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 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.
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
Exclusion Criteria:
Drug: 0.25% Bupivacaine, 0.5mL/kg
Drug: 0.25% Bupivacaine, 0.5mL/kg · Device: Ultrasound
Drug: 0.9% Normal Saline, 0.5mL/kg
Drug: Normal Saline · Device: Ultrasound
Ultrasound guided TAP block using 0.25% Bupivacaine, 0.5ml/kg
0.9% Normal Saline
Ultrasound guided TAP block
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
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
Nausea score
Nausea score, 0=none, 1=nausea symptom, 2- nausea requiring treatment, 3=vomiting
Time frame: 2hour, 6hour, 12hour, 24hour after TAP block
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
Plan to share: Yes — It can be shared after request to principal investigator (T.K Oh or I.A Song)
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Seoul National University Bundang Hospital