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

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2017-12-31

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.

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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

Conditions

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Colon Neoplasm Rectum Neoplasm Perforated Colon Perforated Bowel

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Double Blind study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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TAP group

Drug: 0.25% Bupivacaine, 0.5mL/kg

Group Type EXPERIMENTAL

0.25% Bupivacaine, 0.5mL/kg

Intervention Type DRUG

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

Ultrasound

Intervention Type DEVICE

Ultrasound guided TAP block

Placebo group

Drug: 0.9% Normal Saline, 0.5mL/kg

Group Type SHAM_COMPARATOR

Normal Saline

Intervention Type DRUG

0.9% Normal Saline

Ultrasound

Intervention Type DEVICE

Ultrasound guided TAP block

Interventions

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0.25% Bupivacaine, 0.5mL/kg

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

Intervention Type DRUG

Normal Saline

0.9% Normal Saline

Intervention Type DRUG

Ultrasound

Ultrasound guided TAP block

Intervention Type DEVICE

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No