N/A
N=48
Comparative Study of Nonintubated Uniport Thoracoscopic Surgery Using Thoracic Paravertebral Nerve Block Versus Intercostal Nerve Block for Peripheral Solitary Pulmonary Nodule Patients
Peripheral Solitary Pulmonary Nodule or Tuberculoma
Bottom Line
View on ClinicalTrials.gov: NCT03086213 ↗Enrolled (actual)
48
Serious AEs
6.3%
Results posted
May 2020
Primary outcome: Primary: Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group — 33; 35; 39; 42 pg/L — p=0.025
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Propofol (Drug); Sulfentanyl (Drug); Dexmedetomidine (Drug); Lidocaine (Drug); Ropivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shenzhen Third People's Hospital
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group |
33; 35; 39; 42; 44; 53 | 0.025 sig |
| PRIMARY Concentration of Cortisol at Different Point During the Operation |
120; 125; 208; 221; 258; 290 | <0.05 sig |
| SECONDARY Comparing the Hemodynamics of the Intervention of the Each Group During the Operation |
78; 79; 84; 85; 81; 92 | — |
| SECONDARY Comparing the Hemodynamics of the Intervention of the Each Group During the Operation |
78; 79; 84; 85; 81; 92 | — |
| SECONDARY Comparing the Blood Gas Analysis After the Intervention of the Each Group |
95.2; 96.2; 51.1; 47.3 | 0.05 |
| SECONDARY Number of Participants With Puncture Related Complications |
2; 3; 2; 2 | — |
Summary
The aim of this study is to study the safety and effectiveness of the effects on the perioperative pain control comparing between the thoracic paravertebral nerve block using the camera guided and the intrathoracic intercostals nerve block for the management of nonintubated local regional analgesia in uniport thoracoscopic surgery for the undetermined solitary nodules patients.
Eligibility Criteria
Inclusion Criteria
- written informed consent
- the undetermined peripheral solitary pulmonary nodule or tuberculoma was enrolled
- the well cardiopulmonary function
- age between 18 and 65 years old
- less airway secretion
- body mass index less than 25
- I to II grade of the American Society of Anesthesiologists
- no metabolic diseases
Exclusion Criteria
- refusal or inability to comply with the informed consent
- the nodule of the nature of the non small cell lung caner is excluded
- hypovolemia, blood disorders or abnormal clotting mechanism
- the abnormal cardiopulmonary function(the American Society of Anesthesiologists greater than 3)
- lower airway infection,more than airway secretion
- abnormal anatomy of the spine, the history of thoracic back surgery
- impaired lung function(forced expiratory volume in second 1 less than predicted), or asthma uncontrolled on medications
- constrained cardiac output such as hypertrophic cardiomyopathy, mitral stenosis or complete atrioventricular block
- extensive pleural adhesion
- overweight (body mass index no less than 25)
- difficulty airway
- chronic pain score more than 5 before the surgery
- the history of bilateral thoracotomy
Data sourced from ClinicalTrials.gov (NCT03086213). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.