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

Not Applicable

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
A1 (PVB)	Paravertebral Block (PVB)	PVB technique will be utilized for injection of the anaesthetic under the skin before the procedure.
A2 (Placebo)	Saline	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.

Primary Outcome Measures

Name	Time	Method
Opioid consumption	24 hours post-operative, one week post-operatively

Secondary Outcome Measures

Name	Time	Method
Postoperative pain measured by a visual analogue scale, length of hospital stay, and follow-up for the post operative course for complications	1, 6, and 24 hours post-operatively	The pain scores at each of the specific time will be compared between the PVB and no PVB arms. So we will look for differences in pain between the PVB and no-PVB group at one hour, than separately at 6 hours and than at 24 hours. Differences for each time will be looked at different time (at 1 hr than at 6 hrs than at 24 hours post-op).

Locations (1): Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion
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Vancouver, British Columbia, Canada

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