NephrolithiasisNCT05845281
Comparison of Erector Spinae Plane Block and Intravenous Patient-controlled Analgesia in Percutaneous Nephrolithotomy
A study testing Bupivakain + deksametazon Adjuvant in people with Nephrolithiasis and Percutaneous, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The primary purpose of this study was to compare the effects of erector spinal plane block (ESP) and IV patient-controlled analgesia (PCA) performed to provide analgesia in percutaneous nephrolithotomy surgeries on visual analog skala (VAS), additional analgesia need, patient satisfaction and mobilization times. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nephrolithiasis, Percutaneous, Analgesia
- What is being tested?
- Bupivakain + deksametazon Adjuvant
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2022to 20 Mar 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) class I-III,
- Between 18-65 years old,
- Percutaneous nephrolithotomy surgery,
- Patients who agreed to participate in the study
Who cannot join
- Obesity (BMI≥ 35)
- Coagulopathy
- Active Infection
- Drug allergies
- Pregnancy
- 65 years and older
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Erector Spina Plane Block and Intravenous Patient-controlled Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
The primary purpose of this study was to compare the effects of erector spinal plane block (ESP) and IV patient-controlled analgesia (PCA) performed to provide analgesia in percutaneous nephrolithotomy surgeries on visual analog skala (VAS), additional analgesia need, patient satisfaction and mobilization times.
Read the detailed description
ASA I-III patients aged 18-65 years who underwent percutaneous nephrolithotomy at Van Yüzüncü Yıl University Faculty of Medicine were included in the study.
The patients were informed about the study during the preoperative evaluation. In the randomized single-blind closed-envelope study, 30 patients ineach group and a total of 60 patients were included. Standard general anesthesia procedure was applied to all patients. Standard general anesthesia procedure was applied to all patients. Perioperative hemodynamic monitoring was performed. In patients who underwent general anesthesia, after the surgical procedure was completed, after sterility was ensured for the ESP group while the patient was in the lateral position for the ESPB procedure, the linear 10-18 MHz USG probe (Esaote MyLab 30, Geneva, Italy) was placed between two transverse processes in the paramedian plane and increased from 1mg/kg to %1 at the T7 level. 20 ml of 0.5 bupivacaine (Buvasin®, Vem, Istanbul, Turkey) + 2% arrhythmic residual SF from 1mg/kg was administered. For patients in the PCA group, 200 mg of tramadol was placed in 100cc of 0.9% NaCl. Set to PCA device. A 50mg loading dose was administered 10 minutes before the patient was extubated. After extubating, a bolus dose of 20 mg was started, with a 30-minute lock-in time, and an infusion dose of 5mg/hour. The 4-hour maximum limit was set to 200 mg.
VAS score, need for additional analgesia, patient satisfaction (Likert scale), mobilization times and vital signs were recorded at 30 minutes, p1, 3, 6 and 12 hours after the operation.
- Conditions
- Nephrolithiasis, Percutaneous, Analgesia, PCA
- Being tested
- Bupivakain + deksametazon Adjuvant
- Keywords
- Percutaneous, Nephrolithotomy, Plane Block, Patient-controlled analgesia
- Medical subject headings
- Nephrolithiasis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivakain + deksametazon AdjuvantProcedure or surgery
Also called PCA, Patient Controlled Analgesia
In patients who underwent general anesthesia, after the surgical procedure was completed, after sterility was ensured for the ESP group while the patient was in the lateral position for the ESPB procedure, the linear 10-18 MHz USG probe (Esaote MyLab 30, Geneva, Italy) was placed between two transverse processes in the paramedian plane and increased from 1mg/kg to %1 at the T7 level. 20 ml of 0.5 bupivacaine (Buvasin®, Vem, Istanbul, Turkey) + 2% arrhythmic residual SF from 1mg/kg was administered. For patients in the PCA group, 200 mg of tramadol was placed in 100cc of 0.9% NaCl. Set to PCA device. A 50mg loading dose was administered 10 minutes before the patient was extubated. After extubating, a bolus dose of 20 mg was started, with a 30-minute lock-in time, and an infusion dose of 5mg/hour. The 4-hour maximum limit was set to 200 mg.
| Study group | Role | What they receive |
|---|---|---|
| Group ESP, Erector Spina Plane Block (n= 30) | Active comparator | After the surgical procedure was completed in patients who underwent general anesthesia, the necessary sterility was provided for the ESPB procedure while the patient was in the lateral position. 1mg/kg 0.5% bupivacaine + 1mg/kg 2% lidocaine was drawn into the same syringe and the volume was completed to 20 ml with normal saline. A linear 10-18 MHz USG probe was placed at the thoracic 7 level (Esaote MyLab 30, Geneva, Italy) in the paramedian plane between two transverse processes. The prepared local anesthetic drug was administered under the guidance of USG. Receives: Procedure: Bupivakain + deksametazon Adjuvant |
| Group PCA, Patient Controlled Analgesia (n= 30) | Experimental | For patients in the PCA group, 200 mg of tramadol was placed in 100cc of 0.9% NaCl. Set to PCA device. A 50mg loading dose was administered 10 minutes before the patient was extubated. After extubating, a bolus dose of 20 mg was started, with a 30-minute lock-in time, and an infusion dose of 5mg/hour. The 4-hour maximum limit was set to 200 mg. Receives: Procedure: Bupivakain + deksametazon Adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative analgesia
Visual Analog Scale score were recorded at the post operative 30 minutes, 1st, 3rd, 6th and 12th hours after the operation. High VAS score was interpreted as severe pain in patients. When the VAS score was 4 and above, additional analgesic (15 mg/kg paracetamol) was given intravenously.
Measured: 24 hours
Additional analgesic drug
When the VAS score was 4 and above, 15 mg/kg paracetamol was given intravenously. Additional analgesic drug (Paracetamol) was recorded in milligrams.
Measured: 24 hours
Patient satisfaction
Patient satisfaction was recorded using a Likert scale at the 30th minute, 1st, 3rd, 6th and 12th hours after the operation.
Patient satisfaction was scored between 1 and 5 using a Likert scale at the 30th minute, 1st, 3rd, 6th and 12th hours postoperatively. 1 point not satisfied at all, 2 points dissatisfied, 3 points not sure, 4 points satisfied, 5 points very satisfied.
Measured: 24 hours
First walking time after surgery
Mobilization status was checked and recorded at the 30th minute, 1st, 3rd, 6th and 12th hours after the surgery. We accepted the extubation time as the postoperative 0th hour. We determined the time when the patients started walking for the first time after the surgery accordingly.
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 posted6 May 2023
- Study start2 Feb 2022
- Primary completion2 Feb 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NephrolithiasisStudies 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
- Model description
- The patients weredivided in two groups. Thirty patients were assigned to each group. Standard general anesthesia procedure was applied to all patients. Perioperative hemodynamic monitoring was performed. Group ESP underwent an erector spina block after the surgical procedure. Intravenous patient-controlled analgesia with tramadol was applied to group PCA patients. VAS score, need for additional analgesia, patient satisfaction (Likert scale), mobilization times and vital signs were recorded at 30 minutes, 1th, 3th, 6th and 12th hours after the operation.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacı Yusuf Güneş, MD, Yuzuncu Yil University
- Investigators
- Hacı Yusuf YG Güneş, Assist.prof, Principal investigator, Van Yüzüncü Yıl University Van, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845281
- Sponsor's protocol ID
- 02.03. 2022/04
- Status last verified
- Oct 2023
- First submitted
- 12 Apr 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and statistical analysis plan will be share for other resarchers.
Publications
Liu Y, Zhu W, Zeng G. Percutaneous nephrolithotomy with suction: is this the future? Curr Opin Urol. 2021 Mar 1;31(2):95-101. doi: 10.1097/MOU.0000000000000854.
PubMed 33470685Zeng G, Cai C, Duan X, Xu X, Mao H, Li X, Nie Y, Xie J, Li J, Lu J, Zou X, Mo J, Li C, Li J, Wang W, Yu Y, Fei X, Gu X, Chen J, Kong X, Pang J, Zhu W, Zhao Z, Wu W, Sun H, Liu Y, la Rosette J. Mini Percutaneous Nephrolithotomy Is a Noninferior Modality to Standard Percutaneous Nephrolithotomy for the Management of 20-40mm Renal Calculi: A Multicenter Randomized Controlled Trial. Eur Urol. 2021 Jan;79(1):114-121. doi: 10.1016/j.eururo.2020.09.026. Epub 2020 Sep 29.
PubMed 32994063Deng W, Hou XM, Zhou XY, Zhou QH. Rhomboid intercostal block combined with sub-serratus plane block versus rhomboid intercostal block for postoperative analgesia after video-assisted thoracoscopic surgery: a prospective randomized-controlled trial. BMC Pulm Med. 2021 Feb 25;21(1):68. doi: 10.1186/s12890-021-01432-7.
PubMed 33632189
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Erector Spina Plane Block and Intravenous Patient-controlled Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT05845281
- Acronym / sponsor ID
- 02.03. 2022/04
- Conditions
- Nephrolithiasis, Percutaneous, Analgesia, PCA
- Keywords
- Percutaneous, Nephrolithotomy, Plane Block, Patient-controlled analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 6 May 2023 (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.
The primary purpose of this study was to compare the effects of erector spinal plane block (ESP) and IV patient-controlled analgesia (PCA) performed to provide analgesia in percutaneous nephrolithotomy surgeries on visual analog skala (VAS), additional analgesia need, patient satisfaction and mobilization times.
Detailed description
ASA I-III patients aged 18-65 years who underwent percutaneous nephrolithotomy at Van Yüzüncü Yıl University Faculty of Medicine were included in the study.
The patients were informed about the study during the preoperative evaluation. In the randomized single-blind closed-envelope study, 30 patients ineach group and a total of 60 patients were included. Standard general anesthesia procedure was applied to all patients. Standard general anesthesia procedure was applied to all patients. Perioperative hemodynamic monitoring was performed. In patients who underwent general anesthesia, after the surgical procedure was completed, after sterility was ensured for the ESP group while the patient was in the lateral position for the ESPB procedure, the linear 10-18 MHz USG probe (Esaote MyLab 30, Geneva, Italy) was placed between two transverse processes in the paramedian plane and increased from 1mg/kg to %1 at the T7 level. 20 ml of 0.5 bupivacaine (Buvasin®, Vem, Istanbul, Turkey) + 2% arrhythmic residual SF from 1mg/kg was administered. For patients in the PCA group, 200 mg of tramadol was placed in 100cc of 0.9% NaCl. Set to PCA device. A 50mg loading dose was administered 10 minutes before the patient was extubated. After extubating, a bolus dose of 20 mg was started, with a 30-minute lock-in time, and an infusion dose of 5mg/hour. The 4-hour maximum limit was set to 200 mg.
VAS score, need for additional analgesia, patient satisfaction (Likert scale), mobilization times and vital signs were recorded at 30 minutes, p1, 3, 6 and 12 hours after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The patients weredivided in two groups. Thirty patients were assigned to each group. Standard general anesthesia procedure was applied to all patients. Perioperative hemodynamic monitoring was performed. Group ESP underwent an erector spina block after the surgical procedure. Intravenous patient-controlled analgesia with tramadol was applied to group PCA patients. VAS score, need for additional analgesia, patient satisfaction (Likert scale), mobilization times and vital signs were recorded at 30 minutes, 1th, 3th, 6th and 12th hours after the operation.
| Arm | Type | Receives |
|---|---|---|
| Group ESP, Erector Spina Plane Block (n= 30) | Active comparator | Procedure: Bupivakain + deksametazon AdjuvantAfter the surgical procedure was completed in patients who underwent general anesthesia, the necessary sterility was provided for the ESPB procedure while the patient was in the lateral position. 1mg/kg 0.5% bupivacaine + 1mg/kg 2% lidocaine was drawn into the same syringe and the volume was completed to 20 ml with normal saline. A linear 10-18 MHz USG probe was placed at the thoracic 7 level (Esaote MyLab 30, Geneva, Italy) in the paramedian plane between two transverse processes. The prepared local anesthetic drug was administered under the guidance of USG. |
| Group PCA, Patient Controlled Analgesia (n= 30) | Experimental | Procedure: Bupivakain + deksametazon AdjuvantFor patients in the PCA group, 200 mg of tramadol was placed in 100cc of 0.9% NaCl. Set to PCA device. A 50mg loading dose was administered 10 minutes before the patient was extubated. After extubating, a bolus dose of 20 mg was started, with a 30-minute lock-in time, and an infusion dose of 5mg/hour. The 4-hour maximum limit was set to 200 mg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) class I-III,
- Between 18-65 years old,
- Percutaneous nephrolithotomy surgery,
- Patients who agreed to participate in the study
Key exclusion criteria (6 listed)
- Obesity (BMI≥ 35)
- Coagulopathy
- Active Infection
- Drug allergies
- Pregnancy
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 |
|---|---|---|
| Bupivakain + deksametazon AdjuvantAlso: PCA, Patient Controlled AnalgesiaIn patients who underwent general anesthesia, after the surgical procedure was completed, after sterility was ensured for the ESP group while the patient was in the lateral position for the ESPB procedure, the linear 10-18 MHz USG probe (Esaote MyLab 30, Geneva, Italy) was placed between two transverse processes in the paramedian plane and increased from 1mg/kg to %1 at the T7 level. 20 ml of 0.5 bupivacaine (Buvasin®, Vem, Istanbul, Turkey) + 2% arrhythmic residual SF from 1mg/kg was administered. For patients in the PCA group, 200 mg of tramadol was placed in 100cc of 0.9% NaCl. Set to PCA device. A 50mg loading dose was administered 10 minutes before the patient was extubated. After extubating, a bolus dose of 20 mg was started, with a 30-minute lock-in time, and an infusion dose of 5mg/hour. The 4-hour maximum limit was set to 200 mg. | Procedure or surgery | Group ESP, Erector Spina Plane Block (n= 30), Group PCA, Patient Controlled Analgesia (n= 30) |
Primary outcome
Post operative analgesia
Time frame: 24 hours
Visual Analog Scale score were recorded at the post operative 30 minutes, 1st, 3rd, 6th and 12th hours after the operation. High VAS score was interpreted as severe pain in patients. When the VAS score was 4 and above, additional analgesic (15 mg/kg paracetamol) was given intravenously.
Additional analgesic drug
Time frame: 24 hours
When the VAS score was 4 and above, 15 mg/kg paracetamol was given intravenously. Additional analgesic drug (Paracetamol) was recorded in milligrams.
Patient satisfaction
Time frame: 24 hours
Patient satisfaction was recorded using a Likert scale at the 30th minute, 1st, 3rd, 6th and 12th hours after the operation. Patient satisfaction was scored between 1 and 5 using a Likert scale at the 30th minute, 1st, 3rd, 6th and 12th hours postoperatively. 1 point not satisfied at all, 2 points dissatisfied, 3 points not sure, 4 points satisfied, 5 points very satisfied.
First walking time after surgery
Time frame: 24 hours
Mobilization status was checked and recorded at the 30th minute, 1st, 3rd, 6th and 12th hours after the surgery. We accepted the extubation time as the postoperative 0th hour. We determined the time when the patients started walking for the first time after the surgery accordingly.
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 10 Oct 2023.
- Background: PubMed 33470685Liu Y, Zhu W, Zeng G. Percutaneous nephrolithotomy with suction: is this the future? Curr Opin Urol. 2021 Mar 1;31(2):95-101. doi: 10.1097/MOU.0000000000000854.
- Background: PubMed 32994063Zeng G, Cai C, Duan X, Xu X, Mao H, Li X, Nie Y, Xie J, Li J, Lu J, Zou X, Mo J, Li C, Li J, Wang W, Yu Y, Fei X, Gu X, Chen J, Kong X, Pang J, Zhu W, Zhao Z, Wu W, Sun H, Liu Y, la Rosette J. Mini Percutaneous Nephrolithotomy Is a Noninferior Modality to Standard Percutaneous Nephrolithotomy for the Management of 20-40mm Renal Calculi: A Multicenter Randomized Controlled Trial. Eur Urol. 2021 Jan;79(1):114-121. doi: 10.1016/j.eururo.2020.09.026. Epub 2020 Sep 29.
- Background: PubMed 33632189Deng W, Hou XM, Zhou XY, Zhou QH. Rhomboid intercostal block combined with sub-serratus plane block versus rhomboid intercostal block for postoperative analgesia after video-assisted thoracoscopic surgery: a prospective randomized-controlled trial. BMC Pulm Med. 2021 Feb 25;21(1):68. doi: 10.1186/s12890-021-01432-7.
- Individual participant dataSharing planned: Yes. Study protocol and statistical analysis plan will be share for other resarchers.
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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.
Hacı Yusuf YG Güneş, Assist.prof principal investigator
Van Yüzüncü Yıl University Van, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivakain + deksametazon Adjuvant in people with Nephrolithiasis and Percutaneous, run by Yuzuncu Yil 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 4 inclusion and 6 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 10 Oct 2023. 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.
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?
Post operative analgesia (time frame: 24 hours). The study lists 4 primary outcomes in all. 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 NCT05845281, which also lists 3 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 10 Oct 2023.