Pain Management for Kidney Stone Surgery

Overseen By Blair Gallante

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Antiplatelets, Anticoagulants, NSAIDs, MAOIs

Disqualifiers: Pregnancy, Chronic opioid abuse, Pulmonary disease, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which pain relief works better after kidney stone surgery: oral ketorolac (a non-opioid painkiller) or standard opioid medication. Researchers divide participants into two groups, with one group receiving ketorolac and the other receiving oxycodone. The trial targets individuals scheduled for a specific type of kidney stone surgery, Narcotic-Free Percutaneous Nephrolithotomy (PCNL), with a stone burden of at least 2 cm. As a Phase 4 trial, this research helps to understand how these FDA-approved treatments can benefit more patients.

Do I need to stop my current medications to join the trial?

Yes, you may need to stop certain medications. The trial excludes participants taking NSAIDs, antiplatelet or anticoagulation medications, probenecid, pentoxifylline, MAOIs, mixed agonist/antagonist and partial agonist opioid analgesics, nephrotoxic medications, and those that increase sedation risk like benzodiazepines.

What is the safety track record for these treatments?

Research shows that ketorolac, a non-steroidal anti-inflammatory drug (NSAID), is generally safe and well-tolerated after kidney stone surgeries. Studies have found that ketorolac provides pain relief similar to opioids but with a lower risk of addiction. One study demonstrated that patients who avoided opioids after kidney stone removal surgery experienced safe outcomes.

Research also supports managing this surgery without narcotics. Data suggest that using ketorolac instead of opioids effectively manages pain without major side effects. The evidence indicates that this approach can be a safe and reliable way to manage pain after surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the narcotic-free approach to pain management for kidney stone surgery because it offers a potential alternative to opioids, which are the current standard of care. Unlike traditional treatments that rely on drugs like Oxycodone, this approach focuses on using NSAIDs such as Ketorolac. This is significant because it could reduce the risk of opioid dependence and related side effects. Additionally, Ketorolac provides effective pain relief without the sedation and addiction concerns associated with narcotics, making it a safer option for patients post-surgery.

What evidence suggests that this trial's treatments could be effective for pain management after kidney stone surgery?

Research has shown that ketorolac, which participants in this trial may receive, works as well as opioids for pain relief after kidney stone surgery. One study found that ketorolac and oxycodone-acetaminophen provided similar pain relief, while another confirmed ketorolac's effectiveness compared to opioids. This trial will compare ketorolac, used in the NSAID arm, with oxycodone, used in the opioid group, to evaluate their effectiveness in managing post-surgery pain. Thus, ketorolac can serve as a strong alternative to opioids for managing pain after surgery, without the risk of addiction. ^{1 6 7 8 9}

Who Is on the Research Team?

Mantu Gupta, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults with large kidney stones (at least 2cm) who are scheduled for a specific minimally invasive surgery (PCNL). It's not for pregnant women, those with chronic opioid abuse, NSAID allergies or severe kidney issues, bleeding risks, or on certain medications like blood thinners and MAOIs.

Inclusion Criteria

I am scheduled for a specific kidney stone removal surgery with a large stone.

Exclusion Criteria

I am not on MAOIs, opioids, have no chronic pain, abnormal sensations, or urinary tract issues, and do not have pulmonary, liver diseases, seizure disorders, nor take nephrotoxic or sedative medications.

I cannot take NSAIDs due to allergies, kidney issues, stomach ulcers, bleeding risks, or because I'm on blood thinners.

I am not taking NSAIDs, blood thinners, probenecid, or pentoxifylline.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo percutaneous nephrolithotomy (PCNL) and receive either oral ketorolac or oxycodone for post-operative analgesia

10 days

Post-operative monitoring on days 1-5 and day 10

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores, pill counts, and patient-related outcome surveys

10 days

Follow-up assessments on day 10

What Are the Treatments Tested in This Trial?

Interventions

• Ketorolac
• Narcotic-Free Percutaneous Nephrolithotomy

Trial Overview The study compares two pain relief options after kidney stone surgery: oral ketorolac (a non-opioid painkiller) and oxycodone (an opioid), given as needed every six hours. Patients will be randomly assigned to one of the two drugs to assess effectiveness and safety.

How Is the Trial Designed?

Group I: Opioid group Active Control 1 Intervention

Patients will be prescribed 5mg Oxycodone, Q6 PRN postoperatively.

Group II: NSAID Active Control 1 Intervention

Patients will be prescribed 10mg Ketorolac, Q6 PRN postoperatively.

Narcotic-Free Percutaneous Nephrolithotomy is already approved in United States, European Union for the following indications:

Approved in United States as Percutaneous Nephrolithotomy for:

• Kidney stones larger than 2 cm
• Multiple large kidney stones
• Stones resistant to ESWL or ureteroscopy

Approved in European Union as Percutaneous Nephrolithotomy for:

• Renal stones greater than 20 mm
• Staghorn and partial staghorn calculi
• Calyceal diverticular stones

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

Percutaneous nephrolithotomy, a minimally invasive procedure for removing kidney stones, resulted in significantly lower narcotic use (6.5 doses) compared to open nephrolithotomy (21 doses) among 21 patients, indicating less pain associated with the former.

Patients undergoing percutaneous nephrolithotomy had shorter hospital stays (8.9 days) compared to those who had open nephrolithotomy (11.0 days), highlighting the procedure's effectiveness and reduced morbidity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain control: comparison of percutaneous and operative nephrolithotomy. Rittenberg, MH., Koolpe, H., Keeler, L., et al.[2020]

In a study of 34 patients undergoing percutaneous nephrolithotomy (PCNL), the combination of local anesthetic ropivacaine and parenteral metamizol significantly reduced pain levels and the need for additional analgesics compared to metamizol alone.

Patients receiving ropivacaine also showed improved peak expiratory flow rates (PEF), indicating better ventilation post-surgery, suggesting that effective pain management can enhance respiratory function after PCNL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Instillation of skin, nephrostomy tract, and renal puncture site with ropivacaine decreases pain and improves ventilatory function after percutaneous nephrolithotomy. Ugras, MY., Toprak, HI., Gunen, H., et al.[2022]

In a study of 243 patients undergoing percutaneous nephrolithotomy (PCNL), those aged 20-39, males, and individuals with prior narcotic use were found to require significantly higher doses of narcotics post-surgery, indicating specific patient characteristics that influence pain management needs.

Understanding these factors can help healthcare providers better manage patient expectations and improve postoperative care, potentially reducing the risks associated with high narcotic usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of narcotic use after percutaneous nephrolithotomy. Khater, N., Keheila, M., Lightfoot, M., et al.[2017]

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]

A study comparing post-operative pain management in 140 patients undergoing percutaneous nephrolithotomy (PCNL) found that using ketorolac (a non-opioid) instead of oxycodone-acetaminophen did not lead to more pain-related healthcare encounters, suggesting that a non-opioid regimen can be effective.

Patients prescribed oxycodone-acetaminophen had significantly more unplanned phone calls for pain management, indicating that a non-opioid approach may reduce the need for additional pain-related communication without compromising pain control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid-free percutaneous nephrolithotomy: an initial experience. Khargi, R., Yaghoubian, AJ., Blake, RM., et al.[2023]

Paravertebral block using 0.5% Bupivacaine, with or without Clonidine, effectively provides intraoperative and postoperative analgesia for patients undergoing Percutaneous Nephrolithotomy (PCNL), reducing the need for additional anesthetics and maintaining stable hemodynamics.

The addition of Clonidine to Bupivacaine significantly enhances analgesic quality, leading to longer-lasting pain relief and greater reduction in intraoperative propofol requirements, all without causing adverse effects like bradycardia or respiratory compromise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Efficacy of Bupivacaine (0.5%) alone or with Clonidine (1μg/kg) Versus Control in a Single Level Paravertebral Blockin Patients Undergoing PCNL Procedure. Kamble, TS., Deshpande, CM.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03584373?tab=results

Pain Outcomes of Non-opioid vs. Opioid Analgesia for ... Ketorolac and Acetaminophen administered post surgery to compare pain outcomes to that of Percocet. Ketorolac Oral Tablet [Toradol]: Ketorolac is a prescribed ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36371742/

Optimizing pain management following kidney stone surgery Results: Analyses were based on 90 patients with postoperative pain data: 44 in the ketorolac group and 46 in the oxycodone-acetaminophen group.

3. auajournals.org auajournals.org/doi/10.1097/JU.0000000000002580.01

MP31-01 MINIMIZING NARCOTICS: A RANDOMIZED- ... Pain outcomes with non-opioid analgesia (Ketorolac) are non-inferior to opioid analgesia (acetaminophen/oxycodone) after kidney stone surgery.

4. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/10.1002/bco2.70038

Questionable role of opioids for analgesia in renal colic and its ... We review the updated literature about pain management of renal colic, a prevalent and painful urologic condition. Prescribers must know the ...

5. link.springer.com link.springer.com/article/10.1007/s00345-022-04249-z

Optimizing pain management following kidney stone surgery The authors conducted an open-label randomized non-inferiority clinical trial (RCT) to compare ketorolac to oxycodone-acetaminophen therapy for pain management ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/65/NCT05924165/Prot_SAP_001.pdf

Narcotic-Free Percutaneous Nephrolithotomy There is data that indicates the non-inferiority and safety of NSAIDs (mostly Ketorolac) compared to opioids in kidney stone (ureteroscopy.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12152362/

Questionable role of opioids for analgesia in renal colic ... The number of stones passed also correlated with increased opioid prevalence, with 0, 1, ≥ 2 prior stones resulting in 6%, 9% and 14% rates of ...

8. tau.amegroups.org tau.amegroups.org/article/view/138606/html

A prospective study to determine the safety and feasibility of ... We found that opioid-free discharge after percutaneous nephrolithotomy (PCNL) is safe and feasible in a limited prospective study utilizing a nonopioid ...

9. withpower.com withpower.com/trial/phase-4-nephrolithiasis-4-2023-2ffc5

Pain Management for Kidney Stone Surgery What is the purpose of this trial? This is a randomized control trial comparing oral ketorolac and opioid medication for the use of post-operative analgesia.