Effect of Transversus Abdominis Plane Block on Anti-inflammatory Response

Inflammatory Response Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04232904
• Other study ID #: MAE7
• Status: Recruiting
• Phase: Phase 4
• Start date: December 2, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: January 2020
• Source: Inonu University
• Contact: Mehmet A Erdogan, Prof.
• Phone: +904223410660
• Email: drmalierdogan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 1, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Response
• Liver Transplant; Complications

Intervention

Procedure:
• Transversus abdominous plane block (TAP Block)
TAP block which is a peripheral nerve block preferred to postoperative pain management.

Locations

Country	Name	City	State
Turkey	Inonu university	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

Kitlik 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 Anest — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline cytokines levels at 24 hours postoperatively
Secondary	correlation of plasma bupivacaine level and cytokine level	The relationship between plasma bupivacaine level and cytokine level in patients undergoing TAP block	Change from baseline correlation of plasma bupivacaine level and cytokines levels at 24 hours postoperatively
Secondary	The plasma bupivacaine concentrations	The plasma bupivacaine concentrations in patients undergoing TAP block	Change from baseline plasma bupivacaine concentrations at 24 hours postoperatively