Nerve BlockNCT07288424
Opioid-Free Pain Management After NUSS Surgery in Adolescents
An observational study of Nerve Block, run by Qin Zhang at 1 site in China.
Trial summary
The investigators applied ultrasound-guided bilateral transverse thoracic fascia block combined with intercostal nerve block-a previously unreported analgesic approach for post-thoracic surgery-to NUSS patients. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Nerve Block
- What is being tested?
- Nerve block
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 30 Sep 2025
- Phase
- Observational
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study enrolled children and adolescents who underwent the NUSS procedure for pectus excavatum at the Department of Thoracic Surgery, Tongji Hospital, from June to September 2025. The inclusion criterion was age between 8 and 18 years.
Who may be able to join
- Adolescents who underwent the NUSS procedure.
- Adolescents who were between 8 and 18 years .
Who cannot join
- Adolescents who received epidural analgesia.
- Adolescents who received bilateral paravertebral nerve blocks.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Implementation and Efficacy of an Opioid-Free Analgesic Regimen for Postoperative Pain Management in Adolescent Patients With Pectus Excavatum After NUSS Surgery
The investigators applied ultrasound-guided bilateral transverse thoracic fascia block combined with intercostal nerve block-a previously unreported analgesic approach for post-thoracic surgery-to NUSS patients. These suggest that ultrasound-guided transverse thoracic fascia combined with intercostal nerve block, in conjunction with bupivacaine liposome (72-hour analgesic duration), holds promise for a clinically feasible opioid-free analgesic regimen for severe post-NUSS pain.
Read the detailed description
Performance of Nerve Blocks and Data collection Transverse thoracic fascia block: Under ultrasound guidance, the deep layer of the transverse thoracic fascia was localized at the parasternal 4th-5th intercostal space, with 10 mL of local anesthetic mixture (bupivacaine liposome 4mg/kg + 0.75% bupivacaine injection 5mL, diluted to 32mL with normal saline) injected on each side.
Intercostal nerve block: The 4th-8th intercostal spaces were identified at the posterior axillary line level. Under ultrasound guidance, the local anesthetic was injected between the internal intercostal and innermost intercostal muscles, with 2 mL of the aforementioned mixture administered per intercostal space.
Multimodal Analgesia Regimen
First, 50 mg of flurbiprofen axetil injection was intravenously administered before the surgeon made the skin incision. Second, 0.07 mg/kg of oxycodone was intravenously injected 30 minutes before the end of surgery. Third, a patient-controlled intravenous analgesia (PCA) pump was connected upon admission to the Post-Anesthesia Care Unit (PACU). After transfer to the ward, if the patient's pain score was ≥ 4 points, ward doctors administered diclofenac sodium via anal suppository.
Pain Assessment and Management Measures
Pain was assessed every 2 hours within 12 hours postoperatively (upon admission to the PACU, 2 hours, 4 hours, 6 hours, and 12 hours postoperatively) and every 4 hours from 12 to 72 hours postoperatively. Pain scores were recorded at each time point using a Visual Analogue Scale (VAS). Additionally, the time and dose of supplementary analgesics administered were documented, and pain relief efficacy was reassessed and recorded 2 hours after administration.
Study Population
This study enrolled children and adolescents who underwent the NUSS procedure for pectus excavatum at the Department of Thoracic Surgery, Tongji Hospital, from June to September 2025. The inclusion criterion was age between 8 and 18 years (inclusive). Patients who received epidural analgesia or bilateral paravertebral nerve blocks were excluded.
Experimental group: Patients who underwent ultrasound-guided bilateral transverse thoracic fascia block and intercostal nerve block after general anesthesia induction but before surgery.
Control group: Patients who received incision local infiltration, serratus anterior plane block, intercostal nerve block, and erector spinae plane block.
Study Variables The investigators collected relevant variables based on the quality of postoperative recovery in NUSS patients reported in the literature. Data Collection and Measurement of Variables: Demographic data of patients were collected upon hospital admission. Pain was assessed using a Visual Analogue Scale (VAS).Time and dose of additional postoperative analgesic drugs; Postoperative recovery indicators: breathing pain, compulsive posture, postoperative hospital stay, oxygen inhalation rate exceeding 24 hours after operation.
Statistical Analysis R studio was used for statistical analysis in this study. Categorical data were expressed as counts (percentages) [n(%)], and comparisons between groups were performed using the chi-square test; if the theoretical frequency was <5, Fisher's exact test was applied. Normality test was first performed for continuous data. Continuous data conforming to normal distribution were presented as mean ± standard deviation (x±s), and independent samples t-test was used for intergroup comparisons, while repeated measures analysis of variance (ANOVA) was used for intragroup comparisons at different time points. Continuous data not conforming to normal distribution were expressed as median (interquartile range) [M(Q1,Q3)], and intergroup comparisons were conducted using the Mann-Whitney U test. A P value <0.05 was considered statistically significant.
- Conditions
- Nerve Block
- Being tested
- Nerve block
- Keywords
- Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve blockProcedure or surgery
Ultrasound-guided bilateral transverse thoracic fascia block and intercostal nerve block
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Patients who underwent ultrasound-guided bilateral transverse thoracic fascia block and intercostal nerve block after general anesthesia induction but before surgery. Receives: Procedure: Nerve block | |
| Control group | Patients who received incision local infiltration, serratus anterior plane block, intercostal nerve block, and erector spinae plane block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain was assessed every 2 hours within 12 hours postoperatively (upon admission to the PACU, 2 hours, 4 hours, 6 hours, and 12 hours postoperatively) and every 4 hours from 12 to 72 hours postoperatively. Pain scores were recorded at each time point using a Visual Analogue Scale (VAS).
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 Jun 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qin Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qin Zhang, Tongji Hospital
- Investigators
- Qin Zhang, phd, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288424
- Sponsor's protocol ID
- TJ-IRB202509077
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Efficacy of an Opioid-Free Analgesic Regimen for Postoperative Pain Management in Adolescent Patients With Pectus Excavatum After NUSS Surgery
- ClinicalTrials.gov ID
- NCT07288424
- Acronym / sponsor ID
- TJ-IRB202509077
- Conditions
- Nerve Block
- Keywords
- Nerve Block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Qin ZhangUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 17 Dec 2025 (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.
The investigators applied ultrasound-guided bilateral transverse thoracic fascia block combined with intercostal nerve block-a previously unreported analgesic approach for post-thoracic surgery-to NUSS patients. These suggest that ultrasound-guided transverse thoracic fascia combined with intercostal nerve block, in conjunction with bupivacaine liposome (72-hour analgesic duration), holds promise for a clinically feasible opioid-free analgesic regimen for severe post-NUSS pain.
Detailed description
Performance of Nerve Blocks and Data collection Transverse thoracic fascia block: Under ultrasound guidance, the deep layer of the transverse thoracic fascia was localized at the parasternal 4th-5th intercostal space, with 10 mL of local anesthetic mixture (bupivacaine liposome 4mg/kg + 0.75% bupivacaine injection 5mL, diluted to 32mL with normal saline) injected on each side.
Intercostal nerve block: The 4th-8th intercostal spaces were identified at the posterior axillary line level. Under ultrasound guidance, the local anesthetic was injected between the internal intercostal and innermost intercostal muscles, with 2 mL of the aforementioned mixture administered per intercostal space.
Multimodal Analgesia Regimen
First, 50 mg of flurbiprofen axetil injection was intravenously administered before the surgeon made the skin incision. Second, 0.07 mg/kg of oxycodone was intravenously injected 30 minutes before the end of surgery. Third, a patient-controlled intravenous analgesia (PCA) pump was connected upon admission to the Post-Anesthesia Care Unit (PACU). After transfer to the ward, if the patient's pain score was ≥ 4 points, ward doctors administered diclofenac sodium via anal suppository.
Pain Assessment and Management Measures
Pain was assessed every 2 hours within 12 hours postoperatively (upon admission to the PACU, 2 hours, 4 hours, 6 hours, and 12 hours postoperatively) and every 4 hours from 12 to 72 hours postoperatively. Pain scores were recorded at each time point using a Visual Analogue Scale (VAS). Additionally, the time and dose of supplementary analgesics administered were documented, and pain relief efficacy was reassessed and recorded 2 hours after administration.
Study Population
This study enrolled children and adolescents who underwent the NUSS procedure for pectus excavatum at the Department of Thoracic Surgery, Tongji Hospital, from June to September 2025. The inclusion criterion was age between 8 and 18 years (inclusive). Patients who received epidural analgesia or bilateral paravertebral nerve blocks were excluded.
Experimental group: Patients who underwent ultrasound-guided bilateral transverse thoracic fascia block and intercostal nerve block after general anesthesia induction but before surgery.
Control group: Patients who received incision local infiltration, serratus anterior plane block, intercostal nerve block, and erector spinae plane block.
Study Variables The investigators collected relevant variables based on the quality of postoperative recovery in NUSS patients reported in the literature. Data Collection and Measurement of Variables: Demographic data of patients were collected upon hospital admission. Pain was assessed using a Visual Analogue Scale (VAS).Time and dose of additional postoperative analgesic drugs; Postoperative recovery indicators: breathing pain, compulsive posture, postoperative hospital stay, oxygen inhalation rate exceeding 24 hours after operation.
Statistical Analysis R studio was used for statistical analysis in this study. Categorical data were expressed as counts (percentages) [n(%)], and comparisons between groups were performed using the chi-square test; if the theoretical frequency was <5, Fisher's exact test was applied. Normality test was first performed for continuous data. Continuous data conforming to normal distribution were presented as mean ± standard deviation (x±s), and independent samples t-test was used for intergroup comparisons, while repeated measures analysis of variance (ANOVA) was used for intragroup comparisons at different time points. Continuous data not conforming to normal distribution were expressed as median (interquartile range) [M(Q1,Q3)], and intergroup comparisons were conducted using the Mann-Whitney U test. A P value <0.05 was considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Procedure: Nerve blockPatients who underwent ultrasound-guided bilateral transverse thoracic fascia block and intercostal nerve block after general anesthesia induction but before surgery. |
| Control group | – | –Patients who received incision local infiltration, serratus anterior plane block, intercostal nerve block, and erector spinae plane block. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study enrolled children and adolescents who underwent the NUSS procedure for pectus excavatum at the Department of Thoracic Surgery, Tongji Hospital, from June to September 2025. The inclusion criterion was age between 8 and 18 years.
Key inclusion criteria (2 listed)
- Adolescents who underwent the NUSS procedure.
- Adolescents who were between 8 and 18 years .
Key exclusion criteria (2 listed)
- Adolescents who received epidural analgesia.
- Adolescents who received bilateral paravertebral nerve blocks.
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 |
|---|---|---|
| Nerve blockUltrasound-guided bilateral transverse thoracic fascia block and intercostal nerve block | Procedure or surgery | Experimental group |
Primary outcome
Pain score
Time frame: 72 hours
Pain was assessed every 2 hours within 12 hours postoperatively (upon admission to the PACU, 2 hours, 4 hours, 6 hours, and 12 hours postoperatively) and every 4 hours from 12 to 72 hours postoperatively. Pain scores were recorded at each time point using a Visual Analogue Scale (VAS).
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 17 Dec 2025.
- 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.
Qin Zhang, phd principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nerve Block, run by Qin Zhang 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 2 inclusion and 2 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 17 Dec 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?
Pain score (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2025.