Trial Comparing the Effect of a Paravertebral Block on Pain Post Percutaneous Nephrolithotomy
Primary Purpose
Nephrolithiasis
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Paravertebral Block (PVB)
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Nephrolithiasis focused on measuring Paravertebral nerve blockade, Percutaneous nephrolithotomy/nephrolithotripsy, opioids, 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
Sites / Locations
- Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A1 (PVB)
A2 (Placebo)
Arm Description
PVB technique will be utilized for injection of the anaesthetic under the skin before the procedure.
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.
Outcomes
Primary Outcome Measures
Opioid consumption
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT01371422
First Posted
February 10, 2011
Last Updated
May 3, 2018
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT01371422
Brief Title
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
There was no resources to complete the study at this time
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis
Keywords
Paravertebral nerve blockade, Percutaneous nephrolithotomy/nephrolithotripsy, opioids, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A1 (PVB)
Arm Type
Experimental
Arm Description
PVB technique will be utilized for injection of the anaesthetic under the skin before the procedure.
Arm Title
A2 (Placebo)
Arm Type
Placebo Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Paravertebral Block (PVB)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Ultrasonography and local infiltration of saline will only be performed
Primary Outcome Measure Information:
Title
Opioid consumption
Time Frame
24 hours post-operative, one week post-operatively
Secondary Outcome Measure Information:
Title
Postoperative pain measured by a visual analogue scale, length of hospital stay, and follow-up for the post operative course for complications
Description
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).
Time Frame
1, 6, and 24 hours post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Chew, MD,MSc,FRCSC
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion
City
Vancouver
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Trial Comparing the Effect of a Paravertebral Block on Pain Post Percutaneous Nephrolithotomy
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