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

Seoul National University

Status: Unknown

Conditions: Perforated Colon; Colon Neoplasm; Perforated Bowel; Rectum Neoplasm

Treatments: Drug: 0.25% Bupivacaine, 0.5mL/kg; Drug: Normal Saline; Device: Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT03198338

B1706-401-001

Details and patient eligibility

About

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.

Full 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

Enrollment: 46 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups

TAP group

Experimental group

Description:

Drug: 0.25% Bupivacaine, 0.5mL/kg

Treatment:

Device: Ultrasound

Drug: 0.25% Bupivacaine, 0.5mL/kg

Placebo group

Sham Comparator group

Description:

Drug: 0.9% Normal Saline, 0.5mL/kg

Treatment:

Device: Ultrasound

Drug: Normal Saline