Bupivacaine for Kidney Stones

Overseen By Leila Yazdanbakhsh

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Chicago

Disqualifiers: Foley catheterization, Pregnancy, Dialysis, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 31

Duration: Immediate post-operative period

116 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether bupivacaine, a local anesthetic, can reduce pain and urinary symptoms after a kidney stone procedure. Researchers will administer bupivacaine directly into the bladder post-procedure to determine its effectiveness compared to a placebo. Individuals diagnosed with kidney stones and scheduled for a procedure involving ureteral stenting may be suitable candidates for this trial. The aim is to enhance comfort and quality of life after surgery. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that bupivacaine is likely to be safe for humans?

Research has shown that bupivacaine is generally safe and effective for pain relief. One study found that using bupivacaine after kidney surgery effectively managed pain without major safety issues. Patients who received bupivacaine reported less pain compared to those who did not. The treatment did not cause significant side effects, indicating it is a safe option for pain control after certain surgeries. Although this trial is in an early stage, some evidence of safety in humans exists, but more information is needed to fully understand its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for kidney stones, such as shock wave lithotripsy or ureteroscopy, bupivacaine offers a novel approach by focusing on pain relief. Bupivacaine is a local anesthetic that targets nerve signals, potentially providing effective pain management without the need for opioids. Researchers are excited about its ability to alleviate pain directly at the site, which could lead to fewer systemic side effects and a reduced need for narcotics. This could significantly enhance patient comfort and recovery during the often painful process of passing kidney stones.

What evidence suggests that bupivacaine might be an effective treatment for post-operative pain after ureteroscopy?

Research has shown that bupivacaine effectively reduces pain after surgery. In other procedures, patients have reported less pain with bupivacaine use. One study found that applying bupivacaine around the surgical area reduced the need for opioid painkillers in the first 48 hours post-surgery. This trial will test 50 ml of 0.25% bupivacaine for its potential to manage pain after procedures like ureteroscopy for kidney stones. Although few studies have examined bupivacaine use in the bladder post-surgery, its success in other surgeries suggests it could be effective here as well. ^{1 2 4 6 7}

Who Is on the Research Team?

Luke Reynolds, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for individuals undergoing ureteroscopy, a procedure to treat kidney stones. Participants should be those who are scheduled for this surgery and can provide informed consent. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

I am diagnosed with kidney stones and scheduled for a specific procedure with stenting.

Exclusion Criteria

History of allergy to bupivacaine

Foley catheterization

Pregnancy (which is a contraindication to elective ureteroscopy)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either 50 ml of 0.25% bupivacaine or a placebo of 50 ml of Normal Saline following ureteroscopy, laser lithotripsy, and ureteral stenting

Immediate post-operative period

1 visit (in-person)

Follow-up

Participants are monitored for post-operative pain and quality of life using a Visual Analog Scale and Ureteral Stent Symptom Questionnaire

5 days

Multiple assessments at 30 minutes, 60 minutes, 6 hours, 24 hours, and on post-operative day 5

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine

Trial Overview The study is testing the effectiveness of bupivacaine, a local anesthetic, in reducing pain after ureteroscopy compared to normal saline (a placebo). Patients will be randomly assigned to receive either bupivacaine or saline in their bladder post-surgery.

How Is the Trial Designed?

Group I: 50 ml of 0.25% bupivacaine Experimental Treatment 1 Intervention

Group II: placebo of 50 ml of Normal Saline Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

Bupivacaine hydrochloride (Marcaine) is highlighted for its increased duration of action compared to other local anesthetics, making it particularly useful in oral surgery.

It also has a favorable potency to toxicity ratio, suggesting that it provides effective pain relief with a lower risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review. Babst, CR., Gilling, BN.[2018]

In a study of 94 patients undergoing percutaneous nephrolithotomy, those treated with bupivacaine experienced significantly lower postoperative pain scores compared to those given a placebo, indicating its efficacy in pain management.

The mean pain score at 24 hours was 5.22 for the bupivacaine group versus 7.85 for the placebo group, demonstrating that bupivacaine infiltration is both effective and safe for managing pain after this surgical procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Pain Score of Bupivacaine versus Placebo in Patients Undergoing Percutaneous Nephrolithotomy. Khan, SA., Khalid, SE., Effendi, FN., et al.[2019]

Bupivacaine, used in various concentrations (0.25%, 0.5%, 0.75%) for different types of anesthesia, consistently provided complete sensory anesthesia for a wide range of surgical procedures, with onset times of 4 to 10 minutes and maximum effect in 15 to 35 minutes.

While there were 15 reported systemic toxic reactions, none led to lasting harm, indicating that Bupivacaine can be used safely in clinical settings, although careful monitoring is necessary, especially with higher doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review of 11,080 cases. Moore, DC., Bridenbaugh, LD., Thompson, GE., et al.[2019]

Infusing bupivacaine through the nephrostomy tract after tubeless percutaneous nephrolithotomy (PCNL) significantly reduces the need for narcotics, with patients requiring much less pethidine compared to the control group (20.5 mg vs 3.97 mg).

Patients receiving bupivacaine reported lower pain levels after 18 and 24 hours post-surgery and had a longer time before needing additional pain relief (11.35 hours vs 6.44 hours), indicating effective pain management with this method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent perirenal instillation of bupivacaine after tubeless percutaneous nephrolithotomy under spinal anesthesia: a double-blind, placebo-controlled clinical trial. Sharifi, SH., Soltani, MH., Rezaeetalab, GH., et al.[2018]

Bupivacaine with a vasoconstrictor has a shorter onset time for local anesthesia compared to bupivacaine without a vasoconstrictor, but the duration of anesthesia is longer without the vasoconstrictor.

Using bupivacaine without a vasoconstrictor resulted in lower postoperative pain levels and better blood circulation, which is beneficial for the osseointegration of dental implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. Duka, M., Lazić, Z., Stamatović, N., et al.[2019]

Bupivacaine (Marcaine) is effective for epidural analgesia in obstetrics, providing excellent sensory block with minimal impact on motor function and few side effects for both mothers and newborns.

When used at concentrations below 0.5%, and with careful dosing during labor, the risk of side effects and toxicity is low, and significant effects on newborns are rare due to the drug's high protein binding limiting its transfer across the placenta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6927176/

Influence of anesthesia methods on surgical outcomes and ... Results. Stone-free rate was higher in the GA (92.3%, 36 of 39) than the SA (71.0%, 22 of 31) (P = 0.019) group. Pain score was higher in the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03043027

Efficacy of Liposomal Bupivacaine for Pain Control After ... The following data will also be recorded and serve as the secondary outcomes: Patient's pain rating at 6, 12, and 48 hours in all arms; Patient's pain rating ...

3. ijlbpr.com ijlbpr.com/uploadfiles/165vol14issue7pp970-974.20250723054549.pdf

A Comparative Study of Spinal Anaesthesia with 0.5% ... Stone-free rates (91.7% vs 93.3%) and patient/surgeon satisfaction scores were comparable between groups. Conclusion: 0.75% ropivacaine provides ...

4. europeanreview.org europeanreview.org/wp/wp-content/uploads/4951-4959.pdf

The efficacy of bupivacaine infiltration along nephrostomy ... The secondary outcomes were the time for first opioid demands, the num- ber of opioid demands, and the total opioid con- sumption over the 48 h postoperatively.

5. auajournals.org auajournals.org/doi/pdf/10.1016/j.juro.2007.05.025

Subcutaneous Bupivacaine Infiltration and Postoperative ... Purpose: Recent studies have shown a significant decrease in patient reported pain scores when the nephrostomy tube size.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30369379/

Postoperative Pain Score of Bupivacaine versus Placebo ... Bupivacaine infiltration into the nephrostomy tract is a highly effective and safe in postoperative pain management for patients undergoing standard PCNL.

7. impactfactor.org impactfactor.org/PDF/IJCPR/16/IJCPR,Vol16,Issue10,Article55.pdf

Clinical Outcomes of Spinal Anesthesia with 0.5 ... - Impactfactor The present study was undertaken to compare the efficacy and safety of spinal anesthesia using intrathecal isobaric ropivacaine 0.75% and hyperbaric bupivacaine ...