Pain, PostoperativeNCT05406388
Erector Spinae Plane Block in Liver Transplantation Donors
A study testing Erector Spinae Plane Block in people with Pain, Postoperative, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Living donor liver transplantation has become a common treatment option for patients with end-stage liver disease. Donor hepatectomy is associated with significant postoperative pain due to inverted L-shaped incision. Therefore adequate analgesia is important for recovery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- 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
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Dec 2020to 1 Aug 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
- Donor patients scheduled for elective hepatectomy in liver transplantation surgery
- ASA I-II
- Patients who are aged between 18-65
Who cannot join
- Patients who do not accept the procedure
- Skin infection at the site of Erector Spina Plan Block area
- Coagulation disorder or using anticoagulant drugs
- Known local anesthetics and opioid allergy
- Severe pulmonary and/or cardiovascular problems
- Substance addiction or known psychiatric or mental problems
- Chronic painkiller usage
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, 34070
About this study
Official title: Ultrasound-guided Bilateral Erector Spinalis Plane Block on Postoperative Pain Management in Liver Transplantation Donors
Living donor liver transplantation has become a common treatment option for patients with end-stage liver disease. Donor hepatectomy is associated with significant postoperative pain due to inverted L-shaped incision. Therefore adequate analgesia is important for recovery.
Erector Spinae Plane Block (ESPB) is a safe anesthesia technique used to provide postoperative analgesia. This study aimed to compare the novel ultrasound-guided ESPB technique with controls in terms of postoperative opioid consumption and postoperative pain control on donor patients.
- Conditions
- Pain, Postoperative
- Being tested
- Erector Spinae Plane Block, Intravenous fentanyl patient control device
- Medical subject headings
- Pain, Postoperative
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
Intravenous fentanyl patient control device 48-hour fentanyl consumption will be recorded.
Intravenous fentanyl patient control deviceProcedure or surgery
Intravenous fentanyl patient control device 48-hour fentanyl consumption will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Erector Spinae Plane Block for Postoperative Analgesia Receives: Procedure: Erector Spinae Plane Block |
| 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.
Opioid consumption
The amount of fentanyl required by the patient and given by the device will be recorded for the first 48 hours.
Measured: Change from baseline opioid consumption at postoperative 0, 2, 4, 6, 12, 24, 36 and 48 hours
Secondary outcomes (1)
Visual Analog Scale
Pain of patients will be evaluated and recorded according to the Visual Analog Scale.
Measured: Change from baseline pain scores at postoperative 0, 2, 4, 6, 12, 24, 36 and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start24 Dec 2020
- Primary completion1 May 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Medipol 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two model for this study. The first group is erector spinae plane block group. The second one is control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tumay Uludag Yanaral, Medipol University
- Investigators
- Tumay Uludag Yanaral, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406388
- Sponsor's protocol ID
- MEDIPOLU-973
- Status last verified
- Aug 2023
- First submitted
- 1 Jun 2022
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dewe G, Steyaert A, De Kock M, Lois F, Reding R, Forget P. Pain management in living related adult donor hepatectomy: feasibility of an evidence-based protocol in 100 consecutive donors. BMC Res Notes. 2018 Nov 26;11(1):834. doi: 10.1186/s13104-018-3941-1.
PubMed 30477577Chhibber A, Dziak J, Kolano J, Norton JR, Lustik S. Anesthesia care for adult live donor hepatectomy: our experiences with 100 cases. Liver Transpl. 2007 Apr;13(4):537-42. doi: 10.1002/lt.21074.
PubMed 17394151Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
PubMed 30292068El-Boghdadly K, Pawa A. The erector spinae plane block: plane and simple. Anaesthesia. 2017 Apr;72(4):434-438. doi: 10.1111/anae.13830. Epub 2017 Feb 11. No abstract available.
PubMed 28188611Hacibeyoglu G, Topal A, Arican S, Kilicaslan A, Tekin A, Uzun ST. USG guided bilateral erector spinae plane block is an effective and safe postoperative analgesia method for living donor liver transplantation. J Clin Anesth. 2018 Sep;49:36-37. doi: 10.1016/j.jclinane.2018.06.003. Epub 2018 Jun 5. No abstract available.
PubMed 29883965
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Bilateral Erector Spinalis Plane Block on Postoperative Pain Management in Liver Transplantation Donors
- ClinicalTrials.gov ID
- NCT05406388
- Acronym / sponsor ID
- MEDIPOLU-973
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 24 Dec 2020 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 6 Jun 2022 (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.
Living donor liver transplantation has become a common treatment option for patients with end-stage liver disease. Donor hepatectomy is associated with significant postoperative pain due to inverted L-shaped incision. Therefore adequate analgesia is important for recovery.
Erector Spinae Plane Block (ESPB) is a safe anesthesia technique used to provide postoperative analgesia. This study aimed to compare the novel ultrasound-guided ESPB technique with controls in terms of postoperative opioid consumption and postoperative pain control on donor patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- There are two model for this study. The first group is erector spinae plane block group. The second one is control group.
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Procedure: Erector Spinae Plane BlockErector Spinae Plane Block for Postoperative Analgesia |
| 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 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Donor patients scheduled for elective hepatectomy in liver transplantation surgery
- ASA I-II
- Patients who are aged between 18-65
Key exclusion criteria (8 listed)
- Patients who do not accept the procedure
- Skin infection at the site of Erector Spina Plan Block area
- Coagulation disorder or using anticoagulant drugs
- Known local anesthetics and opioid allergy
- Severe pulmonary and/or cardiovascular 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 BlockIntravenous fentanyl patient control device 48-hour fentanyl consumption will be recorded. | Procedure or surgery | Erector Spinae Plane Block |
| Intravenous fentanyl patient control deviceIntravenous fentanyl patient control device 48-hour fentanyl consumption will be recorded. | Procedure or surgery | Control group |
Primary outcome
Opioid consumption
Time frame: Change from baseline opioid consumption at postoperative 0, 2, 4, 6, 12, 24, 36 and 48 hours
The amount of fentanyl required by the patient and given by the device will be recorded for the first 48 hours.
1 secondary outcome
Visual Analog Scale
Time frame: Change from baseline pain scores at postoperative 0, 2, 4, 6, 12, 24, 36 and 48 hours
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 7 Aug 2023.
- Background: PubMed 30477577Dewe G, Steyaert A, De Kock M, Lois F, Reding R, Forget P. Pain management in living related adult donor hepatectomy: feasibility of an evidence-based protocol in 100 consecutive donors. BMC Res Notes. 2018 Nov 26;11(1):834. doi: 10.1186/s13104-018-3941-1.
- Background: PubMed 17394151Chhibber A, Dziak J, Kolano J, Norton JR, Lustik S. Anesthesia care for adult live donor hepatectomy: our experiences with 100 cases. Liver Transpl. 2007 Apr;13(4):537-42. doi: 10.1002/lt.21074.
- Background: PubMed 30292068Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
- Background: PubMed 28188611El-Boghdadly K, Pawa A. The erector spinae plane block: plane and simple. Anaesthesia. 2017 Apr;72(4):434-438. doi: 10.1111/anae.13830. Epub 2017 Feb 11. No abstract available.
- Background: PubMed 29883965Hacibeyoglu G, Topal A, Arican S, Kilicaslan A, Tekin A, Uzun ST. USG guided bilateral erector spinae plane block is an effective and safe postoperative analgesia method for living donor liver transplantation. J Clin Anesth. 2018 Sep;49:36-37. doi: 10.1016/j.jclinane.2018.06.003. Epub 2018 Jun 5. No abstract available.
- 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.
Tumay Uludag Yanaral principal investigator
Medipol University
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 Pain, Postoperative, run by Medipol 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 3 inclusion and 8 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 7 Aug 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?
Opioid consumption (time frame: Change from baseline opioid consumption at postoperative 0, 2, 4, 6, 12, 24, 36 and 48 hours). 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 NCT05406388, which also lists 5 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 7 Aug 2023.