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

April 21, 2021 updated by: Tim Large, Indiana University

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Methodist University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days post-op
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.
14 days
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
14 days
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
14 days
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
24 hours
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.
24 hours
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)
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Tim Large, MD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2020

Primary Completion (Actual)

September 11, 2020

Study Completion (Actual)

September 24, 2020

Study Registration Dates

First Submitted

November 20, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 23, 2021

Last Update Submitted That Met QC Criteria

April 21, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 87943342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgery

Clinical Trials on Control Test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe