Liver TransplantationNCT07233096
Rectus-Intercostal Fascial Plane Block for Liver Transplantation Donors
A study testing Rectus Intercostal Plane Block in people with Liver Transplantation and Living Donor, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative pain control plays a crucial role in enhancing recovery and improving early mobilization in living liver donors. The rectus-intercostal fascial plane (RIFP) block is a novel ultrasound-guided regional anesthesia technique that provides anterior abdominal wall analgesia by targeting the intercostal nerves… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Transplantation, Living Donor, Postoperative Pain
- What is being tested?
- Rectus Intercostal Plane Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Dec 2025to 15 Jun 2026
- 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: Evaluation of Postoperative Analgesic Efficacy of Ultrasound-Guided Rectus-Intercostal Fascial Plane Block in Living Liver Donors
Postoperative pain control plays a crucial role in enhancing recovery and improving early mobilization in living liver donors. The rectus-intercostal fascial plane (RIFP) block is a novel ultrasound-guided regional anesthesia technique that provides anterior abdominal wall analgesia by targeting the intercostal nerves between the rectus abdominis and intercostal muscle fascia.
This prospective, randomized controlled clinical study aims to evaluate the postoperative analgesic efficacy and opioid-sparing effects of the RIFP block compared with standard intravenous analgesia in living liver donors undergoing donor hepatectomy.
Read more
Participants will be randomly assigned to two groups:
Group 1 (RIFP Block): Patients receiving an ultrasound-guided rectus-intercostal fascial plane block using 20 mL of 0.25% bupivacaine at the end of surgery, in addition to standard IV PCA (morphine).
Group 2 (Control): Patients receiving only standard IV PCA (morphine) without regional block.
Read the detailed description
This prospective randomized controlled study will include living liver donors undergoing donor hepatectomy. Participants will be divided into two groups: the Rectus-Intercostal Fascial Plane (RIFP) Block Group and the Control Group.
In the RIFP group, patients will receive an ultrasound-guided RIFP block at the end of surgery and postoperative analgesia with intravenous morphine PCA. The control group will receive only intravenous morphine PCA without any regional block.
The primary outcome is total morphine consumption during the first 24 postoperative hours.
Secondary outcomes include pain scores at 1, 6, 12, and 24 hours, time to first rescue analgesia, amount of rescue analgesic used, and incidence of postoperative nausea and vomiting.
This study aims to evaluate the postoperative analgesic efficacy and opioid-sparing effect of the RIFP block in living liver donors compared with standard intravenous analgesia.
- Conditions
- Liver Transplantation, Living Donor, Postoperative Pain
- Being tested
- Rectus Intercostal Plane Block, Control (No 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.
Rectus Intercostal Plane BlockOther
Rectus intercostal plane block will be administered bilaterally at the end of the surgery and after skin closure under ultrasound guidance
Control (No Block)Other
Ultrasound probe placement on the same region without needle insertion or local anesthetic injection to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| Rectus Intercostal Plane Block Group | Active comparator | Rectus Intercostal Plane Block Group The patients in the Rectus Intercostal Plane Block group will receive a bilateral rectus intercostal plane block and patient-controlled analgesia (PCA) with morphine for postoperative analgesia. Receives: Other: Rectus Intercostal Plane Block |
| Control Group | Active comparator | The patients in the Control group will not receive any regional block and will receive PCA with morphine for postoperative analgesia. Receives: Other: Control (No 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 posted18 Nov 2025
- Study start22 Dec 2025
- Primary completion15 May 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233096
- Sponsor's protocol ID
- anestezi 6
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Analgesic Efficacy of Ultrasound-Guided Rectus-Intercostal Fascial Plane Block in Living Liver Donors
- ClinicalTrials.gov ID
- NCT07233096
- Acronym / sponsor ID
- anestezi 6
- Conditions
- Liver Transplantation, Living Donor, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 18 Nov 2025 (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 control plays a crucial role in enhancing recovery and improving early mobilization in living liver donors. The rectus-intercostal fascial plane (RIFP) block is a novel ultrasound-guided regional anesthesia technique that provides anterior abdominal wall analgesia by targeting the intercostal nerves between the rectus abdominis and intercostal muscle fascia.
This prospective, randomized controlled clinical study aims to evaluate the postoperative analgesic efficacy and opioid-sparing effects of the RIFP block compared with standard intravenous analgesia in living liver donors undergoing donor hepatectomy.
Participants will be randomly assigned to two groups:
Group 1 (RIFP Block): Patients receiving an ultrasound-guided rectus-intercostal fascial plane block using 20 mL of 0.25% bupivacaine at the end of surgery, in addition to standard IV PCA (morphine).
Group 2 (Control): Patients receiving only standard IV PCA (morphine) without regional block.
Detailed description
This prospective randomized controlled study will include living liver donors undergoing donor hepatectomy. Participants will be divided into two groups: the Rectus-Intercostal Fascial Plane (RIFP) Block Group and the Control Group.
In the RIFP group, patients will receive an ultrasound-guided RIFP block at the end of surgery and postoperative analgesia with intravenous morphine PCA. The control group will receive only intravenous morphine PCA without any regional block.
The primary outcome is total morphine consumption during the first 24 postoperative hours.
Secondary outcomes include pain scores at 1, 6, 12, and 24 hours, time to first rescue analgesia, amount of rescue analgesic used, and incidence of postoperative nausea and vomiting.
This study aims to evaluate the postoperative analgesic efficacy and opioid-sparing effect of the RIFP block in living liver donors compared with standard intravenous analgesia.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectus Intercostal Plane Block Group | Active comparator | Other: Rectus Intercostal Plane BlockRectus Intercostal Plane Block Group The patients in the Rectus Intercostal Plane Block group will receive a bilateral rectus intercostal plane block and patient-controlled analgesia (PCA) with morphine for postoperative analgesia. |
| Control Group | Active comparator | Other: Control (No Block)The patients in the Control group will not receive any regional block and will receive PCA 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 |
|---|---|---|
| Rectus Intercostal Plane BlockRectus intercostal plane block will be administered bilaterally at the end of the surgery and after skin closure under ultrasound guidance | Other | Rectus Intercostal Plane Block Group |
| Control (No Block)Ultrasound probe placement on the same region without needle insertion or local anesthetic injection to maintain blinding. | Other | Control 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 25 Jun 2026.
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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 Rectus Intercostal Plane Block in people with Liver Transplantation and Living 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 25 Jun 2026. 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?
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 25 Jun 2026.