CClinicalTrials.gg
Status unknownNCT03198338Updated Jun 26, 2017

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

An interventional study of 0.25% Bupivacaine, 0.5mL/kg and Normal Saline in Colon Neoplasm, Rectum Neoplasm and Perforated Colon, sponsored by Seoul National University Bundang Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-06-26.

Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Colon Neoplasm
  • Rectum Neoplasm
  • Perforated Colon
  • Perforated Bowel
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    TAP group

    Drug: 0.25% Bupivacaine, 0.5mL/kg

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

  • Sham comparator
    Placebo group

    Drug: 0.9% Normal Saline, 0.5mL/kg

    Drug: Normal Saline · Device: Ultrasound

Interventions

  • Drug0.25% Bupivacaine, 0.5mL/kg

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

  • DrugNormal Saline

    0.9% Normal Saline

  • DeviceUltrasound

    Ultrasound guided TAP block

05

What researchers measure

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.

    Time frame: 24hour after TAP block

Secondary outcomes

  1. resting pain score

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

    Time frame: 2hour, 6hour, 12hour, 24hour after TAP block

  2. Nausea score

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

    Time frame: 2hour, 6hour, 12hour, 24hour after TAP block

  3. 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

    Time frame: 2hour, 6hour, 12hour, 24hour after TAP block

06

Study locations

1 of 1 sites recruiting
  • Department of Anesthesiology and Pain department
    Seongnam-si, Gyeong gi do 13620, Korea, Republic of
    • Tak Kyu Oh, M.D. · Contact · airohtak@hotmail.com · 82-10-2602-5950
    • In Ae Song, M.D Ph.D. · Principal investigator
    Recruiting
07

References and documents

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. PubMed 19681428 ↗

Individual participant data

Plan to share: Yes — It can be shared after request to principal investigator (T.K Oh or I.A Song)

08

Registry details

Key details

Study ID
NCT03198338
Lead sponsor
Seoul National University Bundang Hospital
Responsible party
Tak Kyu Oh (Clinical Professor of Anesthesiology and Pain department, Seoul National University Bundang Hospital) — Principal investigator
First posted
Jun 26, 2017
Start date
Jul 1, 2017 (estimated)
Primary completion
Dec 31, 2017 (estimated)
Completion
Dec 31, 2017 (estimated)
Last update
Jun 26, 2017

Study contacts

Tak Kyu Oh, M.D.
Contact
airohtak@hotmail.com
82-10-2602-5950
In Ae Song, M.D. Ph.D.
Contact
songoficu@outlook.kr
In Ae Song, M.D. Ph.D.
principal investigator · Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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