Laparoscopic ColecctomyPhase 3NCT01423292
Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection
A Phase 3 study testing Ultrasound Guided Transversus Abdominis Plane (TAP) Block and bupivacaine in people with Laparoscopic Colecctomy, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether the transversus abdominis plane (TAP) blocks are effective in postoperative pain control of adult patients undergoing laparoscopic colectomy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Laparoscopic Colecctomy
- What is being tested?
- Ultrasound Guided Transversus Abdominis Plane (TAP) Block and bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Apr 2012
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 20~80
- undergoing laparoscopic colectomy
Who cannot join
- allergic history to local anesthesitcs
- tolerance to opioid
- cannot use IV-PCA
- previous abdominal surgery
- intestinal obstruction
- emergency
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether the transversus abdominis plane (TAP) blocks are effective in postoperative pain control of adult patients undergoing laparoscopic colectomy.
- Conditions
- Laparoscopic Colecctomy
- Being tested
- Ultrasound Guided Transversus Abdominis Plane (TAP) Block, bupivacaine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Transversus Abdominis Plane (TAP) BlockProcedure or surgery
Ultrasound Guided Transversus Abdominis Plane (TAP) Block
bupivacaineDrug
0.25 bupivacaine 30ml (15ml on each side)
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| an odd numbered patients | Active comparator | TAP block with local anesthetics Receives: Procedure: Ultrasound Guided Transversus Abdominis Plane (TAP) Block; Drug: bupivacaine |
| an even numbered patients | Placebo comparator | TAP block without local anesthetics Receives: Procedure: Ultrasound Guided Transversus Abdominis Plane (TAP) Block; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score during cough
pain score during cough at 24 hours after TAP block (using visual analog scale)
Measured: 24hr after TAP block
Secondary outcomes (1)
pain score during bed rest and ambulation at ward, dosage of used opioid, nausea score, sedation score, days of hospitalization, start day of diet, reinsertion rate of urinary catheter, satisfaction measurement of pain control, life of quality
Measured: 24hr, 48hr, 72hr 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 posted25 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic ColecctomyStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ji Won Park, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423292
- Sponsor's protocol ID
- NCCCTS-11-557
- Status last verified
- Aug 2012
- First submitted
- 18 Aug 2011
- Last updated
- 6 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia After Laparoscopic Colonic Resection
- ClinicalTrials.gov ID
- NCT01423292
- Acronym / sponsor ID
- NCCCTS-11-557
- Conditions
- Laparoscopic Colecctomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Aug 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 25 Aug 2011 (estimated)
- 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 purpose of this study is to determine whether the transversus abdominis plane (TAP) blocks are effective in postoperative pain control of adult patients undergoing laparoscopic colectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| an odd numbered patients | Active comparator | Procedure: Ultrasound Guided Transversus Abdominis Plane (TAP) Block, Drug: bupivacaineTAP block with local anesthetics |
| an even numbered patients | Placebo comparator | Procedure: Ultrasound Guided Transversus Abdominis Plane (TAP) Block, Drug: PlaceboTAP block without local anesthetics |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 20~80
- undergoing laparoscopic colectomy
Key exclusion criteria (6 listed)
- allergic history to local anesthesitcs
- tolerance to opioid
- cannot use IV-PCA
- previous abdominal surgery
- intestinal obstruction
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 |
|---|---|---|
| Ultrasound Guided Transversus Abdominis Plane (TAP) BlockUltrasound Guided Transversus Abdominis Plane (TAP) Block | Procedure or surgery | an even numbered patients, an odd numbered patients |
| bupivacaine0.25 bupivacaine 30ml (15ml on each side) | Drug | an odd numbered patients |
| Placeboplacebo | Drug | an even numbered patients |
Primary outcome
pain score during cough
Time frame: 24hr after TAP block
pain score during cough at 24 hours after TAP block (using visual analog scale)
1 secondary outcome
pain score during bed rest and ambulation at ward, dosage of used opioid, nausea score, sedation score, days of hospitalization, start day of diet, reinsertion rate of urinary catheter, satisfaction measurement of pain control, life of quality
Time frame: 24hr, 48hr, 72hr after TAP block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2012.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ultrasound Guided Transversus Abdominis Plane (TAP) Block and bupivacaine in people with Laparoscopic Colecctomy, run by National Cancer Center, Korea 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 6 Aug 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score during cough (time frame: 24hr after TAP block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2012.