AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in China

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 groups in NCT07288424
Study groupRoleWhat they receive
Experimental groupPatients 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 groupPatients 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.

  1. 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.

  1. First posted17 Dec 2025
  2. Study start1 Jun 2025
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in