Paravertebral Block for Percutaneous Nephrolithotomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2021-08-31

Brief Summary

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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.

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Detailed Description

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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

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Group B- No block

Intervention Type OTHER

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.

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..

Group Type ACTIVE_COMPARATOR

Group A-Paravertebral block

Intervention Type DRUG

Bupivicaine 0.5% without epinephrine (100mg)20cc will be injected into the T10 paravertebral space. Active Group

Interventions

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Group A-Paravertebral block

Bupivicaine 0.5% without epinephrine (100mg)20cc will be injected into the T10 paravertebral space. Active Group

Intervention Type DRUG

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.

Intervention Type OTHER

Other Intervention Names

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Group A-Paravertebral block Active Group Placebo Group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No