Anesthesia
Conditions
Keywords
pediatrics, anesthesia, pyeloplasty, Transversus Abdominis Plane Block, Regional Anesthesia
Brief 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.
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.
Interventions
PROCEDURETransversus 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.
PROCEDUREStandard Anesthesia
Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 6 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) classification score 1-3 * age 1 month to 6 years inclusive
Exclusion criteria
* 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 * children with known impaired hepatic function * children with known impaired cardiac function * children known hypersensitivity to sodium metabisulfite
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Requirement for Morphine Post-surgery. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Amount of Morphine (mg/kg) Administered in the Recovery Room. | Time in recovery room, approximately 60-90 minutes. | 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. |
| Assessment of First Pain Score on Arrival to Recovery Room. | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| Control Group Standard Anesthesia: Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision. | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | Control Group | Treatment Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 16 Participants | 32 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 1 years STANDARD_DEVIATION 0.3 | 0.7 years STANDARD_DEVIATION 0.2 | 0.85 years STANDARD_DEVIATION 1 |
| Sex: Female, Male Female | 9 Participants | 4 Participants | 13 Participants |
| Sex: Female, Male Male | 7 Participants | 12 Participants | 19 Participants |
| Weight | 9.2 kg STANDARD_DEVIATION 0.92 | 8.4 kg STANDARD_DEVIATION 0.62 | 8.7 kg STANDARD_DEVIATION 3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
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.
Time frame: Time in recovery room, approximately 60-90 minutes.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group | Requirement for Morphine Post-surgery. | 13 Participants |
| Control Group | Requirement for Morphine Post-surgery. | 6 Participants |
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.
Time frame: On arrival to recovery room.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Assessment of First Pain Score on Arrival to Recovery Room. | 5 units on FLACC pain scale | Standard Deviation 5 |
| Control Group | Assessment of First Pain Score on Arrival to Recovery Room. | 2 units on FLACC pain scale | Standard Deviation 3 |
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.
Time frame: Time in recovery room, approximately 60-90 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment Group | Total Amount of Morphine (mg/kg) Administered in the Recovery Room. | 0.07 mg/kg | Standard Deviation 0.05 |
| Control Group | Total Amount of Morphine (mg/kg) Administered in the Recovery Room. | 0.03 mg/kg | Standard Deviation 0.04 |