Randomized Controlled Trial Comparing the Effect of a Paravertebral Block on Pain Post Percutaneous Nephrolithotomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Opioid consumption
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A1 (PVB)
PVB technique will be utilized for injection of the anaesthetic under the skin before the procedure.
Intervention: Paravertebral Block (PVB) (Other)
A2 (Placebo)
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.
Intervention: Saline (Other)
Outcomes
Primary Outcomes
Opioid consumption
Time Frame: 24 hours post-operative, one week post-operatively
Secondary Outcomes
- 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)
Investigators
Ben Chew, MD
Associate Professor
University of British Columbia