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

Phase 4TerminatedNCT04663269

Indiana University5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Kidney Stone Surgery

Interventions

4mg PF DexamethasoneDRUG

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

Control TestDRUG

Peritubal block - standard local analgesic administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Methodist University

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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).

Time frame: 24 hours

Secondary Outcomes

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.

Time frame: 14 days post-op

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.

Time frame: 14 days

Number of Narcotic administrations post-operatively

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

Time frame: 14 days

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

Time frame: 14 days

Number of complications peri and post-operatively

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

Time frame: 24 hours

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.

Data from ClinicalTrials.gov

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