Skip to content

Opioid-Free Anesthesia Based on Paravertebral Block of Thoracotomic Pediatric Congenital Surgery Necessitating Cardiopulmonary Bypass – Effectiveness of Postoperative Analgesia: A Prospective, Single-Blinded, Randomized Controlled Trial

Opioid-Free Anesthesia Based on Paravertebral Block of Thoracotomic Pediatric Congenital Surgery Necessitating Cardiopulmonary Bypass – Effectiveness of Postoperative Analgesia: A Prospective, Single-Blinded, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066517
Enrollment
Unknown
Registered
2022-12-07
Start date
2022-12-15
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital heart disease

Interventions

Experimental group:para vertebral block
Control group:conventional fast track anesthesia

Sponsors

Fuwai Yunnan Cardiovascular Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Children aged from 1 to 6 years; 2. Cardiopulmonary bypass repair of atrial septal defect and/or ventricular septal defect with right chest wall incision in left decubitus position; 3. Informed consent signed by the child's parents or legal guardians.

Exclusion criteria

Exclusion criteria: 1. Preoperative intravenous use of positive inotropic drugs, tracheal intubation or mechanical circulation AIDS; 2. Emergency surgery or secondary heart surgery; 3. Weight of children 30kg; 4. The patient was diagnosed with severe pulmonary hypertension after preoperative evaluation; 5. The last preoperative echocardiography showed that the left ventricular ejection fraction was less than 45%; 6. The child was allergic to ropivacaine or drugs routinely used during and after surgery; 7. Preoperative platelet count was lower than 100x10^9/L or coagulation function was abnormal (PT was longer than the normal high value for 3s; INR>1.5; APTT more than 10s longer than the normal high value); Or the child has a bleeding tendency (including gingival bleeding, skin ecchymosis, poor blood coagulation by venipuncture, etc.); 8. Preoperative use of antiplatelet drugs or anticoagulant drugs; 9. Contraindications of spinal deformity or other paravertebral block in the patient.

Design outcomes

Primary

MeasureTime frame
the opioids consumption within 24 hours after operation;

Secondary

MeasureTime frame
FLACC Scale Score;The rate of opioid treatment for remedial analgesia between groups;The first time of FLACC>=4 after end of surgery;The incidence of excessive hemodynamic fluctuation after incising in both groups;Serum concentration of inflammation factors (IL-6, IL-8, IL-10);Stress hormones (cortisol, epinephrine and norepinephrine);The rate of postoperative nausea and vomiting (PONV) during the 24h after end of surgery;The incidence of respiratory depression;Length of endotracheal intubation;Length of postoperative ICU stay;Length of postoperative hospital stay;

Countries

China

Contacts

Public ContactJia Yuan

Fuwai Yunnan Cardiovascular Hospital

jiayuan2009@163.com+86 13810098077

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026