PainNCT07252063
Sensory Distribution and Postoperative Analgesia of Ultrasound-Guided Interfascial Plane Blocks in Living Liver Donors
An observational study of Pain, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Living liver donor hepatectomy at our institution routinely includes ultrasound-guided interfascial plane blocks as part of postoperative analgesia. Although these blocks have become increasingly used in donor hepatectomy, their cutaneous sensory distributions and block-related dermatomal coverage have not been… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- interfascial plane block and cutaneus sensory mapping
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 21 May 2026
- 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
- Adult, Older adult
Study population: The study population consists of adult living liver donors undergoing elective donor hepatectomy at a tertiary care center. All participants receive ultrasound-guided interfascial plane blocks as part of the institution's routine postoperative analgesia protocol. Eligible donors are aged 18 to 65 years, classified as ASA physical status I-II, and able to cooperate with postoperative cutaneous sensory mapping procedures. Individuals with contraindications to regional anesthesia, conditions preventing accurate sensory assessment, or those who decline participation are excluded.
Who may be able to join
- Adult living liver donors undergoing elective donor hepatectomy
- Age 18 to 65 years
- ASA physical status I-II
- Patients who have received ultrasound-guided interfascial plane blocks as part of their postoperative analgesia
- Ability to cooperate with postoperative sensory mapping procedures
- Patients who agree to participate and provide written informed consent
Who cannot join
- Patients who refuse to participate or do not provide written informed consent
- Patients who have not received any ultrasound-guided interfascial plane block
- ASA physical status > II
- Presence of surgical incisions or wound complications preventing reliable sensory mapping
- Prior major abdominal surgery that may alter cutaneous innervation patterns
- Cognitive impairment limiting the ability to cooperate with sensory testing
Show all 9Show fewer
- Known psychiatric disorders (e.g., major depression, mania, schizophrenia) that may interfere with postoperative assessment
- Local infection, skin disease, or dermatologic condition preventing accurate cutaneous mapping
- Allergy or contraindication to local anesthetics used in the block
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahcesehir Unişversity Medicalpark Goztepe hospital
Istanbul
About this study
Official title: Assessment of Sensory Block Distribution and Postoperative Analgesia Following Ultrasound-Guided Interfascial Plane Blocks in Living Liver Donors: A Prospective Observational Study
Living liver donor hepatectomy at our institution routinely includes ultrasound-guided interfascial plane blocks as part of postoperative analgesia. Although these blocks have become increasingly used in donor hepatectomy, their cutaneous sensory distributions and block-related dermatomal coverage have not been systematically evaluated, with only anecdotal reports available in the literature.
This prospective observational study aims to assess both the sensory blockade patterns and the early postoperative analgesic performance of interfascial plane blocks administered to living liver donors. Following surgery, all consenting donors receive the institution's standard block protocol. Cutaneous sensory mapping is performed in the post-anesthesia care unit (PACU) at the second postoperative hour. Pain intensity and analgesic requirements within the first 24 hours are also recorded.
The study is designed to provide objective data on the dermatomal coverage and postoperative analgesic effects of contemporary ultrasound-guided interfascial plane blocks used in living liver donor surgery.
- Conditions
- Pain
- Being tested
- interfascial plane block, patient controlled analgesia device, cutaneus sensory mapping
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interfascial plane blockOther
Ultrasound-guided interfascial plane blocks are administered at the end of surgery. Block selection and needle entry points are determined according to the surgical incision line and the location of abdominal drains. All blocks are performed under real-time ultrasound guidance using the institution's standardized protocol.
patient controlled analgesia deviceOther
Intravenous patient-controlled analgesia is initiated in the postoperative period according to the institution's standard protocol. PCA settings, opioid type, basal infusion (if applicable), and bolus doses follow routine clinical practice and are recorded for analysis. PCA use during the first 24 hours is monitored to assess postoperative analgesic requirements.
cutaneus sensory mappingOther
Cutaneous sensory mapping is performed in the post-anesthesia care unit (PACU) at the second postoperative hour. Sensory blockade is assessed using a standardized pinprick test applied radially from medial to lateral directions. The borders of the blocked and unblocked regions are marked on the skin using a UV-visible dermatographic pen. Mapping is conducted over the mid-abdominal and lateral abdominal regions, and the total cutaneous coverage areas are subsequently calculated for analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous sensory block area mapping for different regional anesthesia techniques in liver donor surgery
The cutaneous sensory block area produced by the regional anesthesia technique will be evaluated at the 120th minute post-block using a standardized pinprick test. Sensory borders will be identified radially and marked on the skin with a UV-visible marker. Each mapped region will be photographed with a calibrated reference scale placed on the skin. These images will be processed using a predefined digital template to calculate the total blocked surface area in square centimeters. The resulting measurements will be used to characterize the sensory distribution of the interfascial plane blocks in living liver donors.
Measured: At 120 minutes after block administration in the post-anesthesia care unit (PACU).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Nov 2025
- Primary completion21 May 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selma Basyigit, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252063
- Sponsor's protocol ID
- Liver mapping
- Status last verified
- May 2026
- First submitted
- 19 Nov 2025
- Last updated
- 26 May 2026
- 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sensory Block Distribution and Postoperative Analgesia Following Ultrasound-Guided Interfascial Plane Blocks in Living Liver Donors: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07252063
- Acronym / sponsor ID
- Liver mapping
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 26 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.
Living liver donor hepatectomy at our institution routinely includes ultrasound-guided interfascial plane blocks as part of postoperative analgesia. Although these blocks have become increasingly used in donor hepatectomy, their cutaneous sensory distributions and block-related dermatomal coverage have not been systematically evaluated, with only anecdotal reports available in the literature.
This prospective observational study aims to assess both the sensory blockade patterns and the early postoperative analgesic performance of interfascial plane blocks administered to living liver donors. Following surgery, all consenting donors receive the institution's standard block protocol. Cutaneous sensory mapping is performed in the post-anesthesia care unit (PACU) at the second postoperative hour. Pain intensity and analgesic requirements within the first 24 hours are also recorded.
The study is designed to provide objective data on the dermatomal coverage and postoperative analgesic effects of contemporary ultrasound-guided interfascial plane blocks used in living liver donor surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult living liver donors undergoing elective donor hepatectomy at a tertiary care center. All participants receive ultrasound-guided interfascial plane blocks as part of the institution's routine postoperative analgesia protocol. Eligible donors are aged 18 to 65 years, classified as ASA physical status I-II, and able to cooperate with postoperative cutaneous sensory mapping procedures. Individuals with contraindications to regional anesthesia, conditions preventing accurate sensory assessment, or those who decline participation are excluded.
Key inclusion criteria (6 listed)
- Adult living liver donors undergoing elective donor hepatectomy
- Age 18 to 65 years
- ASA physical status I-II
- Patients who have received ultrasound-guided interfascial plane blocks as part of their postoperative analgesia
- Ability to cooperate with postoperative sensory mapping procedures
Key exclusion criteria (9 listed)
- Patients who refuse to participate or do not provide written informed consent
- Patients who have not received any ultrasound-guided interfascial plane block
- ASA physical status > II
- Presence of surgical incisions or wound complications preventing reliable sensory mapping
- Prior major abdominal surgery that may alter cutaneous innervation patterns
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 |
|---|---|---|
| interfascial plane blockUltrasound-guided interfascial plane blocks are administered at the end of surgery. Block selection and needle entry points are determined according to the surgical incision line and the location of abdominal drains. All blocks are performed under real-time ultrasound guidance using the institution's standardized protocol. | Other | – |
| patient controlled analgesia deviceIntravenous patient-controlled analgesia is initiated in the postoperative period according to the institution's standard protocol. PCA settings, opioid type, basal infusion (if applicable), and bolus doses follow routine clinical practice and are recorded for analysis. PCA use during the first 24 hours is monitored to assess postoperative analgesic requirements. | Other | – |
| cutaneus sensory mappingCutaneous sensory mapping is performed in the post-anesthesia care unit (PACU) at the second postoperative hour. Sensory blockade is assessed using a standardized pinprick test applied radially from medial to lateral directions. The borders of the blocked and unblocked regions are marked on the skin using a UV-visible dermatographic pen. Mapping is conducted over the mid-abdominal and lateral abdominal regions, and the total cutaneous coverage areas are subsequently calculated for analysis. | Other | – |
Primary outcome
Cutaneous sensory block area mapping for different regional anesthesia techniques in liver donor surgery
Time frame: At 120 minutes after block administration in the post-anesthesia care unit (PACU).
The cutaneous sensory block area produced by the regional anesthesia technique will be evaluated at the 120th minute post-block using a standardized pinprick test. Sensory borders will be identified radially and marked on the skin with a UV-visible marker. Each mapped region will be photographed with a calibrated reference scale placed on the skin. These images will be processed using a predefined digital template to calculate the total blocked surface area in square centimeters. The resulting measurements will be used to characterize the sensory distribution of the interfascial plane blocks in living liver donors.
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 26 May 2026.
- 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?
An observational study of Pain, run by Bahçeşehir 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 6 inclusion and 9 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 26 May 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?
Cutaneous sensory block area mapping for different regional anesthesia techniques in liver donor surgery (time frame: At 120 minutes after block administration in the post-anesthesia care unit (PACU).). 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 26 May 2026.