Ultrasound Guided Transversus Abdominis Plane(TAP) Block... | NCT03198338

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

NCT03198338

Sponsor

Seoul National University Bundang Hospital

Status

Unknown status

Last Update Posted

Jun 26, 2017Actual

Enrollment

46Estimated

Phase

Not Applicable

Conditions

Colon Neoplasm
Rectum Neoplasm
Perforated Colon
Perforated Bowel

Interventions

0.25% Bupivacaine, 0.5mL/kg
Normal Saline
Ultrasound

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2017Estimated

Primary Completion Date

Dec 31, 2017Estimated

Completion Date

Dec 31, 2017Estimated

First Submitted Date

Jun 20, 2017

First Submission Date that Met QC Criteria

Jun 23, 2017

First Posted Date

Jun 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2017

Last Update Posted Date

Jun 26, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tak Kyu Oh, Clinical Professor of Anesthesiology and Pain department, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
0.25% Bupivacaine, 0.5mL/kg	Drug	Ultrasound guided TAP block using 0.25% Bupivacaine, 0.5ml/kg	TAP group

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tak Kyu Oh, M.D.	Contact	82-10-2602-5950		airohtak@hotmail.com
In Ae Song, M.D. Ph.D.	Contact			songoficu@outlook.kr

Overall Officials

Name	Affiliation	Role
In Ae Song, M.D. Ph.D.	Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Pain department	Recruiting	Seongnam-si	Gyeong Gi Do	13620	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19681428	Background	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.

ID	Term
D003110	Colonic Neoplasms
D012004	Rectal Neoplasms
D007416	Intestinal Perforation

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

ID	Term
D002045	Bupivacaine
D000077330	Saline Solution
D014463	Ultrasonography

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds