ESP Block vs Control for Pain Control Following Percutaneous Nephrolithotomy

May 8, 2023 updated by: University of Tennessee Medical Center

Erector Spinae Plane Block Versus Control for Pain Control Following Percutaneous Nephrolithotomy: A Randomized, Double-Blind, Placebo Controlled Study

The purpose of this study is to investigate the use of the erector spinae (ESP) block in reducing the morphine milligram equivalent (MME) consumption post percutaneous nephrolithotomy. Objectives:

  1. - Determine if there is a significant effect on post percutaneous nephrolithotomy MME consumption with the usage of an ESP block vs. saline control.
  2. - Determine if there is a significant effect on reported pain levels with the use of an ESP block vs. saline control in post percutaneous nephrolithotomies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a double-blind, randomized control trial involving 128 subjects undergoing an elective percutaneous nephrolithotomy. All subjects who meet all inclusion and exclusion criteria will be equally randomized on the day of the procedure by operating room pharmacy into either the ESP block or the control block. An interim analysis at the sample size required for a large effect size (n = 52, with n = 26 in each treatment arm) will be performed. In order to blind the anesthesiologist performing the block, the control arm will be equally randomized by the pharmacist at the time of distributing the pre-filled syringes for the ESP block procedure. Randomization will occur with the use of a random number generator with 1:1 ESP:Control allocation ratio.

Subjects will be followed at Pre-op and the 24-h, 48-h, 7 days and 30 days post operatively to assess the quality of recovery utilizing the Quality of Recovery-15 (QoR-15) questionnaire, VAS pain scale, and opioid consumption. Intraoperative MMEs, PACU MMEs, total MME's, FLACC scores at 30 minutes/1 hour VAS scores at 1 hour/2 hours/6 hours/24 hours, PACU LOS, hospital LOS, time to first flatus will be documented in patient chart, reviewed by study personnel and uploaded into a password protected database on the UTMCK server.

All aspects of the study and consent forms will be IRB approved prior to implementation. Potential candidates will be selected for consent based on chart review and surgery scheduling.

  • The Surgeon will initially approach potential subjects and provide them with a copy of the consent form to take home and read prior to pre-anesthesia testing.
  • At the subject's pre-anesthesia testing appointment, the research staff will explain the risks and benefits of the study, answer any questions, and obtain consent to participate.
  • The Biostatistician will randomize the subjects with a random number generator. Once randomized, a blinded package labeled "ESP" or "Control" will be delivered to the regional anesthesia team containing the following:

ESP

Active group:

  1. One 30mL syringe containing 29mL of 0.5% ropivacaine and 4mg of dexamethasone- labeled "ESP Block"
  2. One 30mL syringe containing 30mL of preservative free normal saline- labeled "wound infiltration" Sham group

1. One 30mL syringe containing 30mL of 0.5% ropivacaine- labeled "wound infiltration" 2. One 30mL syringe containing 30mL of preservative free normal saline- labeled "ESP Block"

  • The pharmacist will create a table pre-populated with the randomization assignments with space to fill out patient information and medication information on the day of surgery. This chart will be in paper form and kept in a research binder in the OR pharmacy. When a patient is consented for the RCT, the treatment group will be chosen based on the numbers assigned a priori. Each qualifying patient will be documented on the subsequent row in the table, maintaining the original order of randomization as dictated by the statistician. Based on the assignment, the pharmacy technician will be instructed as to which products to make in the sterile hood. The pharmacist will verify that the products were made appropriately and will label the syringes according to assignment.
  • Operating room pharmacy will hand the anesthesiologist a blinded package with one prefilled syringe for the regional block that will either contain 30mL of 0.5% ropivacaine with 4mg of dexamethasone or preservative free normal saline.
  • The regional anesthesiologist will perform the ESP block using standard protocols and procedures.
  • Age, BMI, duration of operation, EBL, intraoperative MMEs, PACU MMEs, 48 hours post-operative MMEs, total MME's, FLACC scores at 30 minutes/1 hour VAS scores at 1 hour/2 hours/6 hours/24 hours, PACU LOS, hospital LOS, time to first flatus will be documented in patient chart and reviewed by study personnel.
  • QoR-15, MME consumption, and VAS will be assessed at Pre-op, 24-h, 48-h, 7 and 30 days by study staff. Data will be uploaded into a database kept on secured password protected computers on the UTMCK server.
  • All patient identifiers will be removed prior to data analysis.

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • University of Tennessee Medical Center
        • Contact:

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

Description

Inclusion Criteria:

  • Adults, male and female greater than or equal to 18 years of age and undergoing non-emergent percutaneous nephrolithotomy Monday through Friday between the hours of 6:00AM and 4:00PM.
  • Female participants of childbearing potential will be required to provide a negative pregnancy test.
  • Ability to understand and teach back consent for the procedure.
  • Willingness to sign consent for procedure.
  • English speaking.

Exclusion Criteria:

  • Emergent surgery status.
  • Local infection
  • Allergy to local anesthetics.
  • Recreational drug use.
  • Inability to provide informed consent.
  • Pregnancy or breastfeeding.
  • History of Guillain-Barre' Syndrome.
  • Underlying medical conditions that would post a significant risk to the patient.
  • Opioid use >90 days in the year leading up to surgery.

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
Active Comparator: ESP Group
One 30mL syringe containing 30mL of 0.5% ropivacaine and 4 mg of dexamethosone-
Procedure: Erector Spinae Plane Block
The Anesthesiologist will use ultrasound-guided technique and inject 30mL of 0.5% ropivacaine with 4 mg of dexamethasone or saline placebo control into the erector spinae muscle, superficial to the tips of the thoracic transverse processes
Drug: Ropivacaine 0.5% Injectable Solution
The Anesthesiologist will use ultrasound-guided technique and inject 30mL of 0.5% ropivacaine with 4 mg of dexamethasone or saline placebo control into the erector spinae muscle, superficial to the tips of the thoracic transverse processes
Drug: Dexamethasone
The Anesthesiologist will use ultrasound-guided technique and inject 30mL of 0.5% ropivacaine with 4 mg of dexamethasone or saline placebo control into the erector spinae muscle, superficial to the tips of the thoracic transverse processes
Sham Comparator: Sham Group
One 30mL syringe containing 30mL of preservative free normal saline
Procedure: Erector Spinae Plane Block
The Anesthesiologist will use ultrasound-guided technique and inject 30mL of 0.5% ropivacaine with 4 mg of dexamethasone or saline placebo control into the erector spinae muscle, superficial to the tips of the thoracic transverse processes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption (MME)
Time Frame: First 24 hours postoperative
Opioid consumption (MME) in the first 24 hours postoperative
First 24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital LOS
Time Frame: Number of days in hospital (inpatient) from day of surgery (day 1) until discharge post-surgery in 24 hour increments up to 30 days
Hospital length of stay
Number of days in hospital (inpatient) from day of surgery (day 1) until discharge post-surgery in 24 hour increments up to 30 days
VAS score
Time Frame: First 24 hours after surgery.
Mean Visual Analog Scale (VAS) score in the first 24 hours after surgery. VAS measures the amount of pain that a patient feels ranging across a continuum from none(0) to an extreme amount of pain(10) on a chart.
First 24 hours after surgery.
Opioid use during first 24 hours after surgery
Time Frame: 24 hours
MMEs (morphine milligram equivalent) administered during first 24 hours post surgery
24 hours
QoR-15
Time Frame: 24 hours, 48 hours, 7 days, and 30 days after surgery
Quality of Recovery -15 at 24 hours, 48 hours, 7 days, and 30 days after surgery. QoR-15 measures how a patient feels they are recovering after surgery using a 15 item survey rated 0 (none of the time-poor) to 10 (all of the time-excellent).
24 hours, 48 hours, 7 days, and 30 days after surgery
Opioid use during 30 days post hospital discharge
Time Frame: 30 days
MMEs administered/consumed during 30 day period post hospital discharge
30 days

Collaborators and Investigators

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

Sponsor

University of Tennessee Medical Center

Investigators

  • Principal Investigator: Jason Buehler, MD, University of Tennessee Medical Center

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)

August 9, 2021

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

August 2, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANES-01-072021

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

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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 Nephrolithotomy, Percutaneous

Clinical Trials on Erector Spinae Plane Block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe