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

Primary Purpose

Colon Neoplasm, Rectum Neoplasm, Perforated Colon

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

0.25% Bupivacaine, 0.5mL/kg

Normal Saline

Ultrasound

About this trial

This is an interventional treatment trial for Colon Neoplasm

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Department of Anesthesiology and Pain departmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

TAP group

Placebo group

Arm Description

Drug: 0.25% Bupivacaine, 0.5mL/kg

Drug: 0.9% Normal Saline, 0.5mL/kg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

resting pain score

resting Numeric Rating Scale, 0-10, 0= no pain, 10= most severe pain

Nausea score

Nausea score, 0=none, 1=nausea symptom, 2- nausea requiring treatment, 3=vomiting

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

Full Information

NCT ID

NCT03198338

First Posted

June 20, 2017

Last Updated

June 23, 2017

Sponsor

Seoul National University Bundang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03198338

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2017 (Anticipated)

Primary Completion Date

December 31, 2017 (Anticipated)

Study Completion Date

December 31, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Neoplasm, Rectum Neoplasm, Perforated Colon, Perforated Bowel

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized Double Blind study

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TAP group

Arm Type

Experimental

Arm Description

Drug: 0.25% Bupivacaine, 0.5mL/kg

Arm Title

Placebo group

Arm Type

Sham Comparator

Arm Description

Drug: 0.9% Normal Saline, 0.5mL/kg

Intervention Type

Drug

Intervention Name(s)

0.25% Bupivacaine, 0.5mL/kg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Normal Saline

Intervention Description

0.9% Normal Saline

Intervention Type

Device

Intervention Name(s)

Ultrasound

Intervention Description

Ultrasound guided TAP block

Primary Outcome Measure Information:

Title

opioid consumption up to 24 hours

Description

The total amount of IV Fentanyl (10mcg/cc) used by the patients for 24 hours. Patient Controlled Analgesia will be used.

Time Frame

24hour after TAP block

Secondary Outcome Measure Information:

Title

resting pain score

Description

resting Numeric Rating Scale, 0-10, 0= no pain, 10= most severe pain

Time Frame

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

Title

Nausea score

Description

Nausea score, 0=none, 1=nausea symptom, 2- nausea requiring treatment, 3=vomiting

Time Frame

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

Title

sedation score

Description

0- awake, 1- mild sedation, easy to rouse, 1s= asleep, easy to rouse, 2-moderate sedation, unable to remain awake, 3- difficult to rouse

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tak Kyu Oh, M.D.

Phone

82-10-2602-5950

airohtak@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

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

songoficu@outlook.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Anesthesiology and Pain department

City

Seongnam-si

State/Province

Gyeong gi do

ZIP/Postal Code

13620

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tak Kyu Oh, M.D.

Phone

82-10-2602-5950

airohtak@hotmail.com

First Name & Middle Initial & Last Name & Degree

In Ae Song, M.D Ph.D.

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

It can be shared after request to principal investigator (T.K Oh or I.A Song)

Citations:

PubMed Identifier

19681428

Citation

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.

Results Reference

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

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