Liver TransplantationNCT05890079
External Oblique Intercostal Plane Block for Liver Transplantation Donors
A study testing Subcostal transversus abdominis plane block and External oblique intercostal plane block in people with Liver Transplantation and Donor, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain management is one of the important factors to improve rehabilitation and enhance recovery. External oblique intercostal plane block may be used for abdominal wall analgesia to provide effective analgesia for abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Transplantation, Donor, Postoperative Pain
- What is being tested?
- Subcostal transversus abdominis plane block and External oblique intercostal plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 May 2023to 17 Jan 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- Patients with American Society of Anesthesiology (ASA) physical status I-II
- Patients scheduled for a living donor hepatectomy
Who cannot join
- Allergy to local anesthetics
- Coagulopathy
- Skin infection at the block area
- Advanced renal failure
- Chronic pain syndromes
- Alcohol or drug abuse
- Psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Oblique Intercostal Plane Block for Postoperative Analgesia in Living Liver Donors
Postoperative pain management is one of the important factors to improve rehabilitation and enhance recovery. External oblique intercostal plane block may be used for abdominal wall analgesia to provide effective analgesia for abdominal surgery. The aim of this study is to investigate the postoperative analgesic efficacy of external oblique intercostal plane block and subcostal transversus abdominis plane block in living liver donors.
Researchers will compare the external oblique intercostal plane block group with subcostal transversus abdominis plane block to see if the external oblique intercostal plane block is effective for postoperative analgesia in living liver donors.
Read the detailed description
Patients scheduled for living donor hepatectomy will be separated into 2 groups: Subcostal Transversus Abdominis Plane Block Group and External Oblique Intercostal Plane Block Group. Patients in Subcostal Transversus Abdominis Plane Block will be performed subcostal transversus plane block at the end of the surgery and after skin closure and received patient controlled analgesia with morphine for postoperative analgesia. Patients in External Oblique Intercostal Plane Block Group will be performed bilateral External Oblique Intercostal Plane Block at the end of the surgery and after skin closure and received patient controlled analgesia with morphine for postoperative analgesia. Morphine consumption for first postoperative 24 hours, visual analog scale scores, time to need for first rescue analgesia, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting will be recorded.
- Conditions
- Liver Transplantation, Donor, Postoperative Pain
- Being tested
- Subcostal transversus abdominis plane block, External oblique intercostal plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcostal transversus abdominis plane blockOther
External oblique intercostal plane block will be administered at the end of the surgery and after skin closure.
External oblique intercostal plane blockOther
External oblique intercostal plane block will be administered at the end of the surgery and after skin closure. .
| Study group | Role | What they receive |
|---|---|---|
| Subcostal transversus abdominis plane block group | Active comparator | The patients in subcostal transversus abdominis plane block group will be received subcostal transversus abdominis plane block and patient controlled analgesia with morphine for postoperative analgesia Receives: Other: Subcostal transversus abdominis plane block |
| External oblique intercostal plane block group | Active comparator | The patients in External oblique intercostal plane block group will be received external oblique intercostal plane block and patient controlled analgesia with morphine for postoperative analgesia Receives: Other: External oblique intercostal plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
The amount of morphine required by the patient and given by the device will be recorded for the first 24 hours.
Measured: Postoperative 24 hours
Secondary outcomes (3)
Postoperative visual analog scale scores
Postoperative pain will be assessed using a visual analog scale (VAS) (from 0 = no pain to 10 = maximum possible pain) for the first 24 hours.
Measured: Postoperative 24 hours
Rescue analgesic drug consumption
The amount of rescue analgesic in mg required by the patient will be recorded for the first 24 hours.
Measured: postoperative 24 hours
Incidence of postoperative nausea and vomiting
Number of patients developing postoperative nausea and vomiting will be recorded for the first 24 hours
Measured: postoperative 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 Jun 2023
- Study start8 May 2023
- Primary completion14 Dec 2023
- Study completion17 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Istinye 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taylan Sahin, M.D., Principal investigator, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890079
- Sponsor's protocol ID
- anestezi2
- Status last verified
- May 2023
- First submitted
- 25 May 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sahin T, Kavakli AS, Eren E, Aydin A, Sahin NK, Tokac M, Dinckan A. Ultrasound-guided external oblique intercostal plane block versus subcostal transversus abdominis plane block for postoperative analgesia in living liver donors: A prospective randomized trial. J Clin Anesth. 2025 Sep;106:111971. doi: 10.1016/j.jclinane.2025.111971. Epub 2025 Aug 19.
PubMed 40840080
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Oblique Intercostal Plane Block for Postoperative Analgesia in Living Liver Donors
- ClinicalTrials.gov ID
- NCT05890079
- Acronym / sponsor ID
- anestezi2
- Conditions
- Liver Transplantation, Donor, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 6 Jun 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.
Postoperative pain management is one of the important factors to improve rehabilitation and enhance recovery. External oblique intercostal plane block may be used for abdominal wall analgesia to provide effective analgesia for abdominal surgery. The aim of this study is to investigate the postoperative analgesic efficacy of external oblique intercostal plane block and subcostal transversus abdominis plane block in living liver donors.
Researchers will compare the external oblique intercostal plane block group with subcostal transversus abdominis plane block to see if the external oblique intercostal plane block is effective for postoperative analgesia in living liver donors.
Detailed description
Patients scheduled for living donor hepatectomy will be separated into 2 groups: Subcostal Transversus Abdominis Plane Block Group and External Oblique Intercostal Plane Block Group. Patients in Subcostal Transversus Abdominis Plane Block will be performed subcostal transversus plane block at the end of the surgery and after skin closure and received patient controlled analgesia with morphine for postoperative analgesia. Patients in External Oblique Intercostal Plane Block Group will be performed bilateral External Oblique Intercostal Plane Block at the end of the surgery and after skin closure and received patient controlled analgesia with morphine for postoperative analgesia. Morphine consumption for first postoperative 24 hours, visual analog scale scores, time to need for first rescue analgesia, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting will be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcostal transversus abdominis plane block group | Active comparator | Other: Subcostal transversus abdominis plane blockThe patients in subcostal transversus abdominis plane block group will be received subcostal transversus abdominis plane block and patient controlled analgesia with morphine for postoperative analgesia |
| External oblique intercostal plane block group | Active comparator | Other: External oblique intercostal plane blockThe patients in External oblique intercostal plane block group will be received external oblique intercostal plane block and patient controlled analgesia with morphine for postoperative analgesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 75 years
- Patients with American Society of Anesthesiology (ASA) physical status I-II
- Patients scheduled for a living donor hepatectomy
Key exclusion criteria (7 listed)
- Allergy to local anesthetics
- Coagulopathy
- Skin infection at the block area
- Advanced renal failure
- Chronic pain syndromes
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 |
|---|---|---|
| Subcostal transversus abdominis plane blockExternal oblique intercostal plane block will be administered at the end of the surgery and after skin closure. | Other | Subcostal transversus abdominis plane block group |
| External oblique intercostal plane blockExternal oblique intercostal plane block will be administered at the end of the surgery and after skin closure. . | Other | External oblique intercostal plane block group |
Primary outcome
Morphine consumption
Time frame: Postoperative 24 hours
The amount of morphine required by the patient and given by the device will be recorded for the first 24 hours.
3 secondary outcomes
Postoperative visual analog scale scores
Time frame: Postoperative 24 hours
Rescue analgesic drug consumption
Time frame: postoperative 24 hours
Incidence of postoperative nausea and vomiting
Time frame: postoperative 24 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 19 Mar 2024.
- Derived from this study: PubMed 40840080Sahin T, Kavakli AS, Eren E, Aydin A, Sahin NK, Tokac M, Dinckan A. Ultrasound-guided external oblique intercostal plane block versus subcostal transversus abdominis plane block for postoperative analgesia in living liver donors: A prospective randomized trial. J Clin Anesth. 2025 Sep;106:111971. doi: 10.1016/j.jclinane.2025.111971. Epub 2025 Aug 19.
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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.
Taylan Sahin, M.D. principal investigator
Istinye 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 Subcostal transversus abdominis plane block and External oblique intercostal plane block in people with Liver Transplantation and Donor, run by Istinye 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 7 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 19 Mar 2024. 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?
Morphine 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?
On the ClinicalTrials.gov record for NCT05890079, which also lists 1 linked publication.
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 19 Mar 2024.