ESP Block for Pain After Kidney Stone Surgery

Overseen By Aimee Pehrson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Tennessee Medical Center

Must not be taking: Opioids, Recreational drugs

Disqualifiers: Pregnancy, Local infection, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 day

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a special type of pain relief, the erector spinae (ESP) block, after kidney stone surgery. Researchers aim to determine if it reduces morphine use and pain compared to a simple saline injection. Participants will receive either the ESP block with ropivacaine (a numbing medicine) and dexamethasone (an anti-inflammatory) or just a saline injection. This study may suit adults scheduled for non-emergency kidney stone surgery who do not regularly use opioids. As an unphased trial, it offers participants the chance to contribute to innovative pain management research.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have been using opioids for more than 90 days in the past year, you cannot participate.

What prior data suggests that the erector spinae block is safe for reducing pain after kidney stone surgery?

Research has shown that the erector spinae plane (ESP) block is generally safe for managing pain after kidney stone surgery. Studies have found that patients receiving an ESP block experience good pain relief with few side effects. In one study with 68 patients, the ESP block was well-tolerated.

The anesthetic used in the block, ropivacaine, is safe when used properly. Dexamethasone, a steroid added to reduce swelling, is also commonly used and has a good safety record. Reports suggest that these treatments together effectively manage pain without major side effects.

While the ESP block works well, its pain-relieving effects are usually short-term. Overall, the treatment is considered safe, and side effects are rare. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ESP Block with ropivacaine and dexamethasone for post-kidney stone surgery pain because it offers a targeted approach to pain management. Unlike opioids, which are commonly used and can lead to significant side effects and dependency, this method involves a local anesthetic technique that directly numbs the nerves near the spine, providing pain relief right where it's needed. Additionally, combining ropivacaine with dexamethasone may enhance and prolong the pain relief effect without the systemic impact of traditional pain medications. This innovative approach aims to reduce reliance on opioids, offering a potentially safer and more effective pain management solution.

What evidence suggests that the ESP block is effective for reducing pain after kidney stone surgery?

In this trial, participants in the ESP Group will receive an erector spinae plane (ESP) block with ropivacaine and dexamethasone. Research shows this method can effectively reduce pain and lessen the need for painkillers after kidney stone surgery. One study found that patients who received an ESP block used fewer opioids and experienced less pain post-surgery. Another study confirmed that this block provides significant pain relief soon after surgery. Additionally, the ESP block has demonstrated long-lasting pain control after these procedures. These findings suggest that the ESP block might help manage pain and reduce opioid use in patients recovering from kidney stone surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

Jason Buehler, MD

Principal Investigator

University of Tennessee Medical Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who are having non-emergency kidney stone surgery (percutaneous nephrolithotomy) during weekdays. They must be able to understand and explain the consent process, and women of childbearing age need a negative pregnancy test.

Inclusion Criteria

Ability to understand and teach back consent for the procedure

Willingness to sign consent for procedure

I can have children and will provide a negative pregnancy test.

Exclusion Criteria

Opioid use >90 days in the year leading up to surgery

Pregnancy or breastfeeding

I do not have any health conditions that would make the trial unsafe for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo percutaneous nephrolithotomy and receive either an ESP block or a control block

1 day

1 visit (in-person)

Immediate Post-operative Monitoring

Participants are monitored for opioid consumption and pain levels using VAS scores in the first 24 hours post-surgery

24 hours

Follow-up

Participants are monitored for recovery quality and opioid use at 24 hours, 48 hours, 7 days, and 30 days post-surgery

30 days

4 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone
• Erector Spinae Plane Block
• Ropivacaine 0.5% Injectable Solution

Trial Overview The study tests if an ESP block with Ropivacaine and Dexamethasone reduces painkiller needs after kidney stone surgery compared to a saline solution control. It also looks at its effect on reported pain levels post-surgery.

How Is the Trial Designed?

Group I: ESP Group Active Control 3 Interventions

One 30mL syringe containing 30mL of 0.5% ropivacaine and 4 mg of dexamethosone-

Group II: Sham Group Placebo Group 1 Intervention

One 30mL syringe containing 30mL of preservative free normal saline

Who Is Running the Clinical Trial?

University of Tennessee Medical Center

Lead Sponsor

Trials

7

Recruited

450+

Published Research Related to This Trial

Adding 20 mg of nalbuphine to ropivacaine in an erector spinae plane block significantly prolongs the time to first opioid demand after percutaneous nephrolithotomy, with a median time of 8.70 hours compared to 2.90 hours for ropivacaine alone.

The combination of nalbuphine and ropivacaine also reduces postoperative morphine consumption, indicating enhanced analgesic efficacy without compromising safety, as VAS pain scores remained comparable across all groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic Efficacy of Nalbuphine as an Adjuvant to Ropivacaine in Erector Spinae Plane Block for Percutaneous Nephrolithotomy: A Randomized, Double-Blinded, Clinical Trial. Sun, M., Wu, Z., Wang, R., et al.[2023]

The erector spinae plane block (ESPB) significantly reduced the need for opioids post-surgery, with lower total morphine consumption in the first 48 hours compared to intravenous patient-controlled analgesia (PCA).

Patients receiving ESPB experienced longer time to first analgesic request and lower pain scores at rest and during movement, indicating more effective pain management after open nephrectomy for renal malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound Guided Continuous Erector Spinae Plane Block versus Patient Controlled Analgesia in Open Nephrectomy for Renal Malignancies: A Randomized Controlled Study. Abdelgalil, AS., Ahmed, AM., Gamal, RM., et al.[2022]

In a study of 60 patients undergoing percutaneous nephrolithotomy, the erector spinae plane block (ESPB) significantly reduced postoperative pain levels compared to the control group, as measured by the visual analog scale (VAS) at multiple time points (0, 6, and 24 hours).

Patients receiving the ESPB also experienced better respiratory outcomes, with a lower incidence of agitation and improved peak expiratory flow rates (PEFR) compared to those who only received intravenous analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should the Erector Spinae Plane Block Be Applied in the Pain Management of Percutaneous Nephrolithotomy? Unal, S., Baskan, S., Guven Aytac, B., et al.[2022]

In a clinical trial involving nephrectomy patients, those who received an erector spinae plane (ESP) block reported significantly lower pain scores in the first 24 hours post-surgery compared to those who did not receive the block.

The ESP block group also used fewer opioids and had better recovery quality, indicating that this technique may enhance postoperative pain management and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of ultrasound-guided erector spinae plane block on post-surgical pain in patients undergoing nephrectomy: a single-center, randomized, double-blind, controlled trial. Şahin, A., Baran, O.[2022]

In a study of 40 patients with renal colic, the erector spinae plane (ESP) block provided significantly better pain relief compared to intravenous NSAIDs, as indicated by lower visual analogue scale (VAS) scores at multiple time points after the procedure.

Patients receiving the ESP block also required no opioids for pain management, while those in the NSAID group had a higher opioid consumption, highlighting the ESP block as a safer and more effective alternative for acute renal colic pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erector spinae plane block vs non-steroidal anti-inflammatory drugs for severe renal colic pain: A pilot clinical feasibility study. Aydin, ME., Tekin, E., Ahiskalioglu, EO., et al.[2021]

In a case series of 10 patients undergoing bilateral erector spinae plane (ESP) block for lumbar spine surgery, lidocaine showed a rapid absorption with peak concentrations (Cmax) ranging from 1.2 to 3.8 mg/L, which remained below toxicity limits.

The pharmacokinetics of lidocaine after ESP block indicated high bioavailability (average AUC0-3 of 76%) and a slightly prolonged elimination half-life in older patients, suggesting that age may influence drug metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of lidocaine after bilateral ESP block. De Cassai, A., Bonanno, C., Padrini, R., et al.[2021]

The Erector Spinae Plane (ESP) block provided significantly longer pain relief after percutaneous nephrolithotomy (PCNL) compared to conventional peritubular local anesthetic infiltration, with patients in the ESP group waiting an average of 16.21 hours for their first rescue analgesic compared to 6.93 hours in the peritubular group.

Patients receiving the ESP block reported lower pain scores and required fewer rescue analgesics in the first 24 hours post-surgery, indicating that the ESP block is a highly effective and safe method for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy of erector spinae plane block and peritubal infiltration of levobupivacaine for postoperative analgesia following percutaneous nephrolithotomy. Lomate, P., Jadhav, VR., Yadav, A.[2022]

In a study involving 36 patients (18 receiving Erector spinae plane blocks and 18 receiving Pectointercostal fascial plane blocks), the maximum plasma concentrations of bupivacaine were found to be significantly lower than toxic levels, indicating a safe profile for these anesthetic techniques.

The timing for peak plasma concentrations (Tmax) of bupivacaine varied, with Erector spinae plane blocks reaching their peak at around 30 minutes, while Pectointercostal fascial plane blocks peaked later at about 180 minutes, suggesting different pharmacokinetic profiles for these two methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peak plasma concentration of total and free bupivacaine after erector spinae plane and pectointercostal fascial plane blocks. Maximos, S., Vaillancourt-Jean, É., Mouksassi, S., et al.[2022]

In a study of 80 patients undergoing lumbar spinal surgery, a two-level erector spinae plane (ESP) block was found to provide better sensory coverage of the surgical incision compared to a one-level block, with 100% coverage in the two-level group versus 85% in the one-level group.

Despite the two-level block taking longer to perform, it did not lead to increased complications or higher postoperative pain scores, indicating it is a safe and effective method for enhancing analgesia in spinal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the feasibility and validity of a one-level and a two-level erector spinae plane block combined with general anesthesia for patients undergoing lumbar surgery. Zheng, S., Zhou, Y., Zhang, W., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10339747/

The Efficacy of Erector Spinae Plane Block for Patients ... Our results showed that erector spinae plane block (ESPB) reduces intraoperative and postoperative opioid consumption and postoperative pain ...

2. mdpi.com mdpi.com/1660-4601/18/7/3625

Erector Spinae Plane Block for Perioperative Analgesia ... Erector spinae plane block is an effective pain treatment after percutaneous nephrolithotomy but only for a very short postoperative period.

3. journals.lww.com journals.lww.com/joacp/fulltext/2021/10000/comparison_of_the_efficacy_of_erector_spinae_plane.15.aspx

Comparison of the efficacy of erector spinae plane block... ESP block is a very effective and safe technique to provide prolonged duration of postoperative analgesia following PCNL. Peritubal local anesthetic ...

4. jag.journalagent.com jag.journalagent.com/z4/download_fulltext.asp?pdir=agri&plng=tur&un=AGRI-24650

Evaluation of erector spinae plane block in patients ... This study aimed to investigate the efficacy of the erector spinae plane block (ESPB) in reducing both intraoperative opioid consumption and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06131151

Comparison Between External Oblique Intercostal Block ... The aim of this study is to compare the post-operative analgesic effect of USG unilateral External oblique intercostal (EOI) block with Erector spinae plane ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8036507/

Erector Spinae Plane Block for Perioperative Analgesia ... Erector spinae plane block is an effective pain treatment after percutaneous nephrolithotomy but only for a very short postoperative period.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11867357/

Efficacy of erector spinae plane block for postoperative ... We performed a systematic review and meta-analysis on the use of ESPB for perioperative analgesia in PCNL for renal stone disease. A systematic literature ...

8. researchgate.net researchgate.net/publication/350540280_Erector_Spinae_Plane_Block_for_Perioperative_Analgesia_after_Percutaneous_Nephrolithotomy

Erector Spinae Plane Block for Perioperative Analgesia ... The aim of our study was to test the efficacy and safety of erector spinae plane block after percutaneous nephrolithotomy. We analyzed 68 patients, 34 of whom ...

9. pdfs.semanticscholar.org pdfs.semanticscholar.org/eea2/433d5f8a7aed806eb7cc4200f8f9a66b566f.pdf

Erector Spinae Plane Block for Perioperative Analgesia ... The aim of our study was to test the efficacy and safety of erector spinae plane block after percutaneous nephrolithotomy. We analyzed 68 ...

10. journals.lww.com journals.lww.com/md-journal/fulltext/2020/10020/erector_spinae_plane_block_with_catheter_for.61.aspx

Erector spinae plane block with catheter for management of... Outcomes: No opioid or other pain medications, other than the local anesthetic solution given in the ESPCs, were used during the intra-operative ...