Paravertebral Block for Percutaneous Nephrolithotomy (PRONE)

Loyola University

Status: Unknown

Conditions: Post Operative Pain

Treatments: Other: Group B- No block; Drug: Group A-Paravertebral block

Study type: Interventional

Funder types: Other

Identifiers

NCT01480102

203648

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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46 participants in 2 patient groups, including a placebo group

Group B- No Block

Placebo Comparator group

Description:

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.

Treatment:

Other: Group B- No block

Group A- Paravertebral block

Active Comparator group

Description:

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..

Treatment:

Drug: Group A-Paravertebral block