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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental |
| |
| Control Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transversus Abdominis Plane Block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Requirement for Morphine Post-surgery. | The primary outcome measure will be the count and percentage of children who require morphine in the recovery room. | Time in recovery room, approximately 60-90 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Time in recovery room, approximately 60-90 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Hayes, MD | The Hospital for Sick Children, Toronto Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24518763 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | Transversus Abdominis Plane Block: 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. |
| FG001 | Control Group | Standard Anesthesia: Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | Transversus Abdominis Plane Block: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Requirement for Morphine Post-surgery. | The primary outcome measure will be the count and percentage of children who require morphine in the recovery room. | Posted | Count of Participants | Participants | Time in recovery room, approximately 60-90 minutes. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | Transversus Abdominis Plane Block: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Hayes | Sick Kids Hospital | 416-813-7445 | jason.hayes@sickkids.ca |
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|
| Standard Anesthesia | Procedure | Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision. |
|
| 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. | On arrival to recovery room. |
| BG001 | Control Group | Standard Anesthesia: Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision. |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mg/kg | Time in recovery room, approximately 60-90 minutes. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on FLACC pain scale | On arrival to recovery room. |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Control Group | Standard Anesthesia: Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision. | 0 | 16 | 0 | 16 |
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