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

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ClinicalTrials.gov Identifier: NCT04663269
Recruitment Status : Terminated (Drop out from surgeons from 3 to 1. It will take too long to feasibly accrue with only one provider.)
First Posted : December 10, 2020
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Tim Large, Indiana University

Brief 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 control during postoperative , in-hospital, care after a percutaneous nephrolithotomy (PCNL) (surgery to remove kidney stones), commonly called PERC.

Condition or disease Intervention/treatment Phase
Kidney Stone Surgery Drug: 4mg PF Dexamethasone Drug: Control Test Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Anesthesia will know the randomization assignment. The surgeon and the patient will be blinded to randomization.
Primary Purpose: Other
Official Title: Randomized, Prospective Trial of Regional Erector Spinae Analgesic Block Versus Standard of Care in Patients Undergoing Percutaneous Nephrolithotomy
Actual Study Start Date : February 24, 2020
Actual Primary Completion Date : September 11, 2020
Actual Study Completion Date : September 24, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control
Standard Care Protocol - peritubal block standard local analgesic administration in the form of a peritubal block
Drug: Control Test
Peritubal block - standard local analgesic administration
Other Name: Standard of Care

Experimental: ANES Block
Patients 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.
Drug: 4mg PF Dexamethasone
analgesic provided in the erector spinae block is 20mL of 0.5% Bupivicaine with 4mg of PF Dexamethasone




Primary Outcome Measures :
  1. Overnight Admission Rate [ Time Frame: 24 hours ]
    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).


Secondary Outcome Measures :
  1. Narcotic for Analgesia post-operatively [ Time Frame: 14 days post-op ]
    Comparison of the percentage of patients in Groups 1 and 2 who require any narcotic for analgesia during the postoperative course following PCNL.

  2. Proportion of patients with Emergency Department return or re-admission [ Time Frame: 14 days ]
    Proportion of patient successfully discharged from PACU without return to Emergency Department or requiring re-admission within 14 days post discharge.

  3. Number of Narcotic administrations post-operatively [ Time Frame: 14 days ]
    Of patients requiring narcotics during the hospitalization, how many administrations of narcotics did these patients receive

  4. Number of Morphine Equivalents post-operatively [ Time Frame: 14 days ]
    Of patients requiring narcotics during the hospitalization, how many administrations of narcotics did these patients receive in daily morphine equivalents

  5. Number of complications peri and post-operatively [ Time Frame: 24 hours ]
    Any complications (according to Clavien-Dindo classification11) during the surgery and postoperative hospital stay

  6. Pain Score [ Time Frame: 24 hours ]
    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.

  7. Rate of Adjunct Analgesics Post-operatively [ Time Frame: 14 days ]

    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04663269


Locations
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United States, Indiana
Methodist University
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Tim Large, MD Indiana University
Publications:

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Responsible Party: Tim Large, Assistant Professor of Urology, Indiana University
ClinicalTrials.gov Identifier: NCT04663269    
Other Study ID Numbers: 87943342
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents