Kidney CalculiPVBNCT03018899
Paravertebral Block Versus Epidural Anesthesia for Percutaneous Nephrolithotomy
A study testing paravertebral block and epidural anesthesia in people with Kidney Calculi, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
This prospective, randomized study is aimed to assess the efficacy and safety of paravertebral block compared to epidural anesthesia for percutaneous nephrolithotomy. The investigators suppose that paravertebral block is not inferior in controlling the perioperative pain for percutaneous nephrolithotomy compared to… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Kidney Calculi
- What is being tested?
- paravertebral block and epidural anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Jul 2017
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical statusⅠ-Ⅲ
- Undergo first stage percutaneous nephrolithotomy
- Informed consent
Who cannot join
- BMI>35
- Coagulopathy, on anticoagulants
- History of surgery on spine
- Spine deformity
- A known allergy to the drugs being used
- Tumor or infection at the site of puncture
- inability to provide adequate informed consent
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Paravertebral Block Versus Epidural Anesthesia for Surgical Anesthesia of Percutaneous Nephrolithotomy
This prospective, randomized study is aimed to assess the efficacy and safety of paravertebral block compared to epidural anesthesia for percutaneous nephrolithotomy. The investigators suppose that paravertebral block is not inferior in controlling the perioperative pain for percutaneous nephrolithotomy compared to epidural block.
Read the detailed description
Background: Percutaneous nephrolithotomy (PCNL) is generally performed under general or neuraxial anesthesia. The investigators have reported three patients who were at high risk of both general anesthesia and neuraxial anesthesia received percutaneous nephrolithotomy with ultrasound guided paravertebral block. Then，The investigators performed ultrasound guided paravertebral block for 45 patients who received percutaneous nephrolithotomy successfully. The investigators' impression is that paravertebral block is as effective as epidural anesthesia for surgical anesthesia of percutaneous nephrolithotomy.
Objectives:To assess the efficacy and safety of paravertebral block compared to epidural anesthesia for surgical anesthesia of percutaneous nephrolithotomy.
Methods: Fifty adult patients undergoing elective percutaneous nephrolithotomy will be randomized to receive ultrasound guided paravertebral block or epidural anesthesia. The primary outcome will be the pain score 12h postoperation. The secondary outcomes will include: time spent to perform block, dose of intraoperative opioids, rate of hypotension need for vasoconstrictors, muscle Power Grading of the lower legs at the end of the operation, anus exhaust time, opioid consumption postoperation, postoperative PONV score and the frequency of vomiting , hospitalization duration and patient satisfaction.
Clinical Implications: Ultrasound guided paravertebral block could be an equally effective and safe alternative to epidural block for surgical anesthesia of percutaneous nephrolithotomy.
- Conditions
- Kidney Calculi
- Being tested
- paravertebral block, epidural anesthesia
- Keywords
- paravertebral block, ultrasound, percutaneous nephrolithotomy, postoperative pain
- Medical subject headings
- Kidney Calculi, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paravertebral blockProcedure or surgery
Ultrasound guided two-segment paravertebral block
epidural anesthesiaProcedure or surgery
thoracic epidural anesthesia
| Study group | Role | What they receive |
|---|---|---|
| paravertebral block | Experimental | patients received ultrasound guided two-segment paravertebral block for percutaneous nephrolithotomy Receives: Procedure: paravertebral block |
| Epidural | Active comparator | patients received thoracic epidural anesthesia for percutaneous nephrolithotomy Receives: Procedure: epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score 12h post operation
Measured: 12 hours postoperation
Secondary outcomes (8)
time spent to perform block
Measured: during block
dose of intraoperative opioids
Measured: during operation
rate of hypotension
Measured: during operation
Muscle Power Grading of the lower legs at the end of the operation
Measured: 12 hours postoperation
opioid consumption postoperation
Measured: 12 hours postoperation
postoperative PONV score and the frequency of vomiting
Measured: 24 hours postoperation
Hospitalization duration
Measured: 10 days postoperation
Patient satisfaction
Patient satisfaction will be evaluated by 5-point Likert scal
Measured: one day before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startSep 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
- Investigators
- Wei Mei, Doctor, Study director, Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018899
- Sponsor's protocol ID
- PVB-TJ
- Acronym
- PVB
- Status last verified
- Oct 2019
- First submitted
- 13 Oct 2016
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: For patient's privacy
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Paravertebral Block Versus Epidural Anesthesia for Surgical Anesthesia of Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT03018899
- Acronym / sponsor ID
- PVB / PVB-TJ
- Conditions
- Kidney Calculi
- Keywords
- paravertebral block, ultrasound, percutaneous nephrolithotomy, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 12 Jan 2017 (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 prospective, randomized study is aimed to assess the efficacy and safety of paravertebral block compared to epidural anesthesia for percutaneous nephrolithotomy. The investigators suppose that paravertebral block is not inferior in controlling the perioperative pain for percutaneous nephrolithotomy compared to epidural block.
Detailed description
Background: Percutaneous nephrolithotomy (PCNL) is generally performed under general or neuraxial anesthesia. The investigators have reported three patients who were at high risk of both general anesthesia and neuraxial anesthesia received percutaneous nephrolithotomy with ultrasound guided paravertebral block. Then，The investigators performed ultrasound guided paravertebral block for 45 patients who received percutaneous nephrolithotomy successfully. The investigators' impression is that paravertebral block is as effective as epidural anesthesia for surgical anesthesia of percutaneous nephrolithotomy.
Objectives:To assess the efficacy and safety of paravertebral block compared to epidural anesthesia for surgical anesthesia of percutaneous nephrolithotomy.
Methods: Fifty adult patients undergoing elective percutaneous nephrolithotomy will be randomized to receive ultrasound guided paravertebral block or epidural anesthesia. The primary outcome will be the pain score 12h postoperation. The secondary outcomes will include: time spent to perform block, dose of intraoperative opioids, rate of hypotension need for vasoconstrictors, muscle Power Grading of the lower legs at the end of the operation, anus exhaust time, opioid consumption postoperation, postoperative PONV score and the frequency of vomiting , hospitalization duration and patient satisfaction.
Clinical Implications: Ultrasound guided paravertebral block could be an equally effective and safe alternative to epidural block for surgical anesthesia of percutaneous nephrolithotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paravertebral block | Experimental | Procedure: paravertebral blockpatients received ultrasound guided two-segment paravertebral block for percutaneous nephrolithotomy |
| Epidural | Active comparator | Procedure: epidural anesthesiapatients received thoracic epidural anesthesia for percutaneous nephrolithotomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists physical statusⅠ-Ⅲ
- Undergo first stage percutaneous nephrolithotomy
- Informed consent
Key exclusion criteria (8 listed)
- BMI>35
- Coagulopathy, on anticoagulants
- History of surgery on spine
- Spine deformity
- A known allergy to the drugs being used
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 blockUltrasound guided two-segment paravertebral block | Procedure or surgery | paravertebral block |
| epidural anesthesiathoracic epidural anesthesia | Procedure or surgery | Epidural |
Primary outcome
pain score 12h post operation
Time frame: 12 hours postoperation
8 secondary outcomes
time spent to perform block
Time frame: during block
dose of intraoperative opioids
Time frame: during operation
rate of hypotension
Time frame: during operation
Muscle Power Grading of the lower legs at the end of the operation
Time frame: 12 hours postoperation
opioid consumption postoperation
Time frame: 12 hours postoperation
postoperative PONV score and the frequency of vomiting
Time frame: 24 hours postoperation
Hospitalization duration
Time frame: 10 days postoperation
Patient satisfaction
Time frame: one day before discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Individual participant dataSharing planned: No. For patient's privacy
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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.
Wei Mei, Doctor study director
Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 and epidural anesthesia in people with Kidney Calculi, run by Huazhong University of Science and Technology at 1 site in China.
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 8 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: finished, as of the sponsor's last update on 30 Oct 2019. 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 China. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
pain score 12h post operation (time frame: 12 hours postoperation). 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 30 Oct 2019; AzTrials last refreshed its copy on 29 Oct 2026.