AnesthesiaNCT01136668
Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery
A study testing Transversus Abdominis Plane Block and Standard in people with Anesthesia and Ostomy, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The primary objective of this study is to determine if the use of Transversus Abdominis Plane (TAP) blocks reduce early postoperative opioid requirements. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Anesthesia, Ostomy
- What is being tested?
- Transversus Abdominis Plane Block and Standard
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children undergoing revision or closure of ostomy
- American Society of Anesthesiologists Classification 1-3.
- age ≥ 3 months
Who cannot join
- children undergoing an additional surgical procedure (e.g. circumcision) at an anatomical location not covered by a one-sided/ unilateral TAP block, during the same anesthetic
- children in whom a TAP block is contraindicated, i.e. surgical scar or distorted anatomy at the site of injection
- postoperative admission to the intensive care unit
- children with a known allergy to bupivacaine
- children with a history of chronic abdominal pain
- use of opioid analgesics prior to surgery
Show all 11Show fewer
- pregnancy
- impaired renal function
- impaired hepatic function
- known impaired cardiac function
- hypersensitivity to sodium metabisulfite
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery: A Prospective Randomized Controlled Trial
The primary objective of this study is to determine if the use of Transversus Abdominis Plane (TAP) blocks reduce early postoperative opioid requirements.
Read the detailed description
Revision or closure of ostomy is a common elective surgical procedure at The Hospital for Sick Children. A retrospective audit conducted at SickKids demonstrated significant intraoperative opioid use and significant requirements for rescue opioids in recovery.
Concerns exist regarding the relative merits of opioid use in abdominal surgery. Opioids may decrease bowel motility leading to the increased incidence and duration of postoperative ileus. They may be associated with increased rates of post-operative nausea and vomiting and pruritus. Lastly children may under-report their pain or pain may not be recognized by medical staff leading to inadequate provision of analgesia. This suggests that the use of a regional technique may benefit children undergoing revision of ostomy.
- Conditions
- Anesthesia, Ostomy
- Being tested
- Transversus Abdominis Plane Block, Standard
- Keywords
- pediatrics, Transversus Abdominis Plane Block, Ostomy Surgery, Anesthesia, Regional Anesthetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus Abdominis Plane BlockProcedure or surgery
A high frequency (5-10 mHz) ultrasound probe (Sonosite Micromaxx, Licence No 12407) will be placed on the flank at the midpoint between the iliac crest and lower costal margin. The three muscle layers of external oblique, internal oblique, and transversus abdominis will be visualized. A 22G short-bevel block needle will be advanced in an anterior-to-posterior direction, in-plane with the probe, until the tip is visualized in the transversus abdominis plane. After negative aspiration, 0.4 ml/kg of bupivacaine 0.25% with 1:200,000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.
StandardProcedure or surgery
Circumferential subcutaneous infiltration of the ostomy wound with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg by the surgeon after skin closure.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Bupivacine-TAP block Receives: Procedure: Transversus Abdominis Plane Block |
| Control Group | Active comparator | Bupivacaine- wound infiltration Receives: Procedure: Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Requirement
The primary endpoint will be the proportion of children in each group requiring two or more (≥ 2) boluses of morphine in the PACU.
Measured: within the first 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startApr 2010
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Unable to recruit adequate number of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Hayes, The Hospital for Sick Children
- Investigators
- Jason Hayes, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136668
- Sponsor's protocol ID
- 1000014754
- Status last verified
- May 2021
- First submitted
- 2 Jun 2010
- Last updated
- 8 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane Block in Children Undergoing Ostomy Surgery: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01136668
- Acronym / sponsor ID
- 1000014754
- Conditions
- Anesthesia, Ostomy
- Keywords
- pediatrics, Transversus Abdominis Plane Block, Ostomy Surgery, Anesthesia, Regional Anesthetic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit adequate number of subjects
- Enrolment
- 13 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Posted 8 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine if the use of Transversus Abdominis Plane (TAP) blocks reduce early postoperative opioid requirements.
Detailed description
Revision or closure of ostomy is a common elective surgical procedure at The Hospital for Sick Children. A retrospective audit conducted at SickKids demonstrated significant intraoperative opioid use and significant requirements for rescue opioids in recovery.
Concerns exist regarding the relative merits of opioid use in abdominal surgery. Opioids may decrease bowel motility leading to the increased incidence and duration of postoperative ileus. They may be associated with increased rates of post-operative nausea and vomiting and pruritus. Lastly children may under-report their pain or pain may not be recognized by medical staff leading to inadequate provision of analgesia. This suggests that the use of a regional technique may benefit children undergoing revision of ostomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Procedure: Transversus Abdominis Plane BlockBupivacine-TAP block |
| Control Group | Active comparator | Procedure: StandardBupivacaine- wound infiltration |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- children undergoing revision or closure of ostomy
- American Society of Anesthesiologists Classification 1-3.
- age ≥ 3 months
Key exclusion criteria (11 listed)
- children undergoing an additional surgical procedure (e.g. circumcision) at an anatomical location not covered by a one-sided/ unilateral TAP block, during the same anesthetic
- children in whom a TAP block is contraindicated, i.e. surgical scar or distorted anatomy at the site of injection
- postoperative admission to the intensive care unit
- children with a known allergy to bupivacaine
- children with a history of chronic abdominal pain
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 |
|---|---|---|
| Transversus Abdominis Plane BlockA high frequency (5-10 mHz) ultrasound probe (Sonosite Micromaxx, Licence No 12407) will be placed on the flank at the midpoint between the iliac crest and lower costal margin. The three muscle layers of external oblique, internal oblique, and transversus abdominis will be visualized. A 22G short-bevel block needle will be advanced in an anterior-to-posterior direction, in-plane with the probe, until the tip is visualized in the transversus abdominis plane. After negative aspiration, 0.4 ml/kg of bupivacaine 0.25% with 1:200,000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml. | Procedure or surgery | Treatment group |
| StandardCircumferential subcutaneous infiltration of the ostomy wound with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg by the surgeon after skin closure. | Procedure or surgery | Control Group |
Primary outcome
Morphine Requirement
Time frame: within the first 48 hours after surgery
The primary endpoint will be the proportion of children in each group requiring two or more (≥ 2) boluses of morphine in the PACU.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jason Hayes, MD principal investigator
The Hospital for Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus Abdominis Plane Block and Standard in people with Anesthesia and Ostomy, run by The Hospital for Sick Children at 1 site in Canada.
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 11 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: stopped early, as of the sponsor's last update on 8 Jun 2021. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 8 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Morphine Requirement (time frame: within the first 48 hours after 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 8 Jun 2021.