Nephrolithotomy, PercutaneousPhase 4NCT03652103
Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy
A Phase 4 study testing Ultrasound Guided Erector Spinae Plane Block Catheterisation and Bupivacaine 0.25% Injectable Solution in people with Nephrolithotomy, Percutaneous and Anesthetics, Local, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Investigators' goal is to determine whether Erector Spinae Plane Block would provide a better analgesia, help mobilization and early discharge or increase satisfaction for patients undergoing Percutaneous Nephrolithotomy(PNL). One of the two groups will receive ESP catheterization after general anesthesia conducted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithotomy, Percutaneous, Anesthetics, Local, Nerve Block
- What is being tested?
- Ultrasound Guided Erector Spinae Plane Block Catheterisation and Bupivacaine 0.25% Injectable Solution
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2018to 15 Mar 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are scheduled for percutaneous nephrolithotomy under total intravenous anesthesia
- Patients who has informed consent for study
- Patients with American Society of Anesthesiologists Physical Status Classification(ASA) I and II
Who cannot join
- Patient's refusal to participate
- Patients under 18 years of age
- Patients who are undergoing surgery with an anesthesia technique other than total intravenous anesthesia for any reason (inhalation anesthesia, laryngeal mask application, etc.)
- Patients with known local anesthetic allergy
- Patients with Body mass index > 35
- Patients diagnosed sepsis and bacteriemia,
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- Skin infection at the injection site,
- Patients with previous spinal surgery
- History of coagulopathy or anticoagulant therapy
- Patients with uncontrolled diabetes ,
- Uncoordinated patients,
- Psychological and emotional lability,
- Surgical intervention longer than 3 hours.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bozyaka Training and Research Hospital
Karabağlar, İzmir, 35170
About this study
Official title: Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy: A Prospective, Randomized, Controlled, Single Blind Study
Investigators' goal is to determine whether Erector Spinae Plane Block would provide a better analgesia, help mobilization and early discharge or increase satisfaction for patients undergoing Percutaneous Nephrolithotomy(PNL).
One of the two groups will receive ESP catheterization after general anesthesia conducted. The other group will receive routine analgesia protocol used for PNL.
The total amount of drugs administered, pain scores(NRS) at certain time intervals and at certain events(removal of nephrostomy and pain at mobilization) will be recorded and compared.
Read the detailed description
Erector Spinae Plane Block(ESP) is a rather new method which can block ventral and dorsal rami of spinal nerves in the paravertebral area after they leave the spinal column. Originally used for thoracic somites, by spreading in a craniocaudal fashion in the erector spinae muscle group, it has the potential of blocking cervical or lumbar nerves as well.
To provide better analgesia for surgical procedures, anesthesiologists use truncal blocks for peripheral intervention. Although these blocks are generally very effective and easy to apply, they are limited by a relatively small area of effectivity. In order to achieve denser effects for larger surfaces, epidural anesthesia must be used with the risk of more severe complications than any peripheral or truncal nerve blocks. Epidural anesthesia also has the disadvantages of requiring more experience and more cautiousness than ultrasound-guided truncal blocks and risks of an undesirable temporary motor blockade. ESP block could be the answer for better regional analgesia while avoiding motor blockade and complications of epidural anesthesia.
The study will have two groups as Block Group(GB) and Control Group(GC) and two periods as during operation and 48 hours after the operation. Every participant will receive Total Intravenous Anesthesia(TIVA) and will be monitored with ECG, non-invasive blood pressure, heart rate, pulse oximeter, and Bispectral Index. Participants in GB will receive ultrasound-guided ESP block catheter after proper maintenance of anesthesia provided. The first period will be during operation. We will evaluate the administered drug amounts per kilogram for each patient. Investigators believe ESP block will help them deliver proper anesthesia with lower dosages. The second period will include postoperative 48 hours. Pain scores(NRS) will be evaluated at certain time intervals and at two critical moments between the two groups. One of the critical moment which patients fear and feel the pain most is the removal time of nephrostomy. The second moment is the first time patients start walking.
Rescue analgesia will be ordered on demand for both groups as IV 1 mg/kg tramadol. Hours and amounts of rescue analgesia administered will be recorded.
- Conditions
- Nephrolithotomy, Percutaneous, Anesthetics, Local, Nerve Block, Erector Spinae Plane Block, Pain, Postoperative, Anesthesia and Analgesia
- Being tested
- Ultrasound Guided Erector Spinae Plane Block Catheterisation, Bupivacaine 0.25% Injectable Solution
- Keywords
- Truncal Nerve Blocks, Ultrasound Guided Nerve Blocks
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Erector Spinae Plane Block CatheterisationProcedure or surgery
After receiving general anesthesia, patients will positioned prone. Before operation begins, ESP block catheter will be applied with ultrasound guidance to the same level as surgeon's incision.
Bupivacaine 0.25% Injectable SolutionDrug
Also called Marcain
Perineural Injection
| Study group | Role | What they receive |
|---|---|---|
| GCont | No intervention | Only dressing will be applied to patients without actually nerve catheter performed |
| GBlock | Experimental | Ultrasound Guided Erector Spinae Plane Block Catheter will be applied: 20ml Bupivacaine 0.25% Injectable Solution* will be administered initially.
20 ml Bupivacaine %0.25 Injectable Solution** will be administered 30 minutes before ambulation at postoperative day(POD) 0 and before removal of nephrostomy at POD 2
*10ml %0,5 Bupivacaine will be diluted with 10ml Saline solution. Receives: Procedure: Ultrasound Guided Erector Spinae Plane Block Catheterisation; Drug: Bupivacaine 0.25% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of Drugs
Amounts of drugs per kilogram per hour will be recorded
Measured: During procedure
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: 30th minute postoperatively
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: 60th minute postoperatively
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: 2nd hour postoperatively
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: 6th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: 12th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: 24th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: 48th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded during the first steps as reported by the patient according to NRS
Measured: Mobilisation at postoperative day (POD) 1
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded during the procedure as reported by the patient according to NRS
Measured: At the time of removal of nephrostomy at postoperative day (POD) 2
Secondary outcomes (2)
Opioid Consumption
Opioids(Tramadol) will be administered to patients in case demanded.
Measured: 48 hour post-operatively
Discharge
Day of the discharge
Measured: 240 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 posted29 Aug 2018
- Study start5 Sep 2018
- Primary completion10 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrolithotomy, PercutaneousStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups involved. First group will receive total intravenous anesthesia and erector spinae plane block catheter Second group will receive total intravenous anesthesia and routine analgesia protocol for percutaneous Nephrolithotomy procedures.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Uğur Bilgin, Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652103
- Sponsor's protocol ID
- ESPforPNL
- Status last verified
- Apr 2021
- First submitted
- 28 Aug 2018
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy: A Prospective, Randomized, Controlled, Single Blind Study
- ClinicalTrials.gov ID
- NCT03652103
- Acronym / sponsor ID
- ESPforPNL
- Conditions
- Nephrolithotomy, Percutaneous, Anesthetics, Local, Nerve Block, Erector Spinae Plane Block, Pain, Postoperative, Anesthesia and Analgesia
- Keywords
- Truncal Nerve Blocks, Ultrasound Guided Nerve Blocks
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 10 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 29 Aug 2018 (actual)
- 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.
Investigators' goal is to determine whether Erector Spinae Plane Block would provide a better analgesia, help mobilization and early discharge or increase satisfaction for patients undergoing Percutaneous Nephrolithotomy(PNL).
One of the two groups will receive ESP catheterization after general anesthesia conducted. The other group will receive routine analgesia protocol used for PNL.
The total amount of drugs administered, pain scores(NRS) at certain time intervals and at certain events(removal of nephrostomy and pain at mobilization) will be recorded and compared.
Detailed description
Erector Spinae Plane Block(ESP) is a rather new method which can block ventral and dorsal rami of spinal nerves in the paravertebral area after they leave the spinal column. Originally used for thoracic somites, by spreading in a craniocaudal fashion in the erector spinae muscle group, it has the potential of blocking cervical or lumbar nerves as well.
To provide better analgesia for surgical procedures, anesthesiologists use truncal blocks for peripheral intervention. Although these blocks are generally very effective and easy to apply, they are limited by a relatively small area of effectivity. In order to achieve denser effects for larger surfaces, epidural anesthesia must be used with the risk of more severe complications than any peripheral or truncal nerve blocks. Epidural anesthesia also has the disadvantages of requiring more experience and more cautiousness than ultrasound-guided truncal blocks and risks of an undesirable temporary motor blockade. ESP block could be the answer for better regional analgesia while avoiding motor blockade and complications of epidural anesthesia.
The study will have two groups as Block Group(GB) and Control Group(GC) and two periods as during operation and 48 hours after the operation. Every participant will receive Total Intravenous Anesthesia(TIVA) and will be monitored with ECG, non-invasive blood pressure, heart rate, pulse oximeter, and Bispectral Index. Participants in GB will receive ultrasound-guided ESP block catheter after proper maintenance of anesthesia provided. The first period will be during operation. We will evaluate the administered drug amounts per kilogram for each patient. Investigators believe ESP block will help them deliver proper anesthesia with lower dosages. The second period will include postoperative 48 hours. Pain scores(NRS) will be evaluated at certain time intervals and at two critical moments between the two groups. One of the critical moment which patients fear and feel the pain most is the removal time of nephrostomy. The second moment is the first time patients start walking.
Rescue analgesia will be ordered on demand for both groups as IV 1 mg/kg tramadol. Hours and amounts of rescue analgesia administered will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Two groups involved. First group will receive total intravenous anesthesia and erector spinae plane block catheter Second group will receive total intravenous anesthesia and routine analgesia protocol for percutaneous Nephrolithotomy procedures.
| Arm | Type | Receives |
|---|---|---|
| GCont | No intervention | –Only dressing will be applied to patients without actually nerve catheter performed |
| GBlock | Experimental | Procedure: Ultrasound Guided Erector Spinae Plane Block Catheterisation, Drug: Bupivacaine 0.25% Injectable SolutionUltrasound Guided Erector Spinae Plane Block Catheter will be applied: 20ml Bupivacaine 0.25% Injectable Solution* will be administered initially. 20 ml Bupivacaine %0.25 Injectable Solution** will be administered 30 minutes before ambulation at postoperative day(POD) 0 and before removal of nephrostomy at POD 2 *10ml %0,5 Bupivacaine will be diluted with 10ml Saline solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are scheduled for percutaneous nephrolithotomy under total intravenous anesthesia
- Patients who has informed consent for study
- Patients with American Society of Anesthesiologists Physical Status Classification(ASA) I and II
Key exclusion criteria (13 listed)
- Patient's refusal to participate
- Patients under 18 years of age
- Patients who are undergoing surgery with an anesthesia technique other than total intravenous anesthesia for any reason (inhalation anesthesia, laryngeal mask application, etc.)
- Patients with known local anesthetic allergy
- Patients with Body mass index > 35
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 |
|---|---|---|
| Ultrasound Guided Erector Spinae Plane Block CatheterisationAfter receiving general anesthesia, patients will positioned prone. Before operation begins, ESP block catheter will be applied with ultrasound guidance to the same level as surgeon's incision. | Procedure or surgery | GBlock |
| Bupivacaine 0.25% Injectable SolutionAlso: MarcainPerineural Injection | Drug | GBlock |
Primary outcome
Dosage of Drugs
Time frame: During procedure
Amounts of drugs per kilogram per hour will be recorded
Post-operative pain assessed by Numeric Rating Scale (NRS)
Time frame: 30th minute postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Time frame: 60th minute postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Time frame: 2nd hour postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Time frame: 6th hour postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Time frame: 12th hour postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Time frame: 24th hour postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Time frame: 48th hour postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Time frame: Mobilisation at postoperative day (POD) 1
Pain scores will be recorded during the first steps as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Time frame: At the time of removal of nephrostomy at postoperative day (POD) 2
Pain scores will be recorded during the procedure as reported by the patient according to NRS
2 secondary outcomes
Opioid Consumption
Time frame: 48 hour post-operatively
Discharge
Time frame: 240 hours post-operatively
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 23 Apr 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ultrasound Guided Erector Spinae Plane Block Catheterisation and Bupivacaine 0.25% Injectable Solution in people with Nephrolithotomy, Percutaneous and Anesthetics, Local, run by Bozyaka Training and Research Hospital 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 3 inclusion and 13 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 23 Apr 2021. 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?
Dosage of Drugs (time frame: During procedure). The study lists 10 primary outcomes in all. 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 23 Apr 2021.