NCT04232904

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

December 17, 2019

Last Update Submit

January 16, 2020

Conditions

Liver Transplant; ComplicationsInflammatory Response

Keywords

living liver donorTAP blockcytokinebupivacaine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • correlation of plasma bupivacaine level and cytokine level

    Change from baseline correlation of plasma bupivacaine level and cytokines levels at 24 hours postoperatively

  • The plasma bupivacaine concentrations

    Change from baseline plasma bupivacaine concentrations at 24 hours postoperatively

Study Arms (2)

TAP Block Group

ACTIVE COMPARATOR

this is study group.

Procedure: Transversus abdominous plane block (TAP Block)

Control Group

NO INTERVENTION

This patients are control group. TAP block will be not perform

Interventions

Transversus abdominous plane block (TAP Block)PROCEDURE

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

TAP Block Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsParticipant eligibility is not based on self-representation of gender identity.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu university

Malatya, 044100, Turkey (Türkiye)

RECRUITING

Related 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. doi: 10.1016/j.rapm.2007.06.398.

    PMID: 18155052BACKGROUND

  • 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 Anesth. 2017 Feb;37:103-107. doi: 10.1016/j.jclinane.2016.12.018. Epub 2017 Jan 7.

    PMID: 28235493RESULT

Study Officials

  • Ulku Ozgul, MD

    Inonu University, Scholl of Madicine, Malatya Turkey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet A Erdogan, Prof.

CONTACT

+904223410660drmalierdogan@gmail.com

Muharrem Ucar, MD

CONTACT

+904223410660umuharrem@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 17, 2019

First Posted

January 18, 2020

Study Start

December 2, 2019

Primary Completion

June 15, 2020

Study Completion

July 1, 2020

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)