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

Indiana University

Status and phase: Terminated; Phase 4

Conditions: Surgery; Kidney Stone

Treatments: Drug: Control Test; Drug: 4mg PF Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT04663269

87943342

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups

Control

Other group

Description:

Standard Care Protocol - peritubal block standard local analgesic administration in the form of a peritubal block

Treatment:

Drug: Control Test

ANES Block

Experimental group

Description:

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.

Treatment:

Drug: 4mg PF Dexamethasone