Paravertebral Block for Percutaneous Nephrolithotomy (PRONE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Loyola University
Sponsor:
Information provided by (Responsible Party):
Elizabeth Mueller, Loyola University
ClinicalTrials.gov Identifier:
NCT01480102
First received: November 23, 2011
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Post Operative Pain
Drug: Group A-Paravertebral block
Other: Group B- No block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Paravertebral Block for Percutaneous Nephrolithotomy (PRONE)

Further study details as provided by Loyola University:

Primary Outcome Measures:
  • Pain Score [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    post-operative pain will be measured by the Visual Analog Scale (VAS.


Secondary Outcome Measures:
  • Opiod Use [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 82
Study Start Date: August 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Active Comparator: Group A- Paravertebral block
Participants randodmized to this arm will have a local anesthetic injection and will be given a paravetebral block.
Drug: Group A-Paravertebral block
Bupivicaine 0.5% without epinephrine (100mg)20cc will be injected into the T10 paravertebral space.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480102

Contacts
Contact: Elizabeth Mueller, MD 708-216-2180 emuelle@lumc.edu

Locations
United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Elizabeth Mueller, MD    708-216-2180    emuelle@lumc.edu   
Sponsors and Collaborators
Loyola University
Investigators
Principal Investigator: Elizabeth Mueller, MD Loyola University
  More Information

No publications provided

Responsible Party: Elizabeth Mueller, Associate Professor, Loyola University
ClinicalTrials.gov Identifier: NCT01480102     History of Changes
Other Study ID Numbers: 203648
Study First Received: November 23, 2011
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Loyola University:
Percutaneous nephrolithotomy
Paravertebral block
bupivacaine

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014