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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tak Kyu Oh, M.D.; Phone Number: 82-10-2602-5950; Email: airohtak@hotmail.com
• Study Contact Backup: Name: In Ae Song, M.D. Ph.D.; Email: songoficu@outlook.kr

Study Locations

• Korea, Republic of
  • Gyeong gi do
    • Seongnam-si, Gyeong gi do, Korea, Republic of, 13620
      • Recruiting
      • Department of Anesthesiology and Pain department
      • Contact: Tak Kyu Oh, M.D.; Phone Number: 82-10-2602-5950; Email: airohtak@hotmail.com
      • Principal Investigator: In Ae Song, M.D Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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	Device: Ultrasound; Ultrasound guided TAP block; Drug: Normal Saline; 0.9% Normal Saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: In Ae Song, M.D. Ph.D., Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• Niraj G, Kelkar A, Fox AJ. Application of the transversus abdominis plane block in the intensive care unit. Anaesth Intensive Care. 2009 Jul;37(4):650-2. doi: 10.1177/0310057X0903700420.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): December 31, 2017

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 23, 2017
• First Posted (Actual): June 26, 2017

Study Record Updates

• Last Update Posted (Actual): June 26, 2017
• Last Update Submitted That Met QC Criteria: June 23, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Intestinal Perforation; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: B1706-401-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It can be shared after request to principal investigator (T.K Oh or I.A Song)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No