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

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ClinicalTrials.gov Identifier: NCT03198338
Recruitment Status : Unknown
Verified June 2017 by Tak Kyu Oh, Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Tak Kyu Oh, 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.

Condition or disease Intervention/treatment Phase
Colon Neoplasm Rectum Neoplasm Perforated Colon Perforated Bowel Drug: 0.25% Bupivacaine, 0.5mL/kg Drug: Normal Saline Device: Ultrasound Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Double Blind study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
Drug Information available for: Bupivacaine

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
Drug: Normal Saline
0.9% Normal Saline

Device: Ultrasound
Ultrasound guided TAP block




Primary Outcome Measures :
  1. opioid consumption up to 24 hours [ Time Frame: 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 :
  1. resting pain score [ Time Frame: 2hour, 6hour, 12hour, 24hour after TAP block ]
    resting Numeric Rating Scale, 0-10, 0= no pain, 10= most severe pain

  2. Nausea score [ Time Frame: 2hour, 6hour, 12hour, 24hour after TAP block ]
    Nausea score, 0=none, 1=nausea symptom, 2- nausea requiring treatment, 3=vomiting

  3. sedation score [ Time Frame: 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



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198338


Contacts
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Contact: Tak Kyu Oh, M.D. 82-10-2602-5950 airohtak@hotmail.com
Contact: In Ae Song, M.D. Ph.D. songoficu@outlook.kr

Locations
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Korea, Republic of
Department of Anesthesiology and Pain department Recruiting
Seongnam-si, Gyeong gi do, Korea, Republic of, 13620
Contact: Tak Kyu Oh, M.D.    82-10-2602-5950    airohtak@hotmail.com   
Principal Investigator: In Ae Song, M.D Ph.D.         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: In Ae Song, M.D. Ph.D. Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital

Publications:
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Responsible Party: Tak Kyu Oh, Clinical Professor of Anesthesiology and Pain department, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03198338     History of Changes
Other Study ID Numbers: B1706-401-001
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: It can be shared after request to principal investigator (T.K Oh or I.A Song)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Rectal Neoplasms
Intestinal Perforation
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents