Paravertebral Block for Percutaneous Nephrolithotomy

Post Operative Pain Clinical Trial

— PRONE  

Official title:

Paravertebral Block for Percutaneous Nephrolithotomy (PRONE)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01480102
• Other study ID #: 203648
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2011
• Est. completion date: August 2021

Study information

• Verified date: March 2019
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: August 2021
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Group A-Paravertebral block
Bupivicaine 0.5% without epinephrine (100mg)20cc will be injected into the T10 paravertebral space. Active Group

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.

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score	post-operative pain will be measured by the Visual Analog Scale (VAS.	24 hours
Secondary	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