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: Unknown

90 Participants Needed

Trial Summary

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.

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 data supports the idea that Pain Management for Kidney Stone Surgery is an effective treatment?

The available research shows that Pain Management for Kidney Stone Surgery, specifically through percutaneous nephrolithotomy (PCNL), is effective in reducing pain and the need for narcotics. One study found that patients who underwent PCNL required significantly fewer doses of narcotics compared to those who had open surgery, with PCNL patients needing only 6.5 doses compared to 21 doses for open surgery patients. Another study demonstrated that using a non-opioid pain regimen after PCNL was feasible, suggesting that effective pain control can be achieved without relying on opioids. These findings indicate that PCNL is a less painful option and can help reduce narcotic use, making it an effective treatment for managing pain after kidney stone surgery. ^{1 2 3 4 5}

What safety data exists for pain management in kidney stone surgery?

The safety data for pain management in kidney stone surgery, specifically percutaneous nephrolithotomy (PCNL), includes studies on various pain management strategies. These studies explore the use of non-narcotic pain regimens, such as local anesthetics like bupivacaine and ropivacaine, to reduce narcotic use and improve postoperative outcomes. Research also evaluates the feasibility of opioid-free PCNL, highlighting the potential for non-opioid pain management to address the opioid crisis. Additionally, the use of paravertebral blocks with bupivacaine and clonidine has been studied to minimize the need for systemic analgesics. Overall, these studies suggest that alternative pain management strategies can be effective and may improve safety by reducing reliance on narcotics. ^{1 2 3 4 6}

Is Narcotic-Free Percutaneous Nephrolithotomy a promising treatment for pain management after kidney stone surgery?

Yes, Narcotic-Free Percutaneous Nephrolithotomy (PCNL) is a promising treatment. It aims to manage pain without using narcotics, which is important given the opioid crisis. Studies show that PCNL can effectively reduce pain and the need for narcotics compared to traditional methods. This approach can help patients recover with less reliance on painkillers. ^{1 2 3 4 5}

Research Team

Mantu Gupta, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Predictors of narcotic use after percutaneous nephrolithotomy. [2017]

2. 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]

3. United States 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. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Opioid-free percutaneous nephrolithotomy: an initial experience. [2023]

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

Pain control: comparison of percutaneous and operative nephrolithotomy. [2020]

6. India 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. [2020]