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

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

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.

Study Overview

• Status: Terminated
• Conditions: Nephrolithiasis
• Intervention / Treatment: Other: Paravertebral Block (PVB); Other: Saline

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A1 (PVB); PVB technique will be utilized for injection of the anaesthetic under the skin before the procedure.	Other: Paravertebral Block (PVB); The T10, T11 and T12 paravertebral spaces on the operative side will be identified with ultrasound in all patients (Sonosite MicroMax, 2-5 MHz curvilinear probe). In the PVB group, a 90mm 22g Tuohy needle will be inserted in-plane with the live ultrasound image over the transverse process at each of these levels and 5 mL of 0.5% ropivacaine will be injected at each level.
PLACEBO_COMPARATOR: 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.	Other: Saline; Ultrasonography and local infiltration of saline will only be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Opioid consumption	24 hours post-operative, one week post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain measured by a visual analogue scale, length of hospital stay, and follow-up for the post operative course for complications	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).	1, 6, and 24 hours post-operatively

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Ben Chew, MD,MSc,FRCSC, University of British Columbia

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: February 10, 2011
• First Submitted That Met QC Criteria: June 9, 2011
• First Posted (ESTIMATE): June 10, 2011

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2018
• Last Update Submitted That Met QC Criteria: May 3, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: pain; opioids; Paravertebral nerve blockade; Percutaneous nephrolithotomy/nephrolithotripsy
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: H10-02017