NephrolithiasisNCT01371422
Trial Comparing the Effect of a Paravertebral Block on Pain Post Percutaneous Nephrolithotomy
A study testing Paravertebral Block (PVB) and Saline in people with Nephrolithiasis, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- Paravertebral Block (PVB) and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2011to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 or older, able to give consent
- ASA 1, 2 or 3 patients
- Patients to undergo PCNL
Who cannot join
- 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
Show all 9Show fewer
- Fibromyalgia
- Anticoagulation
- Patient with language barrier or inability to communicate
Trial locations and contacts
1 site in 1 country.
Canada1 site
Stone Centre, Vancouver General Hospital, Jim Pattison Pavilion
Vancouver, British Columbia
About this study
Official title: 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.
Read the 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.
- Conditions
- Nephrolithiasis
- Being tested
- Paravertebral Block (PVB), Saline
- Keywords
- Paravertebral nerve blockade, Percutaneous nephrolithotomy/nephrolithotripsy, opioids, pain
- Medical subject headings
- Nephrolithiasis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral Block (PVB)Other
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.
SalineOther
Ultrasonography and local infiltration of saline will only be performed
| Study group | Role | What they receive |
|---|---|---|
| A1 (PVB) | Experimental | PVB technique will be utilized for injection of the anaesthetic under the skin before the procedure. Receives: Other: Paravertebral Block (PVB) |
| A2 (Placebo) | Placebo comparator | 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. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Measured: 24 hours post-operative, one week post-operatively
Secondary outcomes (1)
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).
Measured: 1, 6, and 24 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: There was no resources to complete the study at this time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Chew, MD, University of British Columbia
- Investigators
- Ben Chew, MD,MSc,FRCSC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371422
- Sponsor's protocol ID
- H10-02017
- Status last verified
- May 2018
- First submitted
- 10 Feb 2011
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Effect of a Paravertebral Block on Pain Post Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT01371422
- Acronym / sponsor ID
- H10-02017
- Conditions
- Nephrolithiasis
- Keywords
- Paravertebral nerve blockade, Percutaneous nephrolithotomy/nephrolithotripsy, opioids, pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There was no resources to complete the study at this time
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A1 (PVB) | Experimental | Other: Paravertebral Block (PVB)PVB technique will be utilized for injection of the anaesthetic under the skin before the procedure. |
| A2 (Placebo) | Placebo comparator | Other: SalineThe 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19 or older, able to give consent
- ASA 1, 2 or 3 patients
- Patients to undergo PCNL
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | A1 (PVB) |
| SalineUltrasonography and local infiltration of saline will only be performed | Other | A2 (Placebo) |
Primary outcome
Opioid consumption
Time frame: 24 hours post-operative, one week post-operatively
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: There was no resources to complete the study at this time). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Chew, MD,MSc,FRCSC principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paravertebral Block (PVB) and Saline in people with Nephrolithiasis, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: There was no resources to complete the study at this time). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: 24 hours post-operative, one week post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.