Comparative Study of Nonintubated Uniport Thoracoscopic Surgery Using Thoracic Paravertebral Nerve Block Versus Intercostal Nerve Block for Peripheral Solitary Pulmonary Nodule Patients

NCT03086213 | Completed Results DMC

• 1 other identifier: 19800911
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Solitary Pulmonary Nodule or Tuberculoma

Keywords

nonintubated uniport thoracoscopic surgery; paravertebral nerve block; intercostal nerve block; peripheral solitary pulmonary nodule

Outcome Measures

Primary Outcomes (2)

• Comparing the Inflammatory Markers During the Operation After the Intervention of the Each Group

  serum concentrations of Interleukin-6

  During the operation, an average of one hour

• Concentration of Cortisol at Different Point During the Operation

  During the operation, an average of one hour

Secondary Outcomes (4)

• Comparing the Hemodynamics of the Intervention of the Each Group During the Operation

  During the operation, an average of one hour

• Comparing the Hemodynamics of the Intervention of the Each Group During the Operation

  During the operation, an average of one hour

• Comparing the Blood Gas Analysis After the Intervention of the Each Group

  During the operation, an average of one hour

• Number of Participants With Puncture Related Complications

  7 days

Study Arms (2)

paravertebral nerve block group

EXPERIMENTAL

non-intubated thoracic paravertebral nerve block of regional anesthesia Thoracic paravertebral nerve block of regional anesthesia at the T4 thoracic interspace

Drug: Propofol; Drug: Sulfentanyl; Drug: Dexmedetomidine; Drug: Lidocaine; Drug: Ropivacaine

intercostals nerve block group

ACTIVE COMPARATOR

non-intubated intercostal nerve block of regional anesthesia Thoracic intercostal nerve block of regional anesthesia at the T3/4/5 thoracic interspace

Drug: Propofol; Drug: Sulfentanyl; Drug: Dexmedetomidine; Drug: Lidocaine; Drug: Ropivacaine

Interventions

Propofol DRUG

anaesthetic

intercostals nerve block group; paravertebral nerve block group

Sulfentanyl DRUG

anaesthetic

intercostals nerve block group; paravertebral nerve block group

Dexmedetomidine DRUG

anaesthetic

intercostals nerve block group; paravertebral nerve block group

Lidocaine DRUG

local anaesthetics

intercostals nerve block group; paravertebral nerve block group

Ropivacaine DRUG

local anaesthetics

intercostals nerve block group; paravertebral nerve block group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenzhen Third People's Hospital: lead

Study Sites (1)

the Third People's Hospital of Shenzhen

Shenzhen, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Tuberculoma

Interventions

Propofol; Sufentanil; Dexmedetomidine; Lidocaine; Ropivacaine

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Thoracic surgical department
• Organization: Shenzhen Third People,s Hospital

daoren_000113@126.com

13823135410

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of thoracic surgical department, Principal investigator, Associate clinical professor

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 22, 2017
• Study Start: March 1, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 5, 2019
• Last Updated: May 7, 2020
• Results First Posted: May 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)