Percutaneous NephrolithotomyNCT03897933
Erector Spinae Plane Block for Postoperative Pain in Percutaneous Nephrolithotomy Patients: a Retrospective Study
An observational study of Percutaneous Nephrolithotomy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the ability of Erector spina Plane block decrease postoperative pain and analgesia requirements in patients undergoing Percutaneous Nephrolithotomy. 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?
- Erector Spinae Plane block ( Group I) and non- blocked Group (GROUP II)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Feb 2020
- Phase
- Observational
- 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
Study population: A number of 60 patients undergoing PCNL between January 2019 and December 2019 were included in our study. Patients included in the study were those who were operated from the stone diseases.
Who may be able to join
- ASA I- ASA II Patients
Who cannot join
- history of allergy to the study medication
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the ability of Erector spina Plane block decrease postoperative pain and analgesia requirements in patients undergoing Percutaneous Nephrolithotomy.
Read the detailed description
Erector spina Plane block was performed with guided ultrasound at T10 Transverse process level would lead to adequate postoperative analgesia ,in Percutaneous Nephrolithotomy surgeries.
- Conditions
- Percutaneous Nephrolithotomy
- Being tested
- Erector Spinae Plane block ( Group I), non- blocked Group (GROUP II)
- Keywords
- Erector spinae block, percutaneous, nephrolithotomy, stone, ultrasound
- Medical subject headings
- Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane block ( Group I)Procedure or surgery
ESP Block was performed preoperative to all patients in ESP block group. Patients in all groups were provided with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
non- blocked Group (GROUP II)Procedure or surgery
This group was received no intervetion. Patients in all groups were provided with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block group (ESP) | Single- shot ultrasound guided ESP block with 30 ml 0.25% bupivacain at the T10 vertebral level was performed preoperatively to patients in the ESP group (Group I). Receives: Procedure: Erector Spinae Plane block ( Group I) | |
| non- blocked Group | consists of the patient group without any procedure Receives: Procedure: non- blocked Group (GROUP II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid consumption
In the recovery room, all patients were given a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 10 min lockout time and 10 mg 4 h limit.Total morphine consumption during the 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).
Measured: 24 hours after surgery
Verbal analog Pain Scores on rest and movement
A Research assistant, blinded to the group allocation, interviewed patients and collected data at 5 times intervals ( 2, 4, 6, 12, 24, hours) in the 24 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.
Measured: 24 hours after surgery
Secondary outcomes (2)
Demographic data
Age, BMI, ASA, Duration of surgery was recorded.
Measured: 24 hours after surgery
incidences of adverse effects (like nausea and vomiting)
incidences of nausea and vomiting during the 24 hours postoperative period was recorded recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Feb 2020
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 Percutaneous NephrolithotomyStudies of the same condition, open and under way.
- More trials run by TC Erciyes 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Seçkin Pehlivan, TC Erciyes University
- Investigators
- Sibel Pehlivan, Study director, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897933
- Sponsor's protocol ID
- 2019/881
- Status last verified
- Jan 2020
- First submitted
- 29 Mar 2019
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Liu X, Huang G, Zhong R, Hu S, Deng R. Comparison of Percutaneous Nephrolithotomy Under Regional versus General Anesthesia: A Meta-Analysis of Randomized Controlled Trials. Urol Int. 2018;101(2):132-142. doi: 10.1159/000491021. Epub 2018 Jul 20.
PubMed 30032149Elkassabany N, Ahmed M, Malkowicz SB, Heitjan DF, Isserman JA, Ochroch EA. Comparison between the analgesic efficacy of transversus abdominis plane (TAP) block and placebo in open retropubic radical prostatectomy: a prospective, randomized, double-blinded study. J Clin Anesth. 2013 Sep;25(6):459-65. doi: 10.1016/j.jclinane.2013.04.009. Epub 2013 Aug 17.
PubMed 23965191Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.
PubMed 29980005
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block for Postoperative Pain in Percutaneous Nephrolithotomy Patients: a Retrospective Study
- ClinicalTrials.gov ID
- NCT03897933
- Acronym / sponsor ID
- 2019/881
- Conditions
- Percutaneous Nephrolithotomy
- Keywords
- Erector spinae block, percutaneous, nephrolithotomy, stone, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 1 Apr 2019 (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.
To evaluate the ability of Erector spina Plane block decrease postoperative pain and analgesia requirements in patients undergoing Percutaneous Nephrolithotomy.
Detailed description
Erector spina Plane block was performed with guided ultrasound at T10 Transverse process level would lead to adequate postoperative analgesia ,in Percutaneous Nephrolithotomy surgeries.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block group (ESP) | – | Procedure: Erector Spinae Plane block ( Group I)Single- shot ultrasound guided ESP block with 30 ml 0.25% bupivacain at the T10 vertebral level was performed preoperatively to patients in the ESP group (Group I). |
| non- blocked Group | – | Procedure: non- blocked Group (GROUP II)consists of the patient group without any procedure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A number of 60 patients undergoing PCNL between January 2019 and December 2019 were included in our study. Patients included in the study were those who were operated from the stone diseases.
Key inclusion criteria (1 listed)
- ASA I- ASA II Patients
Key exclusion criteria (2 listed)
- history of allergy to the study medication
- refusal to participate
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 |
|---|---|---|
| Erector Spinae Plane block ( Group I)ESP Block was performed preoperative to all patients in ESP block group. Patients in all groups were provided with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia. | Procedure or surgery | Erector spinae plane block group (ESP) |
| non- blocked Group (GROUP II)This group was received no intervetion. Patients in all groups were provided with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia. | Procedure or surgery | non- blocked Group |
Primary outcome
opioid consumption
Time frame: 24 hours after surgery
In the recovery room, all patients were given a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 10 min lockout time and 10 mg 4 h limit.Total morphine consumption during the 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).
Verbal analog Pain Scores on rest and movement
Time frame: 24 hours after surgery
A Research assistant, blinded to the group allocation, interviewed patients and collected data at 5 times intervals ( 2, 4, 6, 12, 24, hours) in the 24 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.
2 secondary outcomes
Demographic data
Time frame: 24 hours after surgery
incidences of adverse effects (like nausea and vomiting)
Time frame: 24 hours after surgery
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 1 Aug 2022.
- Results publication: PubMed 30032149Liu X, Huang G, Zhong R, Hu S, Deng R. Comparison of Percutaneous Nephrolithotomy Under Regional versus General Anesthesia: A Meta-Analysis of Randomized Controlled Trials. Urol Int. 2018;101(2):132-142. doi: 10.1159/000491021. Epub 2018 Jul 20.
- Results publication: PubMed 23965191Elkassabany N, Ahmed M, Malkowicz SB, Heitjan DF, Isserman JA, Ochroch EA. Comparison between the analgesic efficacy of transversus abdominis plane (TAP) block and placebo in open retropubic radical prostatectomy: a prospective, randomized, double-blinded study. J Clin Anesth. 2013 Sep;25(6):459-65. doi: 10.1016/j.jclinane.2013.04.009. Epub 2013 Aug 17.
- Results publication: PubMed 29980005Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
Sibel Pehlivan study director
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Nephrolithotomy, run by TC Erciyes 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 2 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 1 Aug 2022. 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?
opioid consumption (time frame: 24 hours after surgery). The study lists 2 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 NCT03897933, 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 1 Aug 2022.