Anesthesia, Recovery PeriodPhase 4NCT02160821
TAPB vs. Caudal for Lower Abdominal Surgery in Children: A Double-Blinded Randomized Controlled Trial
A Phase 4 study testing Caudal Epidural and Transversus Abdominis Plane Block in people with Anesthesia, Recovery Period, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
Transversus abdominis plane block (TAPB) has emerged as a safe and effective regional anesthesia technique for providing postoperative lower abdominal analgesia. Complications associated with TAPB are very rare and pose a lower overall risk to the patient receiving a TAPB versus a caudal block, which is considered the… Read more about this study
- Who is it for?
- Ages 1 year to 9 years
- Conditions the study is for
- Anesthesia, Recovery Period
- What is being tested?
- Caudal Epidural and Transversus Abdominis Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2014
- 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 1 year to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 1 to 9 years old scheduled for intravesicular ureteral reimplantation surgery
Who cannot join
- Coagulation status or anatomic variations precluded safe placement of either TAPB or caudal epidural,
- there was a preexisting chronic pain disorder,
- there was a history of constipation that persisted despite appropriate treatment and that may have impacted postoperative pain assessments,
- additional procedures were planned via a separate incision at the time of the ureteral reimplantation, 5) there was a contraindication to receiving the medications described in the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wolfson Children's Hospital, Baptist Medical Center- Downtown, 800 Prudential Drive
Jacksonville, Florida, 32207
About this study
Official title: Transversus Abdominis Plane Block Versus Caudal Epidural for Lower Abdominal Surgery in Children: A Double-Blinded Randomized Controlled Trial
Transversus abdominis plane block (TAPB) has emerged as a safe and effective regional anesthesia technique for providing postoperative lower abdominal analgesia. Complications associated with TAPB are very rare and pose a lower overall risk to the patient receiving a TAPB versus a caudal block, which is considered the gold standard for pediatric lower abdominal regional anesthesia. Our study hypothesis was that TAPB would be equivalent to caudal block initially in providing postoperative pain control but would show improved pain relief beyond the anticipated caudal duration.
Read the detailed description
The study design was a double-blinded randomized controlled trial. A minimum of 44 children between the ages of 1 and 9 undergoing bilateral ureteral reimplantation surgery through a low transverse incision will be enrolled. Narcotic requirement, pain scores (FLACC/FACES), episodes of nausea/vomiting, and anti-spasmodic requirement will be recorded in the PACU and at 6 hour intervals through 24 hours from the time of the block placement.
- Conditions
- Anesthesia, Recovery Period
- Being tested
- Caudal Epidural, Transversus Abdominis Plane Block
- Keywords
- Transversus Abdominis Plane Block, Caudal Epidural, Pediatric Pain control, Pain control for Lower Abdominal Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal EpiduralProcedure or surgery
Ultrasound Guided Caudal Block
Transversus Abdominis Plane BlockProcedure or surgery
Ultrasound Guided Transversus Abdominis Plane Block
| Study group | Role | What they receive |
|---|---|---|
| Transversus Abdominis Plane Block | Experimental | Transversus Abdominis Plane Block TAPB Ultrasound guided TAPB Receives: Procedure: Transversus Abdominis Plane Block |
| Caudal Epidural Block | Experimental | Caudal Epidural Block Caudal Block Neuraxial Block Ultrasound Guided Caudal Block Receives: Procedure: Caudal Epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcotic requirement
Narcotic requirement was recorded at 24 hours from the time of the block placement.
Measured: 24 hours post intervention
Secondary outcomes (3)
episodes of nausea/vomiting
Episodes of nausea/vomiting were recorded at 24 hours from the time of the block placement.
Measured: 24 hours
anti-spasmodic requirement
Anti-spasmodic requirement were recorded at 24 hours from the time of the block placement.
Measured: 24 hours post intervention
Pain Scores
Pain scores (FLACC/FACES) were recorded at 24 hours from the time of the block placement
Measured: 24 hours post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, Recovery PeriodStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert B Bryskin, MD, Principal investigator, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160821
- Sponsor's protocol ID
- 1610841001
- Status last verified
- Jun 2014
- First submitted
- 29 May 2014
- Last updated
- 11 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Tripi PA, Palmer JS, Thomas S, Elder JS. Clonidine increases duration of bupivacaine caudal analgesia for ureteroneocystostomy: a double-blind prospective trial. J Urol. 2005 Sep;174(3):1081-3. doi: 10.1097/01.ju.0000169138.90628.b9.
PubMed 16094063Vetter TR, Carvallo D, Johnson JL, Mazurek MS, Presson RG Jr. A comparison of single-dose caudal clonidine, morphine, or hydromorphone combined with ropivacaine in pediatric patients undergoing ureteral reimplantation. Anesth Analg. 2007 Jun;104(6):1356-63, table of contents. doi: 10.1213/01.ane.0000261521.52562.de.
PubMed 17513626Bryskin RB, Londergan B, Wheatley R, Heng R, Lewis M, Barraza M, Mercer E, Ye G. Transversus Abdominis Plane Block Versus Caudal Epidural for Lower Abdominal Surgery in Children: A Double-Blinded Randomized Controlled Trial. Anesth Analg. 2015 Aug;121(2):471-8. doi: 10.1213/ANE.0000000000000779.
PubMed 25902326
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane Block Versus Caudal Epidural for Lower Abdominal Surgery in Children: A Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02160821
- Acronym / sponsor ID
- 1610841001
- Conditions
- Anesthesia, Recovery Period
- Keywords
- Transversus Abdominis Plane Block, Caudal Epidural, Pediatric Pain control, Pain control for Lower Abdominal Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 11 Jun 2014 (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.
Transversus abdominis plane block (TAPB) has emerged as a safe and effective regional anesthesia technique for providing postoperative lower abdominal analgesia. Complications associated with TAPB are very rare and pose a lower overall risk to the patient receiving a TAPB versus a caudal block, which is considered the gold standard for pediatric lower abdominal regional anesthesia. Our study hypothesis was that TAPB would be equivalent to caudal block initially in providing postoperative pain control but would show improved pain relief beyond the anticipated caudal duration.
Detailed description
The study design was a double-blinded randomized controlled trial. A minimum of 44 children between the ages of 1 and 9 undergoing bilateral ureteral reimplantation surgery through a low transverse incision will be enrolled. Narcotic requirement, pain scores (FLACC/FACES), episodes of nausea/vomiting, and anti-spasmodic requirement will be recorded in the PACU and at 6 hour intervals through 24 hours from the time of the block placement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversus Abdominis Plane Block | Experimental | Procedure: Transversus Abdominis Plane BlockTransversus Abdominis Plane Block TAPB Ultrasound guided TAPB |
| Caudal Epidural Block | Experimental | Procedure: Caudal EpiduralCaudal Epidural Block Caudal Block Neuraxial Block Ultrasound Guided Caudal Block |
Who may qualify
- Ages
- 1 year to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients aged 1 to 9 years old scheduled for intravesicular ureteral reimplantation surgery
Key exclusion criteria (4 listed)
- Coagulation status or anatomic variations precluded safe placement of either TAPB or caudal epidural,
- there was a preexisting chronic pain disorder,
- there was a history of constipation that persisted despite appropriate treatment and that may have impacted postoperative pain assessments,
- additional procedures were planned via a separate incision at the time of the ureteral reimplantation, 5) there was a contraindication to receiving the medications described in the protocol.
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 |
|---|---|---|
| Caudal EpiduralUltrasound Guided Caudal Block | Procedure or surgery | Caudal Epidural Block |
| Transversus Abdominis Plane BlockUltrasound Guided Transversus Abdominis Plane Block | Procedure or surgery | Transversus Abdominis Plane Block |
Primary outcome
Narcotic requirement
Time frame: 24 hours post intervention
Narcotic requirement was recorded at 24 hours from the time of the block placement.
3 secondary outcomes
episodes of nausea/vomiting
Time frame: 24 hours
anti-spasmodic requirement
Time frame: 24 hours post intervention
Pain Scores
Time frame: 24 hours post intervention
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 11 Jun 2014.
- Background: PubMed 16094063Tripi PA, Palmer JS, Thomas S, Elder JS. Clonidine increases duration of bupivacaine caudal analgesia for ureteroneocystostomy: a double-blind prospective trial. J Urol. 2005 Sep;174(3):1081-3. doi: 10.1097/01.ju.0000169138.90628.b9.
- Background: PubMed 17513626Vetter TR, Carvallo D, Johnson JL, Mazurek MS, Presson RG Jr. A comparison of single-dose caudal clonidine, morphine, or hydromorphone combined with ropivacaine in pediatric patients undergoing ureteral reimplantation. Anesth Analg. 2007 Jun;104(6):1356-63, table of contents. doi: 10.1213/01.ane.0000261521.52562.de.
- Derived from this study: PubMed 25902326Bryskin RB, Londergan B, Wheatley R, Heng R, Lewis M, Barraza M, Mercer E, Ye G. Transversus Abdominis Plane Block Versus Caudal Epidural for Lower Abdominal Surgery in Children: A Double-Blinded Randomized Controlled Trial. Anesth Analg. 2015 Aug;121(2):471-8. doi: 10.1213/ANE.0000000000000779.
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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.
Robert B Bryskin, MD principal investigator
Nemours Children's Clinic
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 Caudal Epidural and Transversus Abdominis Plane Block in people with Anesthesia, Recovery Period, run by Nemours Children's Clinic at 1 site in United States.
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 1 inclusion and 4 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 11 Jun 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 United States. 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?
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?
Narcotic requirement (time frame: 24 hours post intervention). 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 NCT02160821, which also lists 3 linked publications.
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 11 Jun 2014.