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

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03198338

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Neoplasm Rectum Neoplasm Perforated Colon Perforated Bowel	Drug: 0.25% Bupivacaine, 0.5mL/kg Drug: Normal Saline Device: Ultrasound	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Double Blind studyRandomized Double Blind study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Drugs that are not directly involved in the study are delivered to the practitioner without specific labeling of the drug to be used in the block. The practitioner, the patient, and the observer all undergo TAP block without knowing which group the patient belongs to.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2017

Anticipated Primary Completion Date :

Dec 31, 2017

Anticipated Study Completion Date :

Dec 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAP group Drug: 0.25% Bupivacaine, 0.5mL/kg	Drug: 0.25% Bupivacaine, 0.5mL/kg Ultrasound guided TAP block using 0.25% Bupivacaine, 0.5ml/kg Device: Ultrasound Ultrasound guided TAP block
Sham Comparator: Placebo group Drug: 0.9% Normal Saline, 0.5mL/kg	Drug: Normal Saline 0.9% Normal Saline Device: Ultrasound Ultrasound guided TAP block

Arm

Intervention/Treatment

Experimental: TAP group

Drug: 0.25% Bupivacaine, 0.5mL/kg

Drug: 0.25% Bupivacaine, 0.5mL/kg

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

Device: Ultrasound

Ultrasound guided TAP block

Sham Comparator: Placebo group

Drug: 0.9% Normal Saline, 0.5mL/kg

Drug: Normal Saline

0.9% Normal Saline

Device: Ultrasound

Ultrasound guided TAP block

Outcome Measures

Primary Outcome Measures

opioid consumption up to 24 hours [24hour after TAP block]
The total amount of IV Fentanyl (10mcg/cc) used by the patients for 24 hours. Patient Controlled Analgesia will be used.

Secondary Outcome Measures

resting pain score [2hour, 6hour, 12hour, 24hour after TAP block]
resting Numeric Rating Scale, 0-10, 0= no pain, 10= most severe pain
Nausea score [2hour, 6hour, 12hour, 24hour after TAP block]
Nausea score, 0=none, 1=nausea symptom, 2- nausea requiring treatment, 3=vomiting
sedation score [2hour, 6hour, 12hour, 24hour after TAP block]
0- awake, 1- mild sedation, easy to rouse, 1s= asleep, easy to rouse, 2-moderate sedation, unable to remain awake, 3- difficult to rouse

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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