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

NCT03198338 | Unknown DMC

• 1 other identifier: B1706-401-001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Neoplasm; Rectum Neoplasm; Perforated Colon; Perforated Bowel

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• resting pain score

  2hour, 6hour, 12hour, 24hour after TAP block

• Nausea score

  2hour, 6hour, 12hour, 24hour after TAP block

• sedation score

  2hour, 6hour, 12hour, 24hour after TAP block

Study Arms (2)

TAP group

EXPERIMENTAL

Drug: 0.25% Bupivacaine, 0.5mL/kg

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

Placebo group

SHAM COMPARATOR

Drug: 0.9% Normal Saline, 0.5mL/kg

Drug: Normal Saline; Device: Ultrasound

Interventions

0.25% Bupivacaine, 0.5mL/kg DRUG

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

TAP group

Normal Saline DRUG

0.9% Normal Saline

Placebo group

Ultrasound DEVICE

Ultrasound guided TAP block

Placebo group; TAP group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Department of Anesthesiology and Pain department

Seongnam-si, Gyeong Gi Do, 13620, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 19681428 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Intestinal Perforation

Interventions

Bupivacaine; Saline Solution; Ultrasonography

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• In Ae Song, M.D. Ph.D.

  Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tak Kyu Oh, M.D.

CONTACT

82-10-2602-5950; airohtak@hotmail.com

In Ae Song, M.D. Ph.D.

CONTACT

songoficu@outlook.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Anesthesiology and Pain department

Model Details: Randomized Double Blind study

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 26, 2017
• Study Start: July 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: June 26, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)