Post Operative PainPRONENCT01480102
Paravertebral Block for Percutaneous Nephrolithotomy
A study testing Group A-Paravertebral block and Group B- No block in people with Post Operative Pain, run by Loyola University at 1 site in United States.
Trial summary
This study will compare post-operative pain levels in patients who receive paravertebral block prior to Percutaneous Nephrolithotomy (PCNL) surgery versus those who do not receive the block. We hypothesize that patients who receive the block will have lower post-operative pain scores and require less narcotics. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Group A-Paravertebral block and Group B- No block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Aug 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent to undergo percutaneous nephrolithotomy
- Between the ages of 18 and 75
- Able to consent, fill out study documents, and complete all study procedures and follow-up visits
Who cannot join
- Will have bilateral percutaneous nephrolithotomy
- Have an infection at the site of the proposed block
- Have anatomy that prevents ability to perform block
- Have a coagulopathy which may increase their chances of bleeding from the block
- Have a known allergy to local anesthetics
- Are unable to fill out the VAS scale due to physical or mental conditions
- Are unable to use a patient controlled analgesia (PCA) device due to physical or mental conditions
- Are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: Paravertebral Block for Percutaneous Nephrolithotomy (PRONE)
This study will compare post-operative pain levels in patients who receive paravertebral block prior to Percutaneous Nephrolithotomy (PCNL) surgery versus those who do not receive the block. We hypothesize that patients who receive the block will have lower post-operative pain scores and require less narcotics.
Read the detailed description
The strategies used to manage nephrolithiasis including medical expulsive therapy, extracorporeal shock wave (ESWL), ureteroscopy, open surgery and percutaneous nephrolithotomy (PCNL). PCNL in an inpatient procedure performed in two steps. Step 1, is the placement of a drainage line (nephrostomy tube) from the back into the collecting system of the kidney. This step is typically performed by interventional radiologists under conscious sedation. Step 2 is performed by urologists and involves dilating the tract of the nephrostomy tube, placement of an access sheath and actual removal of the stone using endoscopic equipment. The minimally invasive approach of PCNL is well accepted to be as effective as open procedures for stone removal with less morbidity. Post-operative pain management remains challenging and can lead to extended hospital stays.
This randomized, double-blinded trial designed to assess the effects of paravertebral block on intra-operative and post-operative pain control.
- Conditions
- Post Operative Pain
- Being tested
- Group A-Paravertebral block, Group B- No block
- Keywords
- Percutaneous nephrolithotomy, Paravertebral block, bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A-Paravertebral blockDrug
Also called Group A-Paravertebral block Active Group
Bupivicaine 0.5% without epinephrine (100mg)20cc will be injected into the T10 paravertebral space. Active Group
Group B- No blockOther
Also called Placebo Group
direct pressure for 5 minutes will be held at the site of the where the local anesthetic was applied to mimic the application of the block.
| Study group | Role | What they receive |
|---|---|---|
| Group B- No Block | Placebo comparator | Participants randodmized to this arm will have a local anesthetic injection and pressure applied to the paravertebral space. A paravertebral injection will not be conducted. Receives: Other: Group B- No block |
| Group A- Paravertebral block | Active comparator | Participants randodmized to this arm will have a local anesthetic (Bupivicaine 0.5% without epinephrine) injection and will be given a paravetebral block into the T10 paravertebral space.. Receives: Drug: Group A-Paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
post-operative pain will be measured by the Visual Analog Scale (VAS.
Measured: 24 hours
Secondary outcomes (1)
Opiod Use
All patients will receive the same post-operative pain control, which does not deviate from our standard protocol for patients receiving PCNL. All patients will be immediately given a PCA in recovery. Patients allergic to morphine/dilaudid will be given a narcoticopioid substitute (that will be converted to morphine equivalents for the purpose of the study). Nurses will be allowed to administer IV boluses of morphine PRN for inadequate pain control. If four boluses did not yield adequate analgesia, fentayl 50mcg will be used until adequate pain control is achieved.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2020 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Turk, Loyola University
- Investigators
- Thomas Turk, Principal investigator, Loyola Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480102
- Sponsor's protocol ID
- 203648
- Acronym
- PRONE
- Status last verified
- Mar 2019
- First submitted
- 23 Nov 2011
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paravertebral Block for Percutaneous Nephrolithotomy (PRONE)
- ClinicalTrials.gov ID
- NCT01480102
- Acronym / sponsor ID
- PRONE / 203648
- Conditions
- Post Operative Pain
- Keywords
- Percutaneous nephrolithotomy, Paravertebral block, bupivacaine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 28 Nov 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 study will compare post-operative pain levels in patients who receive paravertebral block prior to Percutaneous Nephrolithotomy (PCNL) surgery versus those who do not receive the block. We hypothesize that patients who receive the block will have lower post-operative pain scores and require less narcotics.
Detailed description
The strategies used to manage nephrolithiasis including medical expulsive therapy, extracorporeal shock wave (ESWL), ureteroscopy, open surgery and percutaneous nephrolithotomy (PCNL). PCNL in an inpatient procedure performed in two steps. Step 1, is the placement of a drainage line (nephrostomy tube) from the back into the collecting system of the kidney. This step is typically performed by interventional radiologists under conscious sedation. Step 2 is performed by urologists and involves dilating the tract of the nephrostomy tube, placement of an access sheath and actual removal of the stone using endoscopic equipment. The minimally invasive approach of PCNL is well accepted to be as effective as open procedures for stone removal with less morbidity. Post-operative pain management remains challenging and can lead to extended hospital stays.
This randomized, double-blinded trial designed to assess the effects of paravertebral block on intra-operative and post-operative pain control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B- No Block | Placebo comparator | Other: Group B- No blockParticipants randodmized to this arm will have a local anesthetic injection and pressure applied to the paravertebral space. A paravertebral injection will not be conducted. |
| Group A- Paravertebral block | Active comparator | Drug: Group A-Paravertebral blockParticipants randodmized to this arm will have a local anesthetic (Bupivicaine 0.5% without epinephrine) injection and will be given a paravetebral block into the T10 paravertebral space.. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consent to undergo percutaneous nephrolithotomy
- Between the ages of 18 and 75
- Able to consent, fill out study documents, and complete all study procedures and follow-up visits
Key exclusion criteria (8 listed)
- Will have bilateral percutaneous nephrolithotomy
- Have an infection at the site of the proposed block
- Have anatomy that prevents ability to perform block
- Have a coagulopathy which may increase their chances of bleeding from the block
- Have a known allergy to local anesthetics
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 |
|---|---|---|
| Group A-Paravertebral blockAlso: Group A-Paravertebral block Active GroupBupivicaine 0.5% without epinephrine (100mg)20cc will be injected into the T10 paravertebral space. Active Group | Drug | Group A- Paravertebral block |
| Group B- No blockAlso: Placebo Groupdirect pressure for 5 minutes will be held at the site of the where the local anesthetic was applied to mimic the application of the block. | Other | Group B- No Block |
Primary outcome
Pain Score
Time frame: 24 hours
post-operative pain will be measured by the Visual Analog Scale (VAS.
1 secondary outcome
Opiod Use
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
Thomas Turk principal investigator
Loyola Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A-Paravertebral block and Group B- No block in people with Post Operative Pain, run by Loyola University at 1 site in United States.
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: status not confirmed, as of the sponsor's last update on 14 Mar 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 United States. 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?
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?
Pain Score (time frame: 24 hours). 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 14 Mar 2019; AzTrials last refreshed its copy on 5 Nov 2026.