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
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- opioid consumption up to 24 hours
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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.
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- 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
- •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
Arms & Interventions
TAP group
Drug: 0.25% Bupivacaine, 0.5mL/kg
Intervention: 0.25% Bupivacaine, 0.5mL/kg (Drug)
TAP group
Drug: 0.25% Bupivacaine, 0.5mL/kg
Intervention: Ultrasound (Device)
Placebo group
Drug: 0.9% Normal Saline, 0.5mL/kg
Intervention: Normal Saline (Drug)
Placebo group
Drug: 0.9% Normal Saline, 0.5mL/kg
Intervention: Ultrasound (Device)
Outcomes
Primary Outcomes
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 Outcomes
- resting pain score(2hour, 6hour, 12hour, 24hour after TAP block)
- Nausea score(2hour, 6hour, 12hour, 24hour after TAP block)
- sedation score(2hour, 6hour, 12hour, 24hour after TAP block)
Investigators
Tak Kyu Oh
Clinical Professor of Anesthesiology and Pain department
Seoul National University Bundang Hospital