Clinical trial NCT03198338: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Neoplasm
Rectum Neoplasm
Perforated Colon
Perforated Bowel
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 46
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Double Blind study
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: opioid consumption up to 24 hours
timeFrame: 24hour after TAP block
Secondary outcomes:
measure: resting pain score
timeFrame: 2hour, 6hour, 12hour, 24hour after TAP block
measure: Nausea score
timeFrame: 2hour, 6hour, 12hour, 24hour after TAP block
measure: sedation score
timeFrame: 2hour, 6hour, 12hour, 24hour after TAP block
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Department of Anesthesiology and Pain department
state: Gyeong gi do
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital
name: In Ae Song, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.