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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Ultrasound Guided Transversus Abdominis Plane(TAP) Block in Intensive Care Unit(ICU) for Postoperative Analgesia After Open Colon Resection: a Double Blind Randomized Controlled Trial

Conditions
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Colon Neoplasm, Rectum Neoplasm, Perforated Colon, Perforated Bowel

Intervention / Treatment
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* Drug: 0.25% Bupivacaine, 0.5mL/kg
* Drug: Normal Saline
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Double Blind study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP group<br>Drug: 0.25% Bupivacaine, 0.5mL/kg | Drug: 0.25% Bupivacaine, 0.5mL/kg<br>* Ultrasound guided TAP block using 0.25% Bupivacaine, 0.5ml/kg<br>Device: Ultrasound<br>* Ultrasound guided TAP block<br>|
| Sham Comparator: Placebo group<br>Drug: 0.9% Normal Saline, 0.5mL/kg | Drug: Normal Saline<br>* 0.9% Normal Saline<br>Device: Ultrasound<br>* Ultrasound guided TAP block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24hour after TAP block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resting pain score | resting Numeric Rating Scale, 0-10, 0= no pain, 10= most severe pain | 2hour, 6hour, 12hour, 24hour after TAP block | 
| Nausea score | Nausea score, 0=none, 1=nausea symptom, 2- nausea requiring treatment, 3=vomiting | 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 | 2hour, 6hour, 12hour, 24hour after TAP block |