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

Phase 4

Terminated

• Conditions: Kidney Stone; Surgery
• Interventions: Drug: 4mg PF Dexamethasone; Drug: Control Test

• Registration Number: NCT04663269
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-24
• Primary Completion: 2020-09-11
• Study Completion: 2020-09-24
• Study First Submitted: 2020-11-20
• Study First Submitted QC: 2020-12-09
• Study First Posted: 2020-12-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ANES Block	4mg PF Dexamethasone	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.
Control	Control Test	Standard Care Protocol - peritubal block standard local analgesic administration in the form of a peritubal block

Primary Outcome Measures

Name	Time	Method
Overnight Admission Rate	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

Name	Time	Method
Pain Score	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.
Narcotic for Analgesia post-operatively	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.
Number of complications peri and post-operatively	24 hours	Any complications (according to Clavien-Dindo classification11) during the surgery and postoperative hospital stay
Rate of Adjunct Analgesics Post-operatively	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)
Proportion of patients with Emergency Department return or re-admission	14 days	Proportion of patient successfully discharged from PACU without return to Emergency Department or requiring re-admission within 14 days post discharge.
Number of Narcotic administrations post-operatively	14 days	Of patients requiring narcotics during the hospitalization, how many administrations of narcotics did these patients receive
Number of Morphine Equivalents post-operatively	14 days	Of patients requiring narcotics during the hospitalization, how many administrations of narcotics did these patients receive in daily morphine equivalents

Trial Locations

Locations (1)

Methodist University; 🇺🇸 Indianapolis, Indiana, United States