Postoperative PainNCT06312904
Paravertebral Block for Postoperative Analgesia in Children Undergoing Lateral Incision Cardiac Surgery With CBP
A study testing paravertebral block and Local infiltration anesthesia in people with Postoperative Pain, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- paravertebral block and Local infiltration anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2024to 14 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-14 years old;
- Children who have atrial septal defect or ventricular septal defect scheduled for lateral incision cardiac surgery with cardiopulmonary bypass;
- Inform consent signed by the parent or legal guardian.
Who cannot join
- Patients who were intubated, on mechanical circulatory support, or with intravenous inotropes before surgery;
- Emergency surgery or redo cardiac surgery;
- Body weight more than 50kg;
- Diagnosed as severe pulmonary hypertension;
- Left ventricular ejection fraction less than 45% in most recent echocardiography before surgery;
- Allergic to ropivacaine or other regular anesthetics, analgesics or other medications regularly used in the study;
Show all 9Show fewer
- Preoperative platelet counts less than 100*109/L, coagulopathy or bleeding tendency ;
- Preoperatively using antiplatelets or anticoagulants;
- Diagnosed with scoliosis or other contraindications for PVB.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Paravertebral Block on Postoperative Analgesia in Children Undergoing Lateral Incision Cardiac Surgery With Cardiopulmonary Bypass: a Randomized Controlled Trial
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.
- Conditions
- Postoperative Pain
- Being tested
- paravertebral block, Local infiltration anesthesia
- Keywords
- Postoperative analgesia, paravertebral block, pediatric cardiac surgery, enhanced recovery after surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paravertebral blockProcedure or surgery
After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct paravertebral block.
Local infiltration anesthesiaProcedure or surgery
After cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct local infiltration anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| paravertebral block group | Experimental | This group of patients will undergo postoperative paravertebral block. Receives: Procedure: paravertebral block |
| local infiltration group | Active comparator | This group of patients will undergo postoperative local infiltration anesthesia. Receives: Procedure: Local infiltration anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours postoperatively
Secondary outcomes (2)
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.
Measured: 24 hours postoperatively
The rate of opioid treatment for remedial analgesia between groups
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start11 Mar 2024
- Primary completion9 Aug 2024
- Study completion14 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingfei Guo, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Jingfei Guo, Study chair, Fuwai Hospital, National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312904
- Sponsor's protocol ID
- 2023-GSP-QN-7
- Status last verified
- Feb 2025
- First submitted
- 29 Feb 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The original data will be published in 2025 on http://www.medresman.org.cn
Publications
Guo J, Tian L, Kang W, Jia Y, Yuan S. Effects of paravertebral block on postoperative analgesia in children undergoing unilateral thoracotomy cardiac surgery with cardiopulmonary bypass: protocol for a randomised controlled trial. BMJ Open. 2024 Nov 7;14(11):e086462. doi: 10.1136/bmjopen-2024-086462.
PubMed 39510785
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Paravertebral Block on Postoperative Analgesia in Children Undergoing Lateral Incision Cardiac Surgery With Cardiopulmonary Bypass: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06312904
- Acronym / sponsor ID
- 2023-GSP-QN-7
- Conditions
- Postoperative Pain
- Keywords
- Postoperative analgesia, paravertebral block, pediatric cardiac surgery, enhanced recovery after surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 9 Aug 2024 (actual)
- Study completion
- 14 Aug 2024 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paravertebral block group | Experimental | Procedure: paravertebral blockThis group of patients will undergo postoperative paravertebral block. |
| local infiltration group | Active comparator | Procedure: Local infiltration anesthesiaThis group of patients will undergo postoperative local infiltration anesthesia. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 6-14 years old;
- Children who have atrial septal defect or ventricular septal defect scheduled for lateral incision cardiac surgery with cardiopulmonary bypass;
- Inform consent signed by the parent or legal guardian.
Key exclusion criteria (9 listed)
- Patients who were intubated, on mechanical circulatory support, or with intravenous inotropes before surgery;
- Emergency surgery or redo cardiac surgery;
- Body weight more than 50kg;
- Diagnosed as severe pulmonary hypertension;
- Left ventricular ejection fraction less than 45% in most recent echocardiography before surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paravertebral blockAfter cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct paravertebral block. | Procedure or surgery | paravertebral block group |
| Local infiltration anesthesiaAfter cardiac surgery, the anesthesiologist will use 3mg/kg of 0.375% ropivacaine to conduct local infiltration anesthesia. | Procedure or surgery | local infiltration group |
Primary outcome
opioid consumption during the first 24h after surgery
Time frame: 24 hours postoperatively
the total amount of sufentanil and other opioids will be calculated as morphine equivalent dose (MED) divided by body weight
2 secondary outcomes
FPS-R scale recorded at 6, 12, 18 and 24h postoperatively
Time frame: 24 hours postoperatively
The rate of opioid treatment for remedial analgesia between groups
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Derived from this study: PubMed 39510785Guo J, Tian L, Kang W, Jia Y, Yuan S. Effects of paravertebral block on postoperative analgesia in children undergoing unilateral thoracotomy cardiac surgery with cardiopulmonary bypass: protocol for a randomised controlled trial. BMJ Open. 2024 Nov 7;14(11):e086462. doi: 10.1136/bmjopen-2024-086462.
- Individual participant dataSharing planned: Yes. The original data will be published in 2025 on http://www.medresman.org.cn
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingfei Guo study chair
Fuwai Hospital, National Center for Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paravertebral block and Local infiltration anesthesia in people with Postoperative Pain, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioid consumption during the first 24h after surgery (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06312904, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.