Umbilical Hernia
Conditions
Brief summary
The literature has clearly demonstrated that the effective treatment of postoperative pain in infants and children is challenging. In an effort to improve postoperative analgesia while limiting opioid-related adverse effects, there continues to be an increased use of regional anesthetic techniques in infants and children. Although the pediatric caudal remains the most commonly used pediatric regional anesthetic technique, it has been demonstrated that effective analgesia can be provided with the use of peripheral nerve blockade even in the pediatric-aged patient. The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing umbilical hernia repair who have received either a caudal block or bilateral rectus sheath blocks for analgesia
Interventions
DRUGBupivacaine
0.25% or 0.5%
Sponsors
Nationwide Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* ASA physical status I or II * Weight less than or equal to 20 kg * Presenting for repair of umbilical hernia
Exclusion criteria
* ASA physical status \> II * Weight greater than 20 kg * Co-morbid diseases (cardiac, pulmonary, neurological disease) * Patients having concomitant procedures (circumcision, orchiopexy, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain Score | 30 minutes | Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Caudal Epidural The caudal epidural block will be delivered with 1.5ml/kg of 0.25% Bupivacaine up to a maximum of 30 mL.
Bupivacaine: 0.25% or 0.5% | 13 |
| Rectus Sheath The rectus sheath block will be performed with 0.1ml/kg of 0.25% Bupivacaine on each side at the T9-T10 distribution under ultrasound guidance.
Bupivacaine: 0.25% or 0.5% | 13 |
| Local The surgeon will inject either 0.5% Bupivicaine 0.5ml/kg or 0.25% Bupivicaine 1ml/kg at the surgeon's discretion.
Bupivacaine: 0.25% or 0.5% | 13 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Unable to place block | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Caudal Epidural | Rectus Sheath | Local | Total |
|---|---|---|---|---|
| Age, Continuous | 4.2 years STANDARD_DEVIATION 1.5 | 4.3 years STANDARD_DEVIATION 1.6 | 4.6 years STANDARD_DEVIATION 1.2 | 4.4 years STANDARD_DEVIATION 1.4 |
| Sex: Female, Male Female | 6 Participants | 10 Participants | 6 Participants | 22 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 7 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 12 | 0 / 13 | 0 / 13 |
Outcome results
Primary
Post-operative Pain Score
Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain.
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Caudal Epidural | Post-operative Pain Score | 2.9 pain score | Standard Deviation 3.3 |
| Rectus Sheath | Post-operative Pain Score | 3.1 pain score | Standard Deviation 3.1 |
| Local | Post-operative Pain Score | 2.1 pain score | Standard Deviation 2.7 |