Application of Ultrasound-Guided Thoracic Paravertebral Block in Pulmonary Ablation Surgery

NCT ID: NCT05437718

Last Updated: 2022-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-06-01

Brief Summary

Local thermal ablation therapy of tumor is a rapidly developing minimally invasive therapy for lung tumors in recent years. This study evaluated the efficacy of thoracic paravertebral block (TPVB) for anaesthesia during ablation surgery of lung tumor.

Detailed Description

Lung cancer is a serious threat to human health and life. Local thermal ablation therapy of tumor is the focus of domestic and overseas research in the past decade.Thoracic paravertebral nerve block (TPVB) is the technique of injecting local anaesthetic in the paravertebral space to anesthetizes the spinal nerve roots and sympathetic chain，which will produces ipsilateral and somatic blockade.The present study was designed to evaluate the analgesic effect and safety of TPVB in the ablation surgery of lung tumor.

After obtaining approval from the Hospital Ethics Committee and informed written consent from the patients,30 adult patients scheduled for Local thermal ablation therapy of lung tumours were recruited. Patients were excluded if they had a history of psychiatric illness, chronic pain, regular analgesic usage or there were contraindications to performing a TPVB, such as chest wall deformity, severe coagulopathy, local infection and allergy to local anaesthetic drugs. The study lasted a total of six months.

During the preoperative visit, all patients received the explanation of overall research approach.After entering the CT fluoroscopy room, peripheral veins and routine monitoring that included electrocardiography, pulse oximetry, and noninvasive arterial blood pressure were obtained in all patients.Thoracic paravertebral block was performed 20 minutes before the Local thermal ablation therapy began.The degree of pain was assessed using VAS score; at performing TPVB，the beginning of surgery， 6 and 24 hours after ablation surgery.Dezocine will be given as remedial analgesia.Following the operation, transferred the patients to the observation area where the vital signs were monitored for 30 min.Assessing and record the degree of patients and surgeons satisfaction for anesthetic management.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Group NB (thoracic paravertebral block Group)

Thoracic paravertebral block(TPVB) is performed 20 minutes before the ablation surgery began,30 mL of 0.375% ropivacaine was totally injected in T3-4 and T5-6 spinal segment（the block segment can be adjusted according to the tumor site) under the ultrasound guidance.

Group Type: OTHER

Ropivacaine

Intervention Type: OTHER

Thoracic paravertebral block(TPVB) is performed on the patients who undergo the thermal ablation therapy.

Interventions

Ropivacaine

Thoracic paravertebral block(TPVB) is performed on the patients who undergo the thermal ablation therapy.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients diagnosed with lung cancer by imaging examination

2. Informed consent of the patient and study approval by the Medical Ethics Committee

Exclusion Criteria

1. have a history of psychiatric illness, chronic pain, regular analgesic usage

2. have contraindications to performing a TPVB, such as chest wall deformity, severe coagulopathy, local infection

3. have allergy to local anaesthetic drugs

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Affiliated Hospital of Nantong University

OTHER

Sponsor Role: lead

Responsible Party

Yuan Zhou

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yuan Zhou, Doctor

Role: STUDY_DIRECTOR

Affiliated Hospital of Nantong University

Locations

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Countries

China

Other Identifiers

2021-K145

Identifier Type: -

Identifier Source: org_study_id