Percutaneous NephrolithotomyPhase 4NCT02764008
The Comparison of Low Thoracic Paravertebral Block Versus Peritubal Infiltration
A Phase 4 study testing Bupivacaine and Ultrasound in people with Percutaneous Nephrolithotomy, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Percutaneous nephrolithotomy (PCNL) is a safe and effective procedure that is considered the standard treatment for large and complex renal stones. Although it has lower complication and morbidity rates than open surgery, the pain and discomfort related to a nephrostomy tube can cause distress for patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Percutaneous Nephrolithotomy
- What is being tested?
- Bupivacaine and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2016to Aug 2016
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist's physiologic state I-III patients undergoing percutaneous nephrolithotomy
Who cannot join
- chronic pain
- bleeding disorders
- renal or hepatic insufficiency
- patients on chronic non-steroidal anti-inflammatory medications
- emergency cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Low Thoracic Paravertebral Block Versus Peritubal Infiltration in Patients Undergoing Percutaneous Nephrolithotomy
Percutaneous nephrolithotomy (PCNL) is a safe and effective procedure that is considered the standard treatment for large and complex renal stones. Although it has lower complication and morbidity rates than open surgery, the pain and discomfort related to a nephrostomy tube can cause distress for patients.
Managing this pain with opioids can lead to sedation, nausea, vomiting, and constipation, which defeat the purpose of this minimally invasive procedure.
Read more
Skin infiltration with bupivacaine around the nephrostomy tube is not effective. Infiltration of renal capsule has shown to facilitate painless insertion of nephrostomy tube, suggesting the role of renal capsule in pain management.
Peritubal infiltration of bupivacaine from renal capsule to the skin along the nephrostomy tract may alleviate postoperative pain. A unilateral Low thoracic paravertebral (PVB) block offers the option of providing extendable perioperative pain relief without the above side effects or the physiologic derangement associated with local anesthetics in the central neuraxial space.
The aim of this study is to determine whether ultrasound guided low thoracic paravertebral block effective post-operative analgesia as compared to peritubal infiltration analgesia in patients undergoing percutaneous nephrolithotomy.
Main outcome measures: The primary endpoint is postoperative opioid consumption. Secondary endpoints are visual analogue pain scores, opioid related side effects.
- Conditions
- Percutaneous Nephrolithotomy
- Being tested
- Bupivacaine, Ultrasound
- Keywords
- Postoperative Analgesia, Peritubal infiltration, Ultrasound guided low thoracic paravertebral block, Percutaneous Nephrolithotomy pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
20 ml %0,25 bupivacaine
UltrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| Low thoracic paravertebral block | Active comparator | T8-T9 Ultrasound guided paravertebral block with 20 ml %0,25 bupivacaine Receives: Drug: Bupivacaine; Device: Ultrasound |
| Peritubal infiltration | Active comparator | Peritubal infiltration with 20 ml %0,25 bupivacaine Receives: Drug: Bupivacaine |
| Control Group | No intervention | No drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Measured: First 24 hours total opioid consumption
Secondary outcomes (6)
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively.
Measured: postoperative first hour
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively.
Measured: postoperative second hour
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively
Measured: postoperative 4th hour
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively
Measured: postoperative 8th hour
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS)score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively.
Measured: postoperative 12th hour
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS)score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively
Measured: postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Percutaneous NephrolithotomyStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Murat Yayik, Ataturk University
- Investigators
- Ali Ahiskalioglu, Ass.Prof., Study director, Ataturk University Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764008
- Sponsor's protocol ID
- AUTF ANESTHESIA2
- Status last verified
- Oct 2016
- First submitted
- 4 May 2016
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kirac M, Tepeler A, Bozkurt OF, Elbir F, Ozluk C, Armagan A, Unsal A, Biri H. The efficacy of bupivacaine infiltration on the nephrostomy tract in tubeless and standard percutaneous nephrolithotomy: a prospective, randomized, multicenter study. Urology. 2013 Sep;82(3):526-31. doi: 10.1016/j.urology.2013.02.083. Epub 2013 Jul 4.
PubMed 23831069Ak K, Gursoy S, Duger C, Isbir AC, Kaygusuz K, Ozdemir Kol I, Gokce G, Mimaroglu C. Thoracic paravertebral block for postoperative pain management in percutaneous nephrolithotomy patients: a randomized controlled clinical trial. Med Princ Pract. 2013;22(3):229-33. doi: 10.1159/000345381. Epub 2012 Dec 14.
PubMed 23257888
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Low Thoracic Paravertebral Block Versus Peritubal Infiltration in Patients Undergoing Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT02764008
- Acronym / sponsor ID
- AUTF ANESTHESIA2
- Conditions
- Percutaneous Nephrolithotomy
- Keywords
- Postoperative Analgesia, Peritubal infiltration, Ultrasound guided low thoracic paravertebral block, Percutaneous Nephrolithotomy pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 May 2016 (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.
Percutaneous nephrolithotomy (PCNL) is a safe and effective procedure that is considered the standard treatment for large and complex renal stones. Although it has lower complication and morbidity rates than open surgery, the pain and discomfort related to a nephrostomy tube can cause distress for patients.
Managing this pain with opioids can lead to sedation, nausea, vomiting, and constipation, which defeat the purpose of this minimally invasive procedure.
Skin infiltration with bupivacaine around the nephrostomy tube is not effective. Infiltration of renal capsule has shown to facilitate painless insertion of nephrostomy tube, suggesting the role of renal capsule in pain management.
Peritubal infiltration of bupivacaine from renal capsule to the skin along the nephrostomy tract may alleviate postoperative pain. A unilateral Low thoracic paravertebral (PVB) block offers the option of providing extendable perioperative pain relief without the above side effects or the physiologic derangement associated with local anesthetics in the central neuraxial space.
The aim of this study is to determine whether ultrasound guided low thoracic paravertebral block effective post-operative analgesia as compared to peritubal infiltration analgesia in patients undergoing percutaneous nephrolithotomy.
Main outcome measures: The primary endpoint is postoperative opioid consumption. Secondary endpoints are visual analogue pain scores, opioid related side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low thoracic paravertebral block | Active comparator | Drug: Bupivacaine, Device: UltrasoundT8-T9 Ultrasound guided paravertebral block with 20 ml %0,25 bupivacaine |
| Peritubal infiltration | Active comparator | Drug: BupivacainePeritubal infiltration with 20 ml %0,25 bupivacaine |
| Control Group | No intervention | –No drug |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologist's physiologic state I-III patients undergoing percutaneous nephrolithotomy
Key exclusion criteria (5 listed)
- chronic pain
- bleeding disorders
- renal or hepatic insufficiency
- patients on chronic non-steroidal anti-inflammatory medications
- emergency cases
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 |
|---|---|---|
| Bupivacaine20 ml %0,25 bupivacaine | Drug | Low thoracic paravertebral block, Peritubal infiltration |
| Ultrasound | Device | Low thoracic paravertebral block |
Primary outcome
Opioid consumption
Time frame: First 24 hours total opioid consumption
6 secondary outcomes
Visual analog pain score
Time frame: postoperative first hour
Visual analog pain score
Time frame: postoperative second hour
Visual analog pain score
Time frame: postoperative 4th hour
Visual analog pain score
Time frame: postoperative 8th hour
Visual analog pain score
Time frame: postoperative 12th hour
Visual analog pain score
Time frame: postoperative 24th hour
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 11 Oct 2016.
- Background: PubMed 23831069Kirac M, Tepeler A, Bozkurt OF, Elbir F, Ozluk C, Armagan A, Unsal A, Biri H. The efficacy of bupivacaine infiltration on the nephrostomy tract in tubeless and standard percutaneous nephrolithotomy: a prospective, randomized, multicenter study. Urology. 2013 Sep;82(3):526-31. doi: 10.1016/j.urology.2013.02.083. Epub 2013 Jul 4.
- Background: PubMed 23257888Ak K, Gursoy S, Duger C, Isbir AC, Kaygusuz K, Ozdemir Kol I, Gokce G, Mimaroglu C. Thoracic paravertebral block for postoperative pain management in percutaneous nephrolithotomy patients: a randomized controlled clinical trial. Med Princ Pract. 2013;22(3):229-33. doi: 10.1159/000345381. Epub 2012 Dec 14.
- 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.
Ali Ahiskalioglu, Ass.Prof. study director
Ataturk University Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine and Ultrasound in people with Percutaneous Nephrolithotomy, run by Ataturk University at 1 site in Turkey (Türkiye).
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 1 inclusion and 5 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 11 Oct 2016. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Opioid consumption (time frame: First 24 hours total opioid consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02764008, which also lists 2 linked publications.
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 11 Oct 2016.