- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07288424
Opioid-Free Pain Management After NUSS Surgery in Adolescents
Implementation and Efficacy of an Opioid-Free Analgesic Regimen for Postoperative Pain Management in Adolescent Patients With Pectus Excavatum After NUSS Surgery
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adolescents who underwent the NUSS procedure.
- Adolescents who were between 8 and 18 years .
Exclusion Criteria:
- Adolescents who received epidural analgesia.
- Adolescents who received bilateral paravertebral nerve blocks.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Experimental group
Patients who underwent ultrasound-guided bilateral transverse thoracic fascia block and intercostal nerve block after general anesthesia induction but before surgery.
|
Ultrasound-guided bilateral transverse thoracic fascia block and intercostal nerve block
|
|
Control group
Patients who received incision local infiltration, serratus anterior plane block, intercostal nerve block, and erector spinae plane block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
72 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: QIN Zhang, phd, Tongji Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJ-IRB202509077
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nerve Block
-
Lebanese American UniversityRecruitingImpedance | Axillary Nerve Block | Popliteal Sciatic Nerve Block | Interscalene Nerve Block | Ultrasound-Guided Nerve BlocksLebanon
-
Huazhong University of Science and TechnologyNot yet recruitingArthroscopic Shoulder Surgery | Suprascapular Nerve Block | Bupivacaine | Ultrasound Guided Nerve Block | Axillary Nerve Block
-
Diskapi Teaching and Research HospitalCompletedArthroscopic Shoulder Surgery | Suprascapular Nerve Block | Axillary Nerve BlockTurkey
-
Lawson Health Research InstituteUnknownInferior Alveolar Nerve Block | Greater Palatine Nerve BlockCanada
-
Armed Forces Institute of Dentistry, PakistanRecruitingInferior Alveolar Nerve Block | Success of Inferior Alveolar Nerve BlockPakistan
-
Tanta UniversityRecruitingArthroscopic Shoulder Surgery | Anterior Suprascapular Nerve Block | Interscalene Nerve BlockEgypt
-
Bozyaka Training and Research HospitalCompletedPeripheral Nerve Block | Foot and Ankle Surgery | Popliteal Nerve BlockTurkey
-
Ain Shams UniversityCompletedHip Hemiarthroplasty | Pericapsular Nerve Group Block | Lateral Femoral Cutaneous Nerve Block | Supra-inguinal Fascia Iliaca BlockEgypt
-
Ondokuz Mayıs UniversityCompletedAnesthesia, Local | Brachial Plexus Block | Nerve BlockTurkey
-
Kafrelsheikh UniversityRecruitingAnalgesia | Lateral Femoral Cutaneous Nerve Block | Vastus Lateralis Nerve Block | Knee SurgeriesEgypt
Clinical Trials on Nerve block
-
Helse Møre og Romsdal HFOslo University Hospital; St. Olavs Hospital; The Nordmøre and Romsdal Hospital...Not yet recruitingTotal Knee Arthroplasty | Osteoarthritis (OA) of the Knee | Genicular Nerve BlockNorway
-
CMC Ambroise ParéNot yet recruitingTotal Knee ArthroplastyFrance
-
LifeBridge HealthRubin Institute for Advanced OrthopedicsRecruitingHip Osteoarthritis | Hip ArthropathyUnited States
-
Chicago Anesthesia Pain SpecialistsCompletedKnee ArthroplastyUnited States
-
Benha UniversityNot yet recruitingPain, Postoperative
-
Severance HospitalRecruitingCough | Thoracic Surgery | Nerve BlockKorea, Republic of
-
Saint Francis CareCompleted
-
Servei Central d'AnestesiologiaInternational University of CataloniaNot yet recruitingPostoperative Pain | Regional Anesthesia MorbiditySpain
-
Servei Central d'AnestesiologiaNot yet recruitingPain, Postoperative | Maxillary Diseases | Adult Patients Undergoing Bimaxillary OsteotomySpain
-
Marmara UniversityNot yet recruitingHemidiaphragmatic Paralysis