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

Not Applicable

• Conditions: Perforated Bowel; Rectum Neoplasm; Perforated Colon; Colon Neoplasm
• Interventions: Drug: 0.25% Bupivacaine, 0.5mL/kg; Drug: Normal Saline; Device: Ultrasound

• Registration Number: NCT03198338
• Lead Sponsor: Seoul National University Bundang Hospital

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.

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 Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-23
• Last Update Submitted: 2017-06-23
• Study First Posted: 2017-06-26
• Last Update Posted: 2017-06-26
• Study Start: 2017-07-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP group	0.25% Bupivacaine, 0.5mL/kg	Drug: 0.25% Bupivacaine, 0.5mL/kg
TAP group	Ultrasound	Drug: 0.25% Bupivacaine, 0.5mL/kg
Placebo group	Normal Saline	Drug: 0.9% Normal Saline, 0.5mL/kg
Placebo group	Ultrasound	Drug: 0.9% Normal Saline, 0.5mL/kg

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain department; 🇰🇷 Seongnam-si, Gyeong gi do, Korea, Republic of