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Effect of Transversus Abdominis Plane Block on Anti-inflammatory Response

Effect of Transversus Abdominis Plane Block With Bupivacaine on Anti-inflammatory Response in Living Liver Donors

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04232904
Enrollment
70
Registered
2020-01-18
Start date
2019-12-02
Completion date
2020-07-01
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Response, Liver Transplant; Complications

Keywords

living liver donor, TAP block, cytokine, bupivacaine

Brief 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. 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.

Interventions

PROCEDURETransversus abdominous plane block (TAP Block)

TAP block which is a peripheral nerve block preferred to postoperative pain management.

Sponsors

Inonu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* liver transplant donors schedule for right hepatectomy surgery. * aged 18-65 years,

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
cytokine level (interleukine-1, interleukine-6, tumor necrosis factor)Change from baseline cytokines levels at 24 hours postoperativelyImmunological, 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.

Secondary

MeasureTime frameDescription
correlation of plasma bupivacaine level and cytokine levelChange from baseline correlation of plasma bupivacaine level and cytokines levels at 24 hours postoperativelyThe relationship between plasma bupivacaine level and cytokine level in patients undergoing TAP block
The plasma bupivacaine concentrationsChange from baseline plasma bupivacaine concentrations at 24 hours postoperativelyThe plasma bupivacaine concentrations in patients undergoing TAP block

Countries

Turkey (Türkiye)

Contacts

Primary ContactMehmet A Erdogan, Prof.
drmalierdogan@gmail.com+904223410660
Backup ContactMuharrem Ucar, MD
umuharrem@hotmail.com+904223410660

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026