Postoperative Pain
Conditions
Keywords
Postoperative analgesia, paravertebral block, pediatric cardiac surgery, enhanced recovery after surgery
Brief summary
This study aims to compare the effect of paravertebral block and local infiltration anesthesia on postoperative analgesia in children undergoing lateral incision cardiac surgery with cardiopulmonary bypass. The researchers hope to investigate whether children who undergo paravertebral block experience less postoperative pain, have fewer postoperative complications, and recover more quickly.
Interventions
PROCEDUREparavertebral block
After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct paravertebral block.
PROCEDURELocal infiltration anesthesia
After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct local infiltration anesthesia.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
1. Children aged 6-14 years old; 2. Children who have atrial septal defect or ventricular septal defect scheduled for lateral incision cardiac surgery with cardiopulmonary bypass; 3. Inform consent signed by the parent or legal guardian.
Exclusion criteria
1. Patients who were intubated, on mechanical circulatory support, or with intravenous inotropes before surgery; 2. Emergency surgery or redo cardiac surgery; 3. Body weight more than 50kg; 4. Diagnosed as severe pulmonary hypertension; 5. Left ventricular ejection fraction less than 45% in most recent echocardiography before surgery; 6. Allergic to ropivacaine or other regular anesthetics, analgesics or other medications regularly used in the study; 7. Preoperative platelet counts less than 100\*109/L, coagulopathy or bleeding tendency ; 8. Preoperatively using antiplatelets or anticoagulants; 9. Diagnosed with scoliosis or other contraindications for PVB.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| opioid consumption during the first 24h after surgery | 24 hours postoperatively | the total amount of sufentanil and other opioids will be calculated as morphine equivalent dose (MED) divided by body weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FPS-R scale recorded at 6, 12, 18 and 24h postoperatively | 24 hours postoperatively | The Faces Pain Scale-Revised (FPS-R) is a self-report measure of pain intensity developed for children. It was adapted from the Faces Pain Scale to make it possible to score the sensation of pain on the widely accepted 0-to-10 metric. The scale shows a close linear relationship with visual analog pain scales across the age range of 4-16 years. The bedside nurse will show the patients a picture of six faces, and score 0, 2, 4, 6, 8, and 10 from left to right. 0 equals no pain and 10 equals very much pain. They will ask the patient to choose a face that represents their current pain condition and record the pain score. |
| The rate of opioid treatment for remedial analgesia between groups | 24 hours postoperatively | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of postoperative mechanical ventilation | through study completion, an average of 2 weeks | — |
| The rate of postoperative nausea and vomiting (PONV) during the 24h postoperatively | through study completion, an average of 2 weeks | — |
| Length of ICU/hospital stay | through study completion, an average of 2 weeks | — |
| The incidence of respiratory depression | through study completion, an average of 2 weeks | The respiratory depression is defined as: with no obvious upper respiratory tract obstruction: SpO2 \< 90% and lasts for more than one minute, or respiratory rate \< 8 times/min, or SpO2 \< 94% and respiratory rate \< 10 times/min, or supplemental oxygen is needed to maintain SpO2 \> 94%. |
Countries
China
Outcome results
None listed