Trial Comparing the Effect of a Paravertebral Block on Pain Post Percutaneous Nephrolithotomy

University of British Columbia

Status: Terminated

Conditions: Nephrolithiasis

Treatments: Other: Paravertebral Block (PVB); Other: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01371422

H10-02017

Details and patient eligibility

About

This is a randomized control trial (meaning the selection is random as when flipping a coin) to assess the benefit of paravertebral blockade (PVB) in Percutaneous nephrolithotomy/nephrolithotripsy (PCNL) surgery.

Full description

Percutaneous nephrolithotomy/nephrolithotripsy (PCNL) is an effective treatment that offers maximal physical removal of large kidney stones. However, despite the minimally invasive nature of the procedure, postoperative pain still remains a significant concern. General anaesthetic (solution given to put the patient to sleep) for the procedure is routinely given, along with a local anaesthetic injection at the operative site (injection of anaesthetic solution to the incision area to reduce the pain after the procedure) and pain pills to reduce the pain even further after surgery. Paravertebral nerve blockade (PVB) is a technique for inserting anesthetic solution into an area near the vertebrae (bony segments that form the spinal column of humans or backbone), and is an effective method for reducing pain in the post operative period from a variety of surgeries.

The investigators expect that the PVB can decrease side effects from opioids (pain medication) and other analgesics used post-operatively. Opioid side effects include nausea, vomiting, urinary retention, constipation, and drowsiness. Other side effects associated with anaesthetic use include peptic ulcer disease and acute renal failure. The investigators also expect that PVB will result in decreased post-operative pain.

Enrollment: 3 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 19 or older, able to give consent
• ASA 1, 2 or 3 patients
• Patients to undergo PCNL

Exclusion criteria

• Complex stone with anticipation of requiring >1 access sites
• Prior diagnosis of chronic pain requiring daily opioid analgesia for > 1 month prior to diagnosis of Nephrolithiasis
• Allergy to local anesthetic
• Local infection at site of regional anesthesia
• Back or other MSK deformity that contributes to inaccuracy of paravertebral block placement
• Severe cardiopulmonary disease
• Fibromyalgia
• Anticoagulation
• Patient with language barrier or inability to communicate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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3 participants in 2 patient groups, including a placebo group

A1 (PVB)

Experimental group

Description:

PVB technique will be utilized for injection of the anaesthetic under the skin before the procedure.

Treatment:

Other: Paravertebral Block (PVB)

A2 (Placebo)

Placebo Comparator group

Description:

The placebo is an inactive substance that looks identical to the test intervention but contains no active ingredients and will be administered the same as the PVB by a local skin injection, but no advancement of the needle to the paravertebral space will be made to avoid unnecessary risks.

Treatment:

Other: Saline