provided that appropriate care and a full stone work-up is performed before the procedure. The complication rate is low because of effective intraoperative and postoperative care and adequate expertise." - Anonymous Online Contributor

Unverified Answer

What are common treatments for percutaneous nephrolithotomy (pnl)?

"The majority of patients undergoing PCNL receive analgesia with IV sedation. Some also receive procedural sedation. Most PCNLs are performed under spinal analgesia. However, opioid analgesia is used in almost 50% of PCNLs. Patient positioning and analgesia are not standardized, although some guidelines have been published. There also appear to be differences between institutions: for example, some have reported using conscious sedation while others do not. The choice of analgesic agents during PCNL can impact short term, intermediate, and long term outcomes." - Anonymous Online Contributor

Unverified Answer

Does percutaneous nephrolithotomy (pnl) run in families?

"In this report, we have shown that a significant number (13%) of patients with PNL require a second procedure. It seems that PNL has a hereditary effect which, on occasion, can be genetically related. This is the first suggestion of a hereditary component in patients with recurrent stone disease. Further work is needed to determine the genetic basis. Results from a recent clinical trial points to the need for a larger cohort to confirm these preliminary findings and to evaluate the contribution of the different factors, namely, genetic, environmental, and behavioural, which appear to control stone-forming tendencies in our patients." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating percutaneous nephrolithotomy (pnl)?

"Recently we have had some new discoveries to treat stone diseases but it will be long time for pnl to be a perfect technique for treating stone diseases." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in treatment for therapeutic use?

"There have been many advances in treatment of stone disease as a result of modern surgery and medical treatment. In the past, patients would have had to undergo surgical stone removal with the open surgical technique. Modern developments in laparoscopic kidney stone surgery have allowed minimally invasive surgery. This is the case for the treatment of kidney stone disease. Today, surgical removal of kidney stones is not only done by minimally invasive surgery techniques, but also with open surgical techniques since kidney stones are hard and very difficult to remove during the laparoscopic surgery. For every surgery that is carried out, it is important that it should be accompanied with proper follow up by a specialist to ensure that it is successful and that there are no complications." - Anonymous Online Contributor

Unverified Answer

What is treatment?

"It is highly important for patients with urinary calculi treated by pnl to recognize the urgency of treatment and consider a conservative approach if necessary for symptomatic relief. There is a lack of consensus and controversy as to whether surgical treatment is appropriate or not during the postoperative period following pnl. This uncertainty could affect the decision to receive immediate treatment postoperatively, which could be based on the degree of pain. The potential need for pnl with conservative treatment in place of immediate surgical treatment should be reconsidered." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets percutaneous nephrolithotomy (pnl)?

"When analyzing the demographics, we should be thinking in terms of demographics rather than looking at specific diagnoses, like stone disease alone. We expect that younger patients are more likely to have complications. We find many patients that do not have stones, and yet are managed in the way that if they were a stone disease sufferer. We expect that older patients may not have stones, but instead be treated for different reasons. We expect that women will tend to be older than men. Older age is associated with higher risks of complications. We expect that blacks and Hispanics will have much higher complication rates." - Anonymous Online Contributor

Unverified Answer

How does treatment work?

"In addition to the stone fragments, the patient is also exposed to a variety of medications to treat the symptoms of stone disease. It is essential to understand that the most important factor in the success of PCNL is to choose the most appropriate treatment for the specific situation at the time of treatment by a qualified health care professional. The outcome for patients treated surgically for renal stones in the United States is very good. Patients with larger stones (> or = 4 cm) or those with additional complications (kidney stones in the lower flank or in the lower flank and renal colic) have an increased risk of treatment failure." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Percutaneous Nephrolithotomy (PNL) by sharing your contact details with the study coordinator.