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

Trial Summary

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.

What data supports the effectiveness of the drug Bupivacaine for treating kidney stones?

Bupivacaine, also known as Marcaine, is a long-acting local anesthetic that has been shown to provide effective pain relief in various surgical procedures, including oral surgery and obstetrical analgesia, with minimal side effects. Its ability to produce complete sensory anesthesia and its favorable potency to toxicity ratio suggest it could be effective in managing pain associated with kidney stone procedures. ^{1 2 3 4 5}

Is Bupivacaine safe for use in humans?

Bupivacaine, also known as Marcaine, is generally considered safe when used as a local anesthetic in various medical procedures, with minimal side effects if dose recommendations are followed. In a review of 11,080 cases, only 15 systemic toxic reactions were reported, and no serious long-term effects were noted. ^{1 2 3 4 5}

How does the drug bupivacaine differ from other treatments for kidney stones?

Bupivacaine is unique for kidney stone treatment because it is a long-acting local anesthetic that can be used to manage pain after procedures like percutaneous nephrolithotomy (a type of kidney stone removal surgery). Unlike other pain management options, bupivacaine provides targeted pain relief at the surgery site, potentially reducing the need for narcotics. ^{1 2 4 5 6}

What is the purpose of this trial?

Post-operative pain and lower urinary tract symptoms are common following ureteroscopy in the treatment of stone disease. The use of bupivacaine as a topical pain medication is used routinely for other urologic procedures, however, to date there are no studies that have rigorously investigated the effect of instilling bupivacaine in the bladder following ureteroscopy. This is a randomized study that will investigate the effect of instilling bupivacaine in the bladder following routine ureteroscopy, laser lithotripsy and ureteral stenting in the treatment of stone disease. Compared to a placebo of Normal Saline, our study hypothesizes that administration of topical bupivacaine in the bladder will decrease post-operative pain and lower urinary tract symptoms while improving quality of life in the early post-operative period.

Research Team

Luke Reynolds, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. [2013]

2. Pakistan pubmed.ncbi.nlm.nih.gov

Postoperative Pain Score of Bupivacaine versus Placebo in Patients Undergoing Percutaneous Nephrolithotomy. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Bupivacaine: a review of 11,080 cases. [2019]

5. Serbia pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Intermittent perirenal instillation of bupivacaine after tubeless percutaneous nephrolithotomy under spinal anesthesia: a double-blind, placebo-controlled clinical trial. [2018]