Liver Transplant; ComplicationsPhase 4NCT04232904
Effect of Transversus Abdominis Plane Block on Anti-inflammatory Response
A Phase 4 study testing Transversus abdominous plane block (TAP Block) in people with Liver Transplant; Complications and Inflammatory Response, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The liver transplantation is the only treatment for end-stage liver failure. Lack of sufficient organs from the cadaver to meet the organ needs has increased the interest in a live organ donor transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Transplant; Complications, Inflammatory Response
- What is being tested?
- Transversus abdominous plane block (TAP Block)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2019to 1 Jul 2020
- Phase
- Phase 4
- 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
- liver transplant donors schedule for right hepatectomy surgery.
- aged 18-65 years,
Who cannot join
- systemic disease (such as diabetes and hypertension),
- used opioid or NSAID in the last week,
- coagulation pathology,
- a history of allergy to drugs used in the study
- refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Inonu university
Malatya, 044100
Mehmet A Erdogan, MD, +904223410660, drmalierdogan@gmail.com
About this study
Official title: Effect of Transversus Abdominis Plane Block With Bupivacaine on Anti-inflammatory Response in Living Liver Donors
The liver transplantation is the only treatment for end-stage liver failure. Lack of sufficient organs from the cadaver to meet the organ needs has increased the interest in a live organ donor transplantation. A peripheral nerve block, transversus abdominous plane block (TAP block); When combined with general anesthesia in live liver donors, it has been shown to significantly reduce perioperative and postoperative opioid consumption, provide shorter recovery time and shorten hospital stay. It has been shown that regional block techniques using local anesthetics and analgesic adjuvants modulate both local and systemic inflammatory reactions caused by surgical injury. Cytokines are important mediators of local and systemic inflammatory response including hyperalgesia after surgery. In literature, the effect of TAP block on anti-inflammatory cytokines in live liver donors was not shown. The aim of this study is to investigate the effect of bupivacaine TAP block on antiflammatory response in living liver donors.
Read the detailed description
The liver transplantation is the only treatment for end-stage liver failure. Lack of sufficient organs from the cadaver to meet the organ needs has increased the interest in a live organ donor transplantation. A peripheral nerve block, transversus abdominous plane block (TAP block); When combined with general anesthesia in live liver donors, it has been shown to significantly reduce perioperative and postoperative opioid consumption, provide shorter recovery time and shorten hospital stay.Immunological, metabolic and endocrine reactions occur due to tissue damage, pain and anesthesia caused by surgery. It has been shown that regional block techniques using local anesthetics and analgesic adjuvants modulate both local and systemic inflammatory reactions caused by surgical injury. Cytokines are important mediators of local and systemic inflammatory response including hyperalgesia after surgery. Cytokines are indispensable for wound healing and restoration of homeostasis, but usually the overactivity of either proinflammatory or anti-inflammatory cytokines damages the host. With Preemptive epidural analgesia, peripheral nerve block and thoracic epidural analgesia; postoperative pain and proinflammatory cytokines have been reduced. In literature, the effect of TAP block on anti-inflammatory cytokines in live liver donors was not shown. The aim of this study is to investigate the effect of bupivakine TAP block on antiinflammatory response in live liver donors.This prospective clinical study will performs in 72 liver transplant donors aged 18-65 years, ASA I-II, schedule for right hepatectomy surgery. Peripheral vascular access will open and blood samples will take for preoperative cytokine and bupivacaine measurements.The primary aim of this study was to investigate the effect of TAP block on the inflammatory response by cytokine level. The secondary aim of this study is to determine the plasma bupivacaine concentrations in patients undergoing TAP block and to investigate the relationship between plasma bupivacaine level and cytokine levels.
- Being tested
- Transversus abdominous plane block (TAP Block)
- Keywords
- living liver donor, TAP block, cytokine, bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominous plane block (TAP Block)Procedure or surgery
TAP block which is a peripheral nerve block preferred to postoperative pain management.
| Study group | Role | What they receive |
|---|---|---|
| TAP Block Group | Active comparator | this is study group. Receives: Procedure: Transversus abdominous plane block (TAP Block) |
| Control Group | No intervention | This patients are control group. TAP block will be not perform |
What is being measured
The primary outcome is the main question the study is designed to answer.
cytokine level (interleukine-1, interleukine-6, tumor necrosis factor)
Immunological, metabolic and endocrine reactions occur due to tissue damage, pain and anesthesia caused by surgery. Cytokines are important mediators of local and systemic inflammatory response including hyperalgesia after surgery. Cytokines are indispensable for wound healing and restoration of homeostasis, but usually the overactivity of either proinflammatory or anti-inflammatory cytokines damages the host.
Measured: Change from baseline cytokines levels at 24 hours postoperatively
Secondary outcomes (2)
correlation of plasma bupivacaine level and cytokine level
The relationship between plasma bupivacaine level and cytokine level in patients undergoing TAP block
Measured: Change from baseline correlation of plasma bupivacaine level and cytokines levels at 24 hours postoperatively
The plasma bupivacaine concentrations
The plasma bupivacaine concentrations in patients undergoing TAP block
Measured: Change from baseline plasma bupivacaine concentrations at 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start2 Dec 2019
- Primary completion15 Jun 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Inonu 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Ali Erdoğan, Inonu University
- Investigators
- Ulku Ozgul, MD, Principal investigator, Inonu University, Scholl of Madicine, Malatya Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232904
- Sponsor's protocol ID
- MAE7
- Status last verified
- Jan 2020
- First submitted
- 17 Dec 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bagry H, de la Cuadra Fontaine JC, Asenjo JF, Bracco D, Carli F. Effect of a continuous peripheral nerve block on the inflammatory response in knee arthroplasty. Reg Anesth Pain Med. 2008 Jan-Feb;33(1):17-23. doi: 10.1016/j.rapm.2007.06.398.
PubMed 18155052Kitlik A, Erdogan MA, Ozgul U, Aydogan MS, Ucar M, Toprak HI, Colak C, Durmus M. Ultrasound-guided transversus abdominis plane block for postoperative analgesia in living liver donors: A prospective, randomized, double-blinded clinical trial. J Clin Anesth. 2017 Feb;37:103-107. doi: 10.1016/j.jclinane.2016.12.018. Epub 2017 Jan 7.
PubMed 28235493
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transversus Abdominis Plane Block With Bupivacaine on Anti-inflammatory Response in Living Liver Donors
- ClinicalTrials.gov ID
- NCT04232904
- Acronym / sponsor ID
- MAE7
- Keywords
- living liver donor, TAP block, cytokine, bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 15 Jun 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 18 Jan 2020 (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.
The liver transplantation is the only treatment for end-stage liver failure. Lack of sufficient organs from the cadaver to meet the organ needs has increased the interest in a live organ donor transplantation. A peripheral nerve block, transversus abdominous plane block (TAP block); When combined with general anesthesia in live liver donors, it has been shown to significantly reduce perioperative and postoperative opioid consumption, provide shorter recovery time and shorten hospital stay. It has been shown that regional block techniques using local anesthetics and analgesic adjuvants modulate both local and systemic inflammatory reactions caused by surgical injury. Cytokines are important mediators of local and systemic inflammatory response including hyperalgesia after surgery. In literature, the effect of TAP block on anti-inflammatory cytokines in live liver donors was not shown. The aim of this study is to investigate the effect of bupivacaine TAP block on antiflammatory response in living liver donors.
Detailed description
The liver transplantation is the only treatment for end-stage liver failure. Lack of sufficient organs from the cadaver to meet the organ needs has increased the interest in a live organ donor transplantation. A peripheral nerve block, transversus abdominous plane block (TAP block); When combined with general anesthesia in live liver donors, it has been shown to significantly reduce perioperative and postoperative opioid consumption, provide shorter recovery time and shorten hospital stay.Immunological, metabolic and endocrine reactions occur due to tissue damage, pain and anesthesia caused by surgery. It has been shown that regional block techniques using local anesthetics and analgesic adjuvants modulate both local and systemic inflammatory reactions caused by surgical injury. Cytokines are important mediators of local and systemic inflammatory response including hyperalgesia after surgery. Cytokines are indispensable for wound healing and restoration of homeostasis, but usually the overactivity of either proinflammatory or anti-inflammatory cytokines damages the host. With Preemptive epidural analgesia, peripheral nerve block and thoracic epidural analgesia; postoperative pain and proinflammatory cytokines have been reduced. In literature, the effect of TAP block on anti-inflammatory cytokines in live liver donors was not shown. The aim of this study is to investigate the effect of bupivakine TAP block on antiinflammatory response in live liver donors.This prospective clinical study will performs in 72 liver transplant donors aged 18-65 years, ASA I-II, schedule for right hepatectomy surgery. Peripheral vascular access will open and blood samples will take for preoperative cytokine and bupivacaine measurements.The primary aim of this study was to investigate the effect of TAP block on the inflammatory response by cytokine level. The secondary aim of this study is to determine the plasma bupivacaine concentrations in patients undergoing TAP block and to investigate the relationship between plasma bupivacaine level and cytokine levels.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP Block Group | Active comparator | Procedure: Transversus abdominous plane block (TAP Block)this is study group. |
| Control Group | No intervention | –This patients are control group. TAP block will be not perform |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- liver transplant donors schedule for right hepatectomy surgery.
- aged 18-65 years,
Key exclusion criteria (5 listed)
- systemic disease (such as diabetes and hypertension),
- used opioid or NSAID in the last week,
- coagulation pathology,
- a history of allergy to drugs used in the study
- refusal to participate in the study.
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 |
|---|---|---|
| Transversus abdominous plane block (TAP Block)TAP block which is a peripheral nerve block preferred to postoperative pain management. | Procedure or surgery | TAP Block Group |
Primary outcome
cytokine level (interleukine-1, interleukine-6, tumor necrosis factor)
Time frame: Change from baseline cytokines levels at 24 hours postoperatively
Immunological, metabolic and endocrine reactions occur due to tissue damage, pain and anesthesia caused by surgery. Cytokines are important mediators of local and systemic inflammatory response including hyperalgesia after surgery. Cytokines are indispensable for wound healing and restoration of homeostasis, but usually the overactivity of either proinflammatory or anti-inflammatory cytokines damages the host.
2 secondary outcomes
correlation of plasma bupivacaine level and cytokine level
Time frame: Change from baseline correlation of plasma bupivacaine level and cytokines levels at 24 hours postoperatively
The plasma bupivacaine concentrations
Time frame: Change from baseline plasma bupivacaine concentrations at 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Background: PubMed 18155052Bagry H, de la Cuadra Fontaine JC, Asenjo JF, Bracco D, Carli F. Effect of a continuous peripheral nerve block on the inflammatory response in knee arthroplasty. Reg Anesth Pain Med. 2008 Jan-Feb;33(1):17-23. doi: 10.1016/j.rapm.2007.06.398.
- Results publication: PubMed 28235493Kitlik A, Erdogan MA, Ozgul U, Aydogan MS, Ucar M, Toprak HI, Colak C, Durmus M. Ultrasound-guided transversus abdominis plane block for postoperative analgesia in living liver donors: A prospective, randomized, double-blinded clinical trial. J Clin Anesth. 2017 Feb;37:103-107. doi: 10.1016/j.jclinane.2016.12.018. Epub 2017 Jan 7.
- 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.
Ulku Ozgul, MD principal investigator
Inonu University, Scholl of Madicine, Malatya Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transversus abdominous plane block (TAP Block) in people with Liver Transplant; Complications and Inflammatory Response, run by Inonu 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Jan 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet A Erdogan, Prof. (+904223410660 ext. 6224, drmalierdogan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cytokine level (interleukine-1, interleukine-6, tumor necrosis factor) (time frame: Change from baseline cytokines levels at 24 hours postoperatively). 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 NCT04232904, which also lists 2 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 18 Jan 2020.