ChildTAPNCT01548027
Surgical Transversus Abdominis Plane Block in Pediatric Patients
A study testing Local infiltration group and TAP block in people with Child, run by Mahidol University at 1 site in Thailand.
Trial summary
The objective of this study to determine the effect of surgical transversus abdominis plane block and local infiltration for postoperative pain control in major abdominal surgery compare with control group. Read more about this study
- Who is it for?
- Ages Up to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Child
- What is being tested?
- Local infiltration group and TAP block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2012to Jul 2014
- 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 Up to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age < 15 year
- ASA I-III
- Abdominal surgery : all upper abdomen and lower abdomen which would have midline incision
- Elective surgery
Who cannot join
- Allergic to Lidocaine or bupivacaine
- Delayed development
- Major abdominal surgery within 2 year
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
About this study
Official title: Efficacy of Surgical Transversus Abdominis Plane Block for Postoperative Pain Relief Following Abdominal Surgery in Pediatric Patients.
The objective of this study to determine the effect of surgical transversus abdominis plane block and local infiltration for postoperative pain control in major abdominal surgery compare with control group.
Read the detailed description
Most children experience postoperative pain after major abdominal surgery. They may have ineffective ventilation, following atelectasis and pneumonia if receive inadequate pain management. There are several methods used for pain relief such as epidural block, intravenous analgesia with local infiltration, transversus abdominis plane (TAP) block by ultrasound guided and surgical TAP block. Therefore, the investigators would like to compare the effectiveness of postoperative pain control with TAP block. However, TAP block in children need experience and ultrasound. The investigators decided to do surgical TAP block performing by inject from peritoneum point to skin instead.
- Conditions
- Child
- Being tested
- Local infiltration group, TAP block, No intervention
- Keywords
- TAP block, postoperative analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local infiltration groupProcedure or surgery
Also called local anesthetic infiltration
patients would have 0.5 ml/kg of 0.25% bupivacaine if age < 6 months or 1 ml/kg if age > 6 months around the wound by surgeon. The needle will be injected in subcutaneous tissue parallel to the wound.
TAP blockProcedure or surgery
Also called surgical transversus abdominis plane block
Surgical TAP block (sTAP: Patients would have 0.5 ml/kg of 0.25% bupivacaine if age < 6 months or 1 ml/kg if age > 6 months
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| No intervention | Experimental | no injection of local anesthetic agents Receives: Other: No intervention |
| Local infiltration group | Experimental | patients would have 0.5 ml/kg of 0.25% bupivacaine if age < 6 months or 1 ml/kg if age > 6 months around the wound by surgeon. The needle will be injected in subcutaneous tissue parallel to the wound. Receives: Procedure: Local infiltration group |
| TAP block group | Experimental | Surgical TAP block (sTAP: Patients would have 0.5 ml/kg of 0.25% bupivacaine if age < 6 months or 1 ml/kg if age > 6 months Receives: Procedure: TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioids consumption
total opioids consumption in first 24 hours postoperatively
Measured: 24 hours
Secondary outcomes (1)
Time to first analgesic
Measured: 24 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saowaphak Lapmahapaisan, M.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548027
- Sponsor's protocol ID
- 752/2554
- Acronym
- TAP
- Status last verified
- Jul 2014
- First submitted
- 5 Mar 2012
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Surgical Transversus Abdominis Plane Block for Postoperative Pain Relief Following Abdominal Surgery in Pediatric Patients.
- ClinicalTrials.gov ID
- NCT01548027
- Acronym / sponsor ID
- TAP / 752/2554
- Conditions
- Child
- Keywords
- TAP block, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 8 Mar 2012 (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 objective of this study to determine the effect of surgical transversus abdominis plane block and local infiltration for postoperative pain control in major abdominal surgery compare with control group.
Detailed description
Most children experience postoperative pain after major abdominal surgery. They may have ineffective ventilation, following atelectasis and pneumonia if receive inadequate pain management. There are several methods used for pain relief such as epidural block, intravenous analgesia with local infiltration, transversus abdominis plane (TAP) block by ultrasound guided and surgical TAP block. Therefore, the investigators would like to compare the effectiveness of postoperative pain control with TAP block. However, TAP block in children need experience and ultrasound. The investigators decided to do surgical TAP block performing by inject from peritoneum point to skin instead.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No intervention | Experimental | Other: No interventionno injection of local anesthetic agents |
| Local infiltration group | Experimental | Procedure: Local infiltration grouppatients would have 0.5 ml/kg of 0.25% bupivacaine if age < 6 months or 1 ml/kg if age > 6 months around the wound by surgeon. The needle will be injected in subcutaneous tissue parallel to the wound. |
| TAP block group | Experimental | Procedure: TAP blockSurgical TAP block (sTAP: Patients would have 0.5 ml/kg of 0.25% bupivacaine if age < 6 months or 1 ml/kg if age > 6 months |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age < 15 year
- ASA I-III
- Abdominal surgery : all upper abdomen and lower abdomen which would have midline incision
- Elective surgery
Key exclusion criteria (3 listed)
- Allergic to Lidocaine or bupivacaine
- Delayed development
- Major abdominal surgery within 2 year
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 |
|---|---|---|
| Local infiltration groupAlso: local anesthetic infiltrationpatients would have 0.5 ml/kg of 0.25% bupivacaine if age < 6 months or 1 ml/kg if age > 6 months around the wound by surgeon. The needle will be injected in subcutaneous tissue parallel to the wound. | Procedure or surgery | Local infiltration group |
| TAP blockAlso: surgical transversus abdominis plane blockSurgical TAP block (sTAP: Patients would have 0.5 ml/kg of 0.25% bupivacaine if age < 6 months or 1 ml/kg if age > 6 months | Procedure or surgery | TAP block group |
| No interventionNo intervention | Other | No intervention |
Primary outcome
opioids consumption
Time frame: 24 hours
total opioids consumption in first 24 hours postoperatively
1 secondary outcome
Time to first analgesic
Time frame: 24 hr
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 31 Jul 2014.
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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.
Saowaphak Lapmahapaisan, M.D. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local infiltration group and TAP block in people with Child, run by Mahidol University at 1 site in Thailand.
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 4 inclusion and 3 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 31 Jul 2014. 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 Thailand. 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.
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?
opioids consumption (time frame: 24 hours). 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 31 Jul 2014.