Clinical trial NCT01371422: Trial Comparing the Effect of a Paravertebral Block on Pain Post Percutaneous Nephrolithotomy
Official title: Randomized Controlled Trial Comparing the Effect of a Paravertebral Block on Pain Post Percutaneous Nephrolithotomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nephrolithiasis
Keywords: Paravertebral nerve blockade
Percutaneous nephrolithotomy/nephrolithotripsy
opioids
pain
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2011-06-10
Enrollment: 3
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioid consumption
timeFrame: 24 hours post-operative, one week post-operatively
Secondary outcomes:
measure: Postoperative pain measured by a visual analogue scale, length of hospital stay, and follow-up for the post operative course for complications
timeFrame: 1, 6, and 24 hours post-operatively
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Ben Chew, MD,MSc,FRCSC
role: PRINCIPAL_INVESTIGATOR
References: