Analgesia, Nerve Block, Pectus Excavatum
Conditions
Brief summary
This is a prospective randomized double-blind non-inferiority trial designed to test the hypothesis that erector spinae plane block (ESPB) is non-inferior to thoracic paravertebral block (TPVB) in postoperative pain control after pectus excavatum repair.
Interventions
PROCEDUREESPB group
A 21-gauge 100-mm needle will be inserted into the fascial layer beneath the iliocostalis, longissimus, and spinalis muscles. A bolus of 0.25% ropivacaine 0.5 ml/kg will be injected into the fascial layer. Contralateral ESPB will be performed similarly.
PROCEDURETPVB group
A 21-gauge 100-mm insulated needle will be inserted into the paravertebral space via an in-plane parasagittal approach. After perforating the costotransverse ligament, 0.25% ropivacaine 0.5 ml/kg will be injected. Anterior movement of the pleura indicated the appropriate spread of the local anesthetics in the paravertebral space. The process will be repeated on the contralateral side.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age between 4 to 18 years Scheduled for elective Nuss surgery Written informed consent is obtained from parents of each patient.
Exclusion criteria
* Coagulation dysfunction. American Society of Anesthesiologists Physical Status 4 or 5. Allergy to study medication. Local infection at the site of injection or systemic infection. Inability to understand Chinese.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores at rest at 24 hours postoperatively | 24 hours postoperatively | Pain scores will be recorded using the Numeric Rating Scale (NRS) scores (0-10). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total rescue morphine-equivalent consumption per weight | at 24 and 48 hours after surgery | total rescue morphine-equivalent consumption per weight at predetermined time intervals (24 and 48 hours) after surgery |
| Emergence agitation at 5, 15, 30 min after extubation | at 5, 15, 30 min after extubation | Emergence agitation will be registered using pediatric anesthesia emergence delirium (PAED) at 5, 15, 30 min after extubation |
| Total dosage of intraoperative sufentanil and remifentanil | during surgery | Total dosage of intraoperative sufentanil and remifentanil per weight |
| The pain degree at rest and after movement or coughing(dynamic) | at 3, 6, 12, 24, and 48 hours after surgery | The pain degree at rest and after movement or coughing at 3, 6, 12, 24, and 48 hours after surgery respectively. |
| The time to first mobilization | within the 3 days after surgery | Time from operation to ambulation |
| Side effects | within the 5 days after surgery | Side effects such as pneumothorax, local anesthetic toxicity, postoperative nausea and vomiting |
| The time to first analgesia request | within the 3 days after surgery | Time from operation to first rescue analgesia request |
Countries
China
Outcome results
None listed