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

Study Overview
=================
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.

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

Conditions
-----------------
Kidney Stone, Surgery

Intervention / Treatment
-----------------
* Drug: 4mg PF Dexamethasone
* Drug: Control Test


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Standard Care Protocol - peritubal block standard local analgesic administration in the form of a peritubal block | Drug: Control Test<br>* Peritubal block - standard local analgesic administration<br>* Other names: Standard of Care;|
| Experimental: ANES Block<br>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<br>* analgesic provided in the erector spinae block is 20mL of 0.5% Bupivicaine with 4mg of PF Dexamethasone<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 14 days | 
| Number of Narcotic administrations post-operatively | Of patients requiring narcotics during the hospitalization, how many administrations of narcotics did these patients receive | 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 | 14 days | 
| Number of complications peri and post-operatively | Any complications (according to Clavien-Dindo classification11) during the surgery and postoperative hospital stay | 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. | 24 hours | 
| 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) | 14 days |