Effect of Transversus Abdominis Plane Block on Anti-inflammatory Response

NCT ID: NCT04232904

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-02

Study Completion Date

2020-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Transplant; Complications Inflammatory Response

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TAP Block Group

this is study group.

Group Type ACTIVE_COMPARATOR

Transversus abdominous plane block (TAP Block)

Intervention Type PROCEDURE

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

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transversus abdominous plane block (TAP Block)

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Inonu University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mehmet Ali Erdoğan

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ulku Ozgul, MD

Role: PRINCIPAL_INVESTIGATOR

Inonu University, Scholl of Madicine, Malatya Turkey

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Inonu university

Malatya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mehmet A Erdogan, Prof.

Role: CONTACT

+904223410660 ext. 6224

Muharrem Ucar, MD

Role: CONTACT

+904223410660 ext. 3163

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mehmet A Erdogan, MD

Role: primary

+904223410660

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 18155052 (View on PubMed)

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.

Reference Type RESULT
PMID: 28235493 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MAE7

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.