Clinical Trials Directory

Trials / Unknown

UnknownNCT01480102

Paravertebral Block for Percutaneous Nephrolithotomy

Paravertebral Block for Percutaneous Nephrolithotomy (PRONE)

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
46 (actual)
Sponsor
Loyola University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGGroup A-Paravertebral blockBupivicaine 0.5% without epinephrine (100mg)20cc will be injected into the T10 paravertebral space. Active Group
OTHERGroup B- No blockdirect 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.

Timeline

Start date
2011-08-01
Primary completion
2020-08-01
Completion
2021-08-01
First posted
2011-11-28
Last updated
2019-03-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01480102. Inclusion in this directory is not an endorsement.