Nerve BlockNCT05034601
ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure
A study testing ESPB group and TPVB group in people with Nerve Block and Analgesia, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Nerve Block, Analgesia, Pectus Excavatum
- What is being tested?
- ESPB group and TPVB group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2021to 23 Mar 2023
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 4 to 18 years Scheduled for elective Nuss surgery Written informed consent is obtained from parents of each patient.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, West China Hospital
Chengdu, Sichuan, 610041
About this study
Official title: Comparison of Erector Spinae Plane and Paravertebral Nerve Blocks for Postoperative Analgesia in Children After the Nuss Procedure
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.
- Conditions
- Nerve Block, Analgesia, Pectus Excavatum
- Being tested
- ESPB group, TPVB group
- Medical subject headings
- Agnosia, Funnel Chest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESPB groupProcedure or surgery
Also called Erector spinae plane block
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.
TPVB groupProcedure or surgery
Also called Thoracic paravertebral block
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.
| Study group | Role | What they receive |
|---|---|---|
| ESPB group | Experimental | 0.25% ropivacaine 0.5 ml/kg is injected at the fascial plane deep to the erector spinae muscle Receives: Procedure: ESPB group |
| TPVB group | Active comparator | 0.25% ropivacaine 0.5 ml/kg is injected into the thoracic paravertebral space (T5) using TPVB approach. Receives: Procedure: TPVB group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores at rest at 24 hours postoperatively
Pain scores will be recorded using the Numeric Rating Scale (NRS) scores (0-10).
Measured: 24 hours postoperatively
Secondary outcomes (7)
The pain degree at rest and after movement or coughing(dynamic)
The pain degree at rest and after movement or coughing at 3, 6, 12, 24, and 48 hours after surgery respectively.
Measured: at 3, 6, 12, 24, and 48 hours after surgery
total rescue morphine-equivalent consumption per weight
total rescue morphine-equivalent consumption per weight at predetermined time intervals (24 and 48 hours) after surgery
Measured: at 24 and 48 hours after surgery
Emergence agitation 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
Measured: at 5, 15, 30 min after extubation
Total dosage of intraoperative sufentanil and remifentanil
Total dosage of intraoperative sufentanil and remifentanil per weight
Measured: during surgery
The time to first analgesia request
Time from operation to first rescue analgesia request
Measured: within the 3 days after surgery
The time to first mobilization
Time from operation to ambulation
Measured: within the 3 days after surgery
Side effects
Side effects such as pneumothorax, local anesthetic toxicity, postoperative nausea and vomiting
Measured: within the 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start25 Sep 2021
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
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 Nerve BlockStudies of the same condition, open and under way.
- More trials run by West China 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Xu, West China Hospital
- Investigators
- Jin Liu, Study chair, Department of Anesthesiology, West China Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034601
- Sponsor's protocol ID
- 2021-866
- Status last verified
- Nov 2023
- First submitted
- 21 Aug 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu M, Zhang G, Gong J, Yang J. Comparison of erector spinae plane and paravertebral nerve blocks for postoperative analgesia in children after the Nuss procedure: study protocol for a randomized controlled non-inferiority clinical trial. Trials. 2022 Feb 14;23(1):139. doi: 10.1186/s13063-022-06044-y.
PubMed 35164831
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Erector Spinae Plane and Paravertebral Nerve Blocks for Postoperative Analgesia in Children After the Nuss Procedure
- ClinicalTrials.gov ID
- NCT05034601
- Acronym / sponsor ID
- 2021-866
- Conditions
- Nerve Block, Analgesia, Pectus Excavatum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 25 Sep 2021 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 5 Sep 2021 (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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB group | Experimental | Procedure: ESPB group0.25% ropivacaine 0.5 ml/kg is injected at the fascial plane deep to the erector spinae muscle |
| TPVB group | Active comparator | Procedure: TPVB group0.25% ropivacaine 0.5 ml/kg is injected into the thoracic paravertebral space (T5) using TPVB approach. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Age between 4 to 18 years Scheduled for elective Nuss surgery Written informed consent is obtained from parents of each patient.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| ESPB groupAlso: Erector spinae plane blockA 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. | Procedure or surgery | ESPB group |
| TPVB groupAlso: Thoracic paravertebral blockA 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. | Procedure or surgery | TPVB group |
Primary outcome
Pain scores at rest at 24 hours postoperatively
Time frame: 24 hours postoperatively
Pain scores will be recorded using the Numeric Rating Scale (NRS) scores (0-10).
7 secondary outcomes
The pain degree at rest and after movement or coughing(dynamic)
Time frame: at 3, 6, 12, 24, and 48 hours after surgery
total rescue morphine-equivalent consumption per weight
Time frame: at 24 and 48 hours after surgery
Emergence agitation at 5, 15, 30 min after extubation
Time frame: at 5, 15, 30 min after extubation
Total dosage of intraoperative sufentanil and remifentanil
Time frame: during surgery
The time to first analgesia request
Time frame: within the 3 days after surgery
The time to first mobilization
Time frame: within the 3 days after surgery
Side effects
Time frame: within the 5 days after surgery
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 18 Nov 2023.
- Derived from this study: PubMed 35164831Xu M, Zhang G, Gong J, Yang J. Comparison of erector spinae plane and paravertebral nerve blocks for postoperative analgesia in children after the Nuss procedure: study protocol for a randomized controlled non-inferiority clinical trial. Trials. 2022 Feb 14;23(1):139. doi: 10.1186/s13063-022-06044-y.
- Individual participant dataSharing planned: No
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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.
Jin Liu study chair
Department of Anesthesiology, West China Hospital, Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESPB group and TPVB group in people with Nerve Block and Analgesia, run by West China 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 1 inclusion and 1 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 18 Nov 2023. 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?
Pain scores at rest at 24 hours postoperatively (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 NCT05034601, 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 18 Nov 2023.