AnesthesiaNCT01243593
Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery
A study testing Transversus Abdominis Plane Block and Standard Anesthesia in people with Anesthesia, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the effectiveness of transversus abdominis plane (TAP) block in reducing postoperative opioid requirements and pain after open pyeloplasty surgery in children. Read more about this study
- Who is it for?
- Ages 1 month to 6 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Transversus Abdominis Plane Block and Standard Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2010to Nov 2014
- 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 1 month to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists (ASA) classification score 1-3
- age 1 month to 6 years inclusive
Who cannot join
- children undergoing an additional surgical procedure at an anatomical location not covered by a 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 requiring opioid analgesics
- children with known renal insufficiency
Show all 9Show fewer
- children with known impaired hepatic function
- children with known impaired cardiac function
- children known hypersensitivity to sodium metabisulfite
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effectiveness of transversus abdominis plane (TAP) block in reducing postoperative opioid requirements and pain after open pyeloplasty surgery in children.
Read the detailed description
Primary open pyeloplasty is a common elective surgical procedure at The Hospital for Sick Children. All children are given fentanyl plus local anesthetic wound infiltration for intraoperative analgesia. A retrospective audit demonstrated that 63% of children required additional opioid treatment in the early recovery period following surgery. Concern exists regarding potential side effects of opioids including nausea or vomiting, respiratory depression, pruritus, over-sedation and delayed transition to oral intake. More importantly, 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, such as a TAP block, may benefit children undergoing open pyeloplasty.
The ultrasound guided TAP block introduces a local anaesthetic to the transversus abdominis plane which is one of three muscle layers in the abdominal wall. This results in a block of the nerves leading to the abdominal wall thereby reducing pain sensations.
- Conditions
- Anesthesia
- Being tested
- Transversus Abdominis Plane Block, Standard Anesthesia
- Keywords
- pediatrics, anesthesia, pyeloplasty, Transversus Abdominis Plane Block, Regional Anesthesia
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 block needle will be advanced in a medial to lateral direction 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.
Standard AnesthesiaProcedure or surgery
Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Procedure: Transversus Abdominis Plane Block |
| Control Group | Active comparator | Not described Receives: Procedure: Standard Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Requirement for Morphine Post-surgery.
The primary outcome measure will be the count and percentage of children who require morphine in the recovery room.
Measured: Time in recovery room, approximately 60-90 minutes.
Secondary outcomes (2)
Total Amount of Morphine (mg/kg) Administered in the Recovery Room.
Patients will receive intravenous morphine 0.05 mg/kg if the FLACC is ≥ 3/10 (equivalent to mild-to-moderate pain). Morphine may be given at 10 minute intervals as per standard protocol until the FLACC score is < 3/10, or the child declines additional pain medicine when offered.
Measured: Time in recovery room, approximately 60-90 minutes.
Assessment of First Pain Score on Arrival to Recovery Room.
Pain scores will be assessed using the Faces-Legs-Activity-Cry-Consolibility (FLACC) scale for children ≤ 7 years old. The FLACC scale is from 0-10 (0=no pain, 10=worst pain). The scale is composed of five subscales (Faces = facial expression; Legs = lower extremity movement; Activity = degree of movement; Cry = how upset the child is; Consolibity = how easy the child can be consoled). Eacg subscale is rated 0 to 2 (0 = rated as comfortable, no or minimal discomfort for that subscale; 2 = rated as uncomfortable, in pain according to that subscale). The subscales are summed to give a composite score out of 10. Pain scores will be assessed at admission to the recovery room.
Measured: On arrival to recovery room.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2014
- Study completionNov 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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, Investigator, Outcomes assessor
- Enrolment
- 32 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
- NCT01243593
- Sponsor's protocol ID
- 1000019942
- Status last verified
- Feb 2021
- First submitted
- 17 Nov 2010
- Last updated
- 4 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lorenzo AJ, Lynch J, Matava C, El-Beheiry H, Hayes J. Ultrasound guided transversus abdominis plane vs surgeon administered intraoperative regional field infiltration with bupivacaine for early postoperative pain control in children undergoing open pyeloplasty. J Urol. 2014 Jul;192(1):207-13. doi: 10.1016/j.juro.2014.01.026. Epub 2014 Feb 8.
PubMed 24518763
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery
- ClinicalTrials.gov ID
- NCT01243593
- Acronym / sponsor ID
- 1000019942
- Conditions
- Anesthesia
- Keywords
- pediatrics, anesthesia, pyeloplasty, Transversus Abdominis Plane Block, Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 18 Nov 2010 (estimated)
- Results
- Posted 4 Feb 2021
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 evaluate the effectiveness of transversus abdominis plane (TAP) block in reducing postoperative opioid requirements and pain after open pyeloplasty surgery in children.
Detailed description
Primary open pyeloplasty is a common elective surgical procedure at The Hospital for Sick Children. All children are given fentanyl plus local anesthetic wound infiltration for intraoperative analgesia. A retrospective audit demonstrated that 63% of children required additional opioid treatment in the early recovery period following surgery. Concern exists regarding potential side effects of opioids including nausea or vomiting, respiratory depression, pruritus, over-sedation and delayed transition to oral intake. More importantly, 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, such as a TAP block, may benefit children undergoing open pyeloplasty.
The ultrasound guided TAP block introduces a local anaesthetic to the transversus abdominis plane which is one of three muscle layers in the abdominal wall. This results in a block of the nerves leading to the abdominal wall thereby reducing pain sensations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Procedure: Transversus Abdominis Plane Block |
| Control Group | Active comparator | Procedure: Standard Anesthesia |
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) classification score 1-3
- age 1 month to 6 years inclusive
Key exclusion criteria (9 listed)
- children undergoing an additional surgical procedure at an anatomical location not covered by a 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 requiring opioid analgesics
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 block needle will be advanced in a medial to lateral direction 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 |
| Standard AnesthesiaLocal field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision. | Procedure or surgery | Control Group |
Primary outcome
Requirement for Morphine Post-surgery.
Time frame: Time in recovery room, approximately 60-90 minutes.
The primary outcome measure will be the count and percentage of children who require morphine in the recovery room.
2 secondary outcomes
Total Amount of Morphine (mg/kg) Administered in the Recovery Room.
Time frame: Time in recovery room, approximately 60-90 minutes.
Assessment of First Pain Score on Arrival to Recovery Room.
Time frame: On arrival to recovery room.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24518763Lorenzo AJ, Lynch J, Matava C, El-Beheiry H, Hayes J. Ultrasound guided transversus abdominis plane vs surgeon administered intraoperative regional field infiltration with bupivacaine for early postoperative pain control in children undergoing open pyeloplasty. J Urol. 2014 Jul;192(1):207-13. doi: 10.1016/j.juro.2014.01.026. Epub 2014 Feb 8.
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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 Anesthesia in people with Anesthesia, 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 2 inclusion and 9 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 4 Feb 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 4 Feb 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?
Requirement for Morphine Post-surgery. (time frame: Time in recovery room, approximately 60-90 minutes.). 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 NCT01243593, which also lists 1 linked publication.
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 4 Feb 2021.