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Paravertebral Block for Percutaneous Nephrolithotomy (PRONE)

Primary Purpose

Post Operative Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group A-Paravertebral block
Group B- No block
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring Percutaneous nephrolithotomy, Paravertebral block, bupivacaine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Loyola University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group B- No Block

Group A- Paravertebral block

Arm Description

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.

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..

Outcomes

Primary Outcome Measures

Pain Score
post-operative pain will be measured by the Visual Analog Scale (VAS.

Secondary Outcome Measures

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.

Full Information

First Posted
November 23, 2011
Last Updated
March 13, 2019
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT01480102
Brief Title
Paravertebral Block for Percutaneous Nephrolithotomy
Acronym
PRONE
Official Title
Paravertebral Block for Percutaneous Nephrolithotomy (PRONE)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Percutaneous nephrolithotomy, Paravertebral block, bupivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group B- No Block
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Group A- Paravertebral block
Arm Type
Active Comparator
Arm Description
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..
Intervention Type
Drug
Intervention Name(s)
Group A-Paravertebral block
Other Intervention Name(s)
Group A-Paravertebral block Active Group
Intervention Description
Bupivicaine 0.5% without epinephrine (100mg)20cc will be injected into the T10 paravertebral space. Active Group
Intervention Type
Other
Intervention Name(s)
Group B- No block
Other Intervention Name(s)
Placebo Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Score
Description
post-operative pain will be measured by the Visual Analog Scale (VAS.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Opiod Use
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Turk
Organizational Affiliation
Loyola Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Paravertebral Block for Percutaneous Nephrolithotomy

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