Colon NeoplasmNCT03198338
Ultrasound Guided Transversus Abdominis Plane(TAP) Block in Intensive Care Unit
A study testing 0.25% Bupivacaine, 0.5mL/kg, Normal Saline and Ultrasound in people with Colon Neoplasm and Rectum Neoplasm, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colon Neoplasm, Rectum Neoplasm, Perforated Colon
- What is being tested?
- 0.25% Bupivacaine, 0.5mL/kg, Normal Saline and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2017to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
In Ae Song, M.D. Ph.D. contact
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain department
Seongnam-si, Gyeong Gi Do, 13620
Tak Kyu Oh, M.D., 82-10-2602-5950, airohtak@hotmail.com
In Ae Song, M.D Ph.D.
About this study
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
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
- Conditions
- Colon Neoplasm, Rectum Neoplasm, Perforated Colon, Perforated Bowel
- Being tested
- 0.25% Bupivacaine, 0.5mL/kg, Normal Saline, Ultrasound
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Intestinal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25% Bupivacaine, 0.5mL/kgDrug
Ultrasound guided TAP block using 0.25% Bupivacaine, 0.5ml/kg
Normal SalineDrug
0.9% Normal Saline
UltrasoundDevice
Ultrasound guided TAP block
| Study group | Role | What they receive |
|---|---|---|
| TAP group | Experimental | Drug: 0.25% Bupivacaine, 0.5mL/kg Receives: Drug: 0.25% Bupivacaine, 0.5mL/kg; Device: Ultrasound |
| Placebo group | Sham comparator | Drug: 0.9% Normal Saline, 0.5mL/kg Receives: Drug: Normal Saline; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24hour after TAP block
Secondary outcomes (3)
resting pain score
resting Numeric Rating Scale, 0-10, 0= no pain, 10= most severe pain
Measured: 2hour, 6hour, 12hour, 24hour after TAP block
Nausea score
Nausea score, 0=none, 1=nausea symptom, 2- nausea requiring treatment, 3=vomiting
Measured: 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
Measured: 2hour, 6hour, 12hour, 24hour after TAP block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start1 Jul 2017 (estimated)
- Primary completion31 Dec 2017 (estimated)
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon NeoplasmStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Double Blind study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tak Kyu Oh, Seoul National University Bundang Hospital
- Investigators
- In Ae Song, M.D. Ph.D., Principal investigator, Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198338
- Sponsor's protocol ID
- B1706-401-001
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2017
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It can be shared after request to principal investigator (T.K Oh or I.A Song)
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03198338
- Acronym / sponsor ID
- B1706-401-001
- Conditions
- Colon Neoplasm, Rectum Neoplasm, Perforated Colon, Perforated Bowel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 26 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Double Blind study
| Arm | Type | Receives |
|---|---|---|
| TAP group | Experimental | Drug: 0.25% Bupivacaine, 0.5mL/kg, Device: UltrasoundDrug: 0.25% Bupivacaine, 0.5mL/kg |
| Placebo group | Sham comparator | Drug: Normal Saline, Device: UltrasoundDrug: 0.9% Normal Saline, 0.5mL/kg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.25% Bupivacaine, 0.5mL/kgUltrasound guided TAP block using 0.25% Bupivacaine, 0.5ml/kg | Drug | TAP group |
| Normal Saline0.9% Normal Saline | Drug | Placebo group |
| UltrasoundUltrasound guided TAP block | Device | Placebo group, TAP group |
Primary outcome
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.
3 secondary outcomes
resting pain score
Time frame: 2hour, 6hour, 12hour, 24hour after TAP block
Nausea score
Time frame: 2hour, 6hour, 12hour, 24hour after TAP block
sedation score
Time frame: 2hour, 6hour, 12hour, 24hour after TAP block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Background: PubMed 19681428Niraj 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.
- Individual participant dataSharing planned: Yes. It can be shared after request to principal investigator (T.K Oh or I.A Song)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In Ae Song, M.D. Ph.D. contact
In Ae Song, M.D. Ph.D. principal investigator
Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.25% Bupivacaine, 0.5mL/kg, Normal Saline and Ultrasound in people with Colon Neoplasm and Rectum Neoplasm, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tak Kyu Oh, M.D. (82-10-2602-5950, airohtak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioid consumption up to 24 hours (time frame: 24hour after TAP block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03198338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.