Ultrasound Guided Transversus Abdominis Plane(TAP) Block in Intensive Care Unit

N/AUnknownNCT03198338

Seoul National University Bundang Hospital46 enrolled

Overview

The Transversus Abdominis Block (TAP) block is known to be an effective means of reducing patient pain after abdominal surgery. In the meantime, the general TAP block has been studied in patients who were in the recovery room and the ward after surgery. The purpose of this study was to determine the effect of pain reduction and opioid saving effects in patients with TAP block in ICU settings.

This study is a prospective study in a single institute of Seoul National University Bundang Hospital and is assigned to the test group and the control group by random assignment. In both groups, PCA (Patient Controlled Analgesia) was used as a post-operative pain control modality. In the Intervention group, a 0.25% Bupivacaine was used for transverse nerve block , and normal saline was used for placebo(control) group The TAP block will be performed within 1 hour after entering the intensive care unit (ICU) in double blinded state

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Colon Neoplasm Rectum Neoplasm Perforated Colon Perforated Bowel

Interventions

0.25% Bupivacaine, 0.5mL/kgDRUG

Ultrasound guided TAP block using 0.25% Bupivacaine, 0.5ml/kg

Normal SalineDRUG

0.9% Normal Saline

UltrasoundDEVICE

Ultrasound guided TAP block

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adults over 20 years of age * Patients who entered the intensive care unit for monitoring and recovery after colonic resection through laparotomy * Patients who voluntarily sign a written informed consent and know they have the right to withdraw their consent at any time. Exclusion Criteria: * Patients who are unconscious and require sedation below the Richmond Agitation Sedation Scale (-2) Patients who need continuous renal replacement therapy, cardiopulmonary bypass Patients with a history of allergic reactions to local anesthetics Patients resistant to narcotic analgesics (users of existing long-term narcotic analgesics) Patients who can not use self-analgesic treatment Patients who underwent surgery for organs other than abdomen and pelvis Patients with severe blood clotting disorders with a Prothrombin Time International normalized ratio of 2.0 or greater and Platelet less than 50,000

Locations (1)

Department of Anesthesiology and Pain department

Seongnam-si, Gyeong Gi Do, South Korea

RECRUITING

Outcomes

Primary Outcomes

opioid consumption up to 24 hours

The total amount of IV Fentanyl (10mcg/cc) used by the patients for 24 hours. Patient Controlled Analgesia will be used.

Time frame: 24hour after TAP block

Secondary Outcomes

resting pain score

resting Numeric Rating Scale, 0-10, 0= no pain, 10= most severe pain

Time frame: 2hour, 6hour, 12hour, 24hour after TAP block

Nausea score

Nausea score, 0=none, 1=nausea symptom, 2- nausea requiring treatment, 3=vomiting

Time frame: 2hour, 6hour, 12hour, 24hour after TAP block

sedation score

0- awake, 1- mild sedation, easy to rouse, 1s= asleep, easy to rouse, 2-moderate sedation, unable to remain awake, 3- difficult to rouse

Time frame: 2hour, 6hour, 12hour, 24hour after TAP block

Central Contacts

Tak Kyu Oh, M.D.

CONTACT

82-10-2602-5950 airohtak@hotmail.com

In Ae Song, M.D. Ph.D.

CONTACT

songoficu@outlook.kr

Data from ClinicalTrials.gov

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