Paravertebral Block for Percutaneous Nephrolithotomy (PRONE)

Paravertebral Block for Percutaneous Nephrolithotomy (PRONE)

This study will compare post-operative pain levels in patients who receive paravertebral block prior to Percutaneous Nephrolithotomy (PCNL) surgery versus those who do not receive the block. We hypothesize that patients who receive the block will have lower post-operative pain scores and require less narcotics.

Study Overview

• Status: Unknown
• Conditions: Post Operative Pain
• Intervention / Treatment: Other: Group B- No block; Drug: Group A-Paravertebral block

Detailed Description

The strategies used to manage nephrolithiasis including medical expulsive therapy, extracorporeal shock wave (ESWL), ureteroscopy, open surgery and percutaneous nephrolithotomy (PCNL). PCNL in an inpatient procedure performed in two steps. Step 1, is the placement of a drainage line (nephrostomy tube) from the back into the collecting system of the kidney. This step is typically performed by interventional radiologists under conscious sedation. Step 2 is performed by urologists and involves dilating the tract of the nephrostomy tube, placement of an access sheath and actual removal of the stone using endoscopic equipment. The minimally invasive approach of PCNL is well accepted to be as effective as open procedures for stone removal with less morbidity. Post-operative pain management remains challenging and can lead to extended hospital stays.

This randomized, double-blinded trial designed to assess the effects of paravertebral block on intra-operative and post-operative pain control.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Consent to undergo percutaneous nephrolithotomy
• Between the ages of 18 and 75
• Able to consent, fill out study documents, and complete all study procedures and follow-up visits

Exclusion Criteria:

• Will have bilateral percutaneous nephrolithotomy
• Have an infection at the site of the proposed block
• Have anatomy that prevents ability to perform block
• Have a coagulopathy which may increase their chances of bleeding from the block
• Have a known allergy to local anesthetics
• Are unable to fill out the VAS scale due to physical or mental conditions
• Are unable to use a patient controlled analgesia (PCA) device due to physical or mental conditions
• Are pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group B- No Block; Participants randodmized to this arm will have a local anesthetic injection and pressure applied to the paravertebral space. A paravertebral injection will not be conducted.	Other: Group B- No block; direct pressure for 5 minutes will be held at the site of the where the local anesthetic was applied to mimic the application of the block.; Other Names: Placebo Group
Active Comparator: Group A- Paravertebral block; Participants randodmized to this arm will have a local anesthetic (Bupivicaine 0.5% without epinephrine) injection and will be given a paravetebral block into the T10 paravertebral space..	Drug: Group A-Paravertebral block; Bupivicaine 0.5% without epinephrine (100mg)20cc will be injected into the T10 paravertebral space. Active Group; Other Names: Group A-Paravertebral block Active Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	post-operative pain will be measured by the Visual Analog Scale (VAS.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opiod Use	All patients will receive the same post-operative pain control, which does not deviate from our standard protocol for patients receiving PCNL. All patients will be immediately given a PCA in recovery. Patients allergic to morphine/dilaudid will be given a narcoticopioid substitute (that will be converted to morphine equivalents for the purpose of the study). Nurses will be allowed to administer IV boluses of morphine PRN for inadequate pain control. If four boluses did not yield adequate analgesia, fentayl 50mcg will be used until adequate pain control is achieved.	24 hours

Collaborators and Investigators

• Sponsor: Loyola University
• Investigators: Principal Investigator: Thomas Turk, Loyola Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: November 23, 2011
• First Submitted That Met QC Criteria: November 23, 2011
• First Posted (Estimate): November 28, 2011

Study Record Updates

• Last Update Posted (Actual): March 14, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: bupivacaine; Paravertebral block; Percutaneous nephrolithotomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 203648

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED