Effect of Transversus Abdominis Plane Block on Anti-inflammatory Response

Phase 4

• Conditions: Inflammatory Response; Liver Transplant; Complications
• Interventions: Procedure: Transversus abdominous plane block (TAP Block)

• Registration Number: NCT04232904
• Lead Sponsor: Inonu University

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.

Study Timeline

• Study Start: 2019-12-02
• Study First Submitted: 2019-12-17
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-16
• Last Update Submitted: 2020-01-16
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-18
• Primary Completion: 2020-06-15
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP Block Group	Transversus abdominous plane block (TAP Block)	this is study group.

Primary Outcome Measures

Name	Time	Method
cytokine level (interleukine-1, interleukine-6, tumor necrosis factor)	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.

Secondary Outcome Measures

Name	Time	Method
correlation of plasma bupivacaine level and cytokine level	Change from baseline correlation of plasma bupivacaine level and cytokines levels at 24 hours postoperatively	The relationship between plasma bupivacaine level and cytokine level in patients undergoing TAP block
The plasma bupivacaine concentrations	Change from baseline plasma bupivacaine concentrations at 24 hours postoperatively	The plasma bupivacaine concentrations in patients undergoing TAP block

Trial Locations

Locations (1)

Inonu university; 🇹🇷 Malatya, Turkey