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
2,457 studies on the registry are indexed under Colonic Neoplasms; 458 are open to participants now.
This study's planned enrollment of 46 is below the median of 75 across 1,711 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Seoul National University Bundang Hospital is the lead sponsor of 376 studies on the registry; 56 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug page: Bupivacaine
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)
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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Studies of the drug tested here: Bupivacaine
Seoul National University Bundang Hospital →