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Kidney StonePhase 4NCT04663269

Regional Erector Spinae Analgesic Block vs Standard of Care Undergoing Percutaneous Nephrolithotomy

A Phase 4 study testing 4mg PF Dexamethasone in people with Kidney Stone and Surgery, run by Indiana University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine if adding a spinal block (medicine that will numb parts of the body to block pain) along with standard pain control at the incision site will decrease the need for narcotics for pain management and decrease the percentage of patients requiring hospital admission for pain… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Stone, Surgery
What is being tested?
4mg PF Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
24 Feb 2020to 24 Sep 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years Undergoing unilateral or bilateral PCNL for treatment of kidney stones Estimated glomerular filtration rate > 30 mL/min. PCNL is planned as an outpatient procedure with no overnight hospital stay

Who cannot join

  • Inability to provide informed consent Pregnancy Patients having any additional simultaneous procedures other than a contralateral PCNL,(including contralateral treatment of kidney stones with a non-PCNL operation such as ureteroscopy) Patients with a documented neurologic injury that reduces pain sensation to the back Patients with an existing pain disorder Patients with an existing narcotics agreement due to current or prior narcotic abuse Patients with a documented allergy to a narcotic or NSAID analgesic BMI > 35 Patients who require more than 1 site of percutaneous access into the kidney to adequately complete the PCNL (this is a judgment made preoperatively at the initial clinic patient encounter)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Methodist University

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: Randomized, Prospective Trial of Regional Erector Spinae Analgesic Block Versus Standard of Care in Patients Undergoing Percutaneous Nephrolithotomy

The purpose of this study is to determine if adding a spinal block (medicine that will numb parts of the body to block pain) along with standard pain control at the incision site will decrease the need for narcotics for pain management and decrease the percentage of patients requiring hospital admission for pain control during postoperative , in-hospital, care after a percutaneous nephrolithotomy (PCNL) (surgery to remove kidney stones), commonly called PERC.

Being tested
4mg PF Dexamethasone, Control Test
Medical subject headings
Kidney Calculi

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 4mg PF DexamethasoneDrug

    analgesic provided in the erector spinae block is 20mL of 0.5% Bupivicaine with 4mg of PF Dexamethasone

  • Control TestDrug

    Also called Standard of Care

    Peritubal block - standard local analgesic administration

Study groups in NCT04663269
Study groupRoleWhat they receive
ControlOtherStandard Care Protocol - peritubal block standard local analgesic administration in the form of a peritubal block
Receives: Drug: Control Test
ANES BlockExperimentalPatients randomized to the erector spinae block (Group 2) will have the block placed in the preoperative area by the anesthesia team. 0-4 mg midazolam and/or 0-100 mcg of fentanyl may be provided prior to and in order to place the block itself. The local anesthetic will diffuse to involve the dorsal and ventral rami of the spinal nerves, achieving a sensory block of the affected area. The erector spinae block analgesic will be administered by the anesthesia team. The analgesic provided in the erector spinae block is 20mL of 0.5% Bupivicaine with 4mg of PF Dexamethasone.
Receives: Drug: 4mg PF Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overnight Admission Rate

    Percentage of patients in Groups 1 and 2 who require overnight admission to the hospital for pain control postoperatively (i.e. patients unable to be discharged to home from the postoperative anesthesia care unit PACU).

    Measured: 24 hours

Secondary outcomes (7)

  1. Narcotic for Analgesia post-operatively

    Comparison of the percentage of patients in Groups 1 and 2 who require any narcotic for analgesia during the postoperative course following PCNL.

    Measured: 14 days post-op

  2. Proportion of patients with Emergency Department return or re-admission

    Proportion of patient successfully discharged from PACU without return to Emergency Department or requiring re-admission within 14 days post discharge.

    Measured: 14 days

  3. Number of Narcotic administrations post-operatively

    Of patients requiring narcotics during the hospitalization, how many administrations of narcotics did these patients receive

    Measured: 14 days

  4. Number of Morphine Equivalents post-operatively

    Of patients requiring narcotics during the hospitalization, how many administrations of narcotics did these patients receive in daily morphine equivalents

    Measured: 14 days

  5. Number of complications peri and post-operatively

    Any complications (according to Clavien-Dindo classification11) during the surgery and postoperative hospital stay

    Measured: 24 hours

  6. Pain Score

    Maximum patient reported pain score within the first 24 hours post operatively using 0-10 numeric pain intensity scale (NPIS) where 0 is no pain, 5 is moderate pain and 10 is the worst possible pain.

    Measured: 24 hours

  7. Rate of Adjunct Analgesics Post-operatively

    Nonsteroidal Anti-inflammatories

    • Y/N
    • If Yes, name \& dose
    • If Yes, total # of times administered
    • If Yes total # of times administered/(LOS in hours/24)

    Gabbapentinoids

    • Y/N
    • If Yes, name \& dose
    • If Yes, total # of times administered
    • If Yes total # of times administered/(LOS in hours/24)

    Acetaminophen

    • Y/N
    • If Yes, name \& dose
    • If Yes, total # of times administered
    • If Yes total # of times administered/(LOS in hours/24)

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2020
  2. Study start24 Feb 2020
  3. Primary completion11 Sep 2020
  4. Study completion24 Sep 2020

Why it stopped: Drop out from surgeons from 3 to 1. It will take too long to feasibly accrue with only one provider.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04663269
Sponsor's protocol ID
87943342
Status last verified
Apr 2021
First submitted
20 Nov 2020
Last updated
23 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jonnavithula N, Pisapati MV, Durga P, Krishnamurthy V, Chilumu R, Reddy B. Efficacy of peritubal local anesthetic infiltration in alleviating postoperative pain in percutaneous nephrolithotomy. J Endourol. 2009 May;23(5):857-60. doi: 10.1089/end.2008.0634.

    PubMed 19397429

  • Parikh GP, Shah VR, Modi MP, Chauhan NC. The analgesic efficacy of peritubal infiltration of 0.25% bupivacaine in percutaneous nephrolithotomy - A prospective randomized study. J Anaesthesiol Clin Pharmacol. 2011 Oct;27(4):481-4. doi: 10.4103/0970-9185.86591.

    PubMed 22096280

  • Ozkan D, Akkaya T, Karakoyunlu N, Arik E, Ergil J, Koc Z, Gumus H, Ersoy H. Effect of ultrasound-guided intercostal nerve block on postoperative pain after percutaneous nephrolithotomy : prospective randomized controlled study. Anaesthesist. 2013 Dec;62(12):988-94. doi: 10.1007/s00101-013-2253-z. Epub 2013 Nov 1.

    PubMed 24173546

  • Honey RJ, Ghiculete D, Ray AA, Pace KT. A randomized, double-blinded, placebo-controlled trial of intercostal nerve block after percutaneous nephrolithotomy. J Endourol. 2013 Apr;27(4):415-9. doi: 10.1089/end.2012.0418.

    PubMed 23445266

  • Yang H, Yu X, Hu J, Peng E, Li C, Cui L, Zhao C, Wang S, Wei C, Mei W, Wang S, Ye Z. Usage of Multilevel Paravertebral Block as the Main Anesthesia for Mini-Invasive PCNL: Retrospective Review of 45 Cases with Large Stones. Urol Int. 2017;99(3):326-330. doi: 10.1159/000480094. Epub 2017 Aug 30.

    PubMed 28850954

  • Jonnavithula N, Chirra RR, Pasupuleti SL, Devraj R, Sriramoju V, Pisapati MV. A comparison of the efficacy of intercostal nerve block and peritubal infiltration of ropivacaine for post-operative analgesia following percutaneous nephrolithotomy: A prospective randomised double-blind study. Indian J Anaesth. 2017 Aug;61(8):655-660. doi: 10.4103/ija.IJA_88_17.

    PubMed 28890561

  • Hatipoglu Z, Gulec E, Turktan M, Izol V, Aridogan A, Gunes Y, Ozcengiz D. Comparative study of ultrasound-guided paravertebral block versus intravenous tramadol for postoperative pain control in percutaneous nephrolithotomy. BMC Anesthesiol. 2018 Feb 17;18(1):24. doi: 10.1186/s12871-018-0479-7.

    PubMed 29454333

  • Malekpour M, Hashmi A, Dove J, Torres D, Wild J. Analgesic Choice in Management of Rib Fractures: Paravertebral Block or Epidural Analgesia? Anesth Analg. 2017 Jun;124(6):1906-1911. doi: 10.1213/ANE.0000000000002113.

    PubMed 28525509

  • Yeying G, Liyong Y, Yuebo C, Yu Z, Guangao Y, Weihu M, Liujun Z. Thoracic paravertebral block versus intravenous patient-controlled analgesia for pain treatment in patients with multiple rib fractures. J Int Med Res. 2017 Dec;45(6):2085-2091. doi: 10.1177/0300060517710068. Epub 2017 Jun 21.

    PubMed 28635359

  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

    PubMed 15273542

  • Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

    PubMed 18929686

  • Miller NL, Matlaga BR, Lingeman JE. Techniques for fluoroscopic percutaneous renal access. J Urol. 2007 Jul;178(1):15-23. doi: 10.1016/j.juro.2007.03.014. Epub 2007 May 11.

    PubMed 17574053

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 4mg PF Dexamethasone in people with Kidney Stone and Surgery, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Drop out from surgeons from 3 to 1. It will take too long to feasibly accrue with only one provider.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overnight Admission Rate (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04663269, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.

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