Renal TransplantationNCT04863716
Erector Spinae Plane Block in Renal Transplantation Donors
A study testing Erector Spinae Plane Block in people with Renal Transplantation and Laparoscopic Nephrectomy, run by Koc University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Erector Spina Plan Block (ESPB) is a relatively new, easy-to-apply and safe regional anesthesia technique used to provide postoperative analgesia in various surgeries. Studies showing the clinical benefits of Erector Spina Plan block in renal transplantation surgery are limited to case reports. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Transplantation, Laparoscopic Nephrectomy, Erector Spinae Plane Block
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Apr 2021to 14 Apr 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Donor patients scheduled for elective nephrectomy in renal transplantation surgery
- ASA I-II
- Patients who are aged between 18-75
Who cannot join
- Skin infection at the Erector Spina Plan Block area
- Coagulation disorder or using anticoagulant drugs
- End-stage organ and system failure
- Severe pulmonary and/or cardiovascular problems
- Substance addiction or known psychiatric or mental problems
- Chronic painkiller usage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Koç University Hospital
Istanbul, Zeytinburnu, 34010
About this study
Official title: Effects of Erector Spinae Plane Block on Opioid Consumption in Renal Transplantation Donors
Erector Spina Plan Block (ESPB) is a relatively new, easy-to-apply and safe regional anesthesia technique used to provide postoperative analgesia in various surgeries. Studies showing the clinical benefits of Erector Spina Plan block in renal transplantation surgery are limited to case reports. In this study, the effect of Erector Spina Plan Block on opioid consumption in postoperative period on donor patients who will undergo laparoscopic nephrectomy in renal transplantation surgery will be examined prospectively.
The aim of the study is to provide analgesia to donor patients using less opioids by Erector Spina Plan Block and provide enhanced recovery.
- Being tested
- Erector Spinae Plane Block, Intravenous fentanyl patient control device
- Keywords
- Laparoscopic Nephrectomy, Erector Spinae Plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Erector Spinae Plane Block will be administered before the surgery.
Intravenous fentanyl patient control deviceProcedure or surgery
24-hour fentanyl consumption will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Erector Spinae Plane Block will be administered to this group. Receives: Procedure: Erector Spinae Plane Block; Procedure: Intravenous fentanyl patient control device |
| Control Group | Active comparator | No regional anesthesia technique will be applied to the control group. Receives: Procedure: Intravenous fentanyl patient control device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fentanyl consumption
The amount of fentanyl required by the patient and given by the device will be recorded for the first 24 hours.
Measured: Postoperative 24 hours
Secondary outcomes (2)
Visual Analog Scale
Pain of patients will be evaluated and recorded according to the Visual Analog Scale.
Measured: Postoperative 24 hours
Modified Aldrete Score
Modified Aldrete Score will be used in patient recovery, and scores will be recorded at 5 minute intervals.
Measured: Postoperative 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start28 Apr 2021
- Primary completion10 Apr 2022
- Study completion14 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantationStudies 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
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koc University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Özkalaycı, Koc University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863716
- Sponsor's protocol ID
- KocUniversityH
- Status last verified
- Sep 2022
- First submitted
- 20 Apr 2021
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Erector Spinae Plane Block on Opioid Consumption in Renal Transplantation Donors
- ClinicalTrials.gov ID
- NCT04863716
- Acronym / sponsor ID
- KocUniversityH
- Keywords
- Laparoscopic Nephrectomy, Erector Spinae Plane Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Koc University HospitalUniversity, hospital or other
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 10 Apr 2022 (actual)
- Study completion
- 14 Apr 2022 (actual)
- First posted
- 28 Apr 2021 (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.
Erector Spina Plan Block (ESPB) is a relatively new, easy-to-apply and safe regional anesthesia technique used to provide postoperative analgesia in various surgeries. Studies showing the clinical benefits of Erector Spina Plan block in renal transplantation surgery are limited to case reports. In this study, the effect of Erector Spina Plan Block on opioid consumption in postoperative period on donor patients who will undergo laparoscopic nephrectomy in renal transplantation surgery will be examined prospectively.
The aim of the study is to provide analgesia to donor patients using less opioids by Erector Spina Plan Block and provide enhanced recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Procedure: Erector Spinae Plane Block, Procedure: Intravenous fentanyl patient control deviceErector Spinae Plane Block will be administered to this group. |
| Control Group | Active comparator | Procedure: Intravenous fentanyl patient control deviceNo regional anesthesia technique will be applied to the control group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Donor patients scheduled for elective nephrectomy in renal transplantation surgery
- ASA I-II
- Patients who are aged between 18-75
Key exclusion criteria (6 listed)
- Skin infection at the Erector Spina Plan Block area
- Coagulation disorder or using anticoagulant drugs
- End-stage organ and system failure
- Severe pulmonary and/or cardiovascular problems
- Substance addiction or known psychiatric or mental problems
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 BlockErector Spinae Plane Block will be administered before the surgery. | Procedure or surgery | Erector Spinae Plane Block |
| Intravenous fentanyl patient control device24-hour fentanyl consumption will be recorded. | Procedure or surgery | Control Group, Erector Spinae Plane Block |
Primary outcome
Fentanyl consumption
Time frame: Postoperative 24 hours
The amount of fentanyl required by the patient and given by the device will be recorded for the first 24 hours.
2 secondary outcomes
Visual Analog Scale
Time frame: Postoperative 24 hours
Modified Aldrete Score
Time frame: Postoperative 1 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 22 Sep 2022.
- 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 study testing Erector Spinae Plane Block in people with Renal Transplantation and Laparoscopic Nephrectomy, run by Koc University 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 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 22 Sep 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?
Fentanyl consumption (time frame: Postoperative 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 22 Sep 2022.