An interventional study of paravertebral block and Local infiltration anesthesia in Postoperative Pain, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Completed at 1 site in China. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Not applicable, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 100 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 141 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group of patients will undergo postoperative paravertebral block.
Procedure: paravertebral block
This group of patients will undergo postoperative local infiltration anesthesia.
Procedure: Local infiltration anesthesia
After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct paravertebral block.
After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct local infiltration anesthesia.
opioid consumption during the first 24h after surgery
the total amount of sufentanil and other opioids will be calculated as morphine equivalent dose (MED) divided by body weight
Time frame: 24 hours postoperatively
FPS-R scale recorded at 6, 12, 18 and 24h 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.
Time frame: 24 hours postoperatively
The rate of opioid treatment for remedial analgesia between groups
Time frame: 24 hours postoperatively
Length of postoperative mechanical ventilation
Time frame: through study completion, an average of 2 weeks
Length of ICU/hospital stay
Time frame: through study completion, an average of 2 weeks
The incidence of respiratory depression
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%.
Time frame: through study completion, an average of 2 weeks
The rate of postoperative nausea and vomiting (PONV) during the 24h postoperatively
Time frame: through study completion, an average of 2 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The original data will be published in 2025 on http://www.medresman.org.cn
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chinese Academy of Medical Sciences, Fuwai Hospital