Pain, PostoperativePhase 4NCT03805269
Transversus Abdominis Plane(TAP) Block Versus Local Anesthetic Infiltration
A Phase 4 study testing TAP block and wound infiltration in people with Pain, Postoperative, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
There have been some studies to compared trans abdominis plane(TAP) block with wound infiltration of local anesthetics in multiport laparoscopic surgery, but there have been no studies in single incision laparoscopic gastrectomy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- TAP block and wound infiltration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Mar 2019to 31 Dec 2024
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class I-II
- Age: >18
Who cannot join
- patients of severe kidney \& liver dysfunction
- allergy of local anesthetics
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National Universuty, Bundang Hospital
Seongnam-si, Gyonggido
Bon-Wook Koo, MD, +82-10-7227-1379, tendong2@gmail.com
About this study
Official title: Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane(TAP) Block Versus Local Anesthetic Infiltration in Adult Patients Undergoing Single Incision Laparoscopic Gastrectomy: A Randomized Controlled Trial
There have been some studies to compared trans abdominis plane(TAP) block with wound infiltration of local anesthetics in multiport laparoscopic surgery, but there have been no studies in single incision laparoscopic gastrectomy.
The purpose of this study was to compare the effect of ultrasonography-guided transverse nerve block and localized anesthesia infiltration in patients with single incision laparoscopic gastrectomy.
Read the detailed description
Patients were randomly divided into group N(ultrasonography-guided TAP) block and group W( before surgery local anesthetic infiltration at the incision site). We compared the opioid usage, postoperative 6, 24, and 48 hours pain, presence of vomiting, and duration of hospitalization during the operation.
- Conditions
- Pain, Postoperative
- Being tested
- TAP block, wound infiltration
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP blockDrug
Also called TAP
TAP block: local anesthetics infiltration at trans abdominis plane
wound infiltrationDrug
Also called Wound
wound infiltration: local anesthetics infiltration at surgical incision
| Study group | Role | What they receive |
|---|---|---|
| TAP block | Experimental | USG guided TAP block Receives: Drug: TAP block |
| wound infiltration | Active comparator | local anesthetics infiltration at surgical incision site Receives: Drug: wound infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain score
100 mm scale of visual analogue scale
Measured: 4 hours after end of surgery
Secondary outcomes (1)
post operative opioid consumption
total amount of opioid
Measured: 4 hours after end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start14 Mar 2019
- Primary completion28 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BON WOOK KOO, Seoul National University Bundang Hospital
- Investigators
- Jung-hi Ryu, Dr., Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805269
- Sponsor's protocol ID
- SNUBHTAP
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2019
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane(TAP) Block Versus Local Anesthetic Infiltration in Adult Patients Undergoing Single Incision Laparoscopic Gastrectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03805269
- Acronym / sponsor ID
- SNUBHTAP
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 28 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Jan 2019 (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.
There have been some studies to compared trans abdominis plane(TAP) block with wound infiltration of local anesthetics in multiport laparoscopic surgery, but there have been no studies in single incision laparoscopic gastrectomy.
The purpose of this study was to compare the effect of ultrasonography-guided transverse nerve block and localized anesthesia infiltration in patients with single incision laparoscopic gastrectomy.
Detailed description
Patients were randomly divided into group N(ultrasonography-guided TAP) block and group W( before surgery local anesthetic infiltration at the incision site). We compared the opioid usage, postoperative 6, 24, and 48 hours pain, presence of vomiting, and duration of hospitalization during the operation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block | Experimental | Drug: TAP blockUSG guided TAP block |
| wound infiltration | Active comparator | Drug: wound infiltrationlocal anesthetics infiltration at surgical incision site |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA class I-II
- Age: >18
Key exclusion criteria (2 listed)
- patients of severe kidney \& liver dysfunction
- allergy of local anesthetics
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 |
|---|---|---|
| TAP blockAlso: TAPTAP block: local anesthetics infiltration at trans abdominis plane | Drug | TAP block |
| wound infiltrationAlso: Woundwound infiltration: local anesthetics infiltration at surgical incision | Drug | wound infiltration |
Primary outcome
post operative pain score
Time frame: 4 hours after end of surgery
100 mm scale of visual analogue scale
1 secondary outcome
post operative opioid consumption
Time frame: 4 hours after end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
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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.
Jung-hi Ryu, Dr. study chair
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 Phase 4 study testing TAP block and wound infiltration in people with Pain, Postoperative, 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 2 inclusion and 2 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 16 Jan 2024. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Bon-Wook Koo, Dr. (+82-10-7227-1379, tendong2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain score (time frame: 4 hours after end of surgery). 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 16 Jan 2024.