Paravertebral Block for Percutaneous Nephrolithotomy (PRONE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01480102|
Recruitment Status : Recruiting
First Posted : November 28, 2011
Last Update Posted : March 30, 2017
|Condition or disease||Intervention/treatment|
|Post Operative Pain||Drug: Group A-Paravertebral block Other: Group B- No block|
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 (Clinical Trial)|
|Estimated Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Paravertebral Block for Percutaneous Nephrolithotomy (PRONE)|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||August 2017|
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 Name: 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 Name: Group A-Paravertebral block Active Group
- Pain Score [ Time Frame: 24 hours ]post-operative pain will be measured by the Visual Analog Scale (VAS.
- Opiod Use [ Time Frame: 24 hours ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01480102
|Contact: Thomas Turk, MDemail@example.com|
|Contact: Mary J Tulke, RNfirstname.lastname@example.org|
|United States, Illinois|
|Loyola University Medical Center||Recruiting|
|Maywood, Illinois, United States, 60153|
|Contact: Thomas Turk, MD 708-216-8152 email@example.com|