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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01371422
Recruitment Status : Terminated (There was no resources to complete the study at this time)
First Posted : June 10, 2011
Last Update Posted : May 9, 2018
Information provided by (Responsible Party):
Ben Chew, MD, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Nephrolithiasis Other: Paravertebral Block (PVB) Other: Saline Not Applicable

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  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing the Effect of a Paravertebral Block on Pain Post Percutaneous Nephrolithotomy
Study Start Date : August 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

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

Primary Outcome Measures :
  1. Opioid consumption [ Time Frame: 24 hours post-operative, one week post-operatively ]

Secondary Outcome Measures :
  1. Postoperative pain measured by a visual analogue scale, length of hospital stay, and follow-up for the post operative course for complications [ Time Frame: 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).

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01371422

Canada, British Columbia
Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Principal Investigator: Ben Chew, MD,MSc,FRCSC University of British Columbia

Responsible Party: Ben Chew, MD, Associate Professor, University of British Columbia Identifier: NCT01371422     History of Changes
Other Study ID Numbers: H10-02017
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018

Keywords provided by Ben Chew, MD, University of British Columbia:
Paravertebral nerve blockade
Percutaneous nephrolithotomy/nephrolithotripsy

Additional relevant MeSH terms:
Kidney Calculi
Kidney Diseases
Urologic Diseases
Urinary Calculi
Pathological Conditions, Anatomical