Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery

NCT ID: NCT04217213

Last Updated: 2020-01-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2020-11-30

Brief Summary

This project intends to investigate the effects of intercostal nerve block with ropivacaine combined with mecobalamin on chronic post-surgical pain (CPSP) in thoracic postoperative patients. Related clinical characteristics of postoperative chronic pain. The results of the study provide clinicians with a simple and inexpensive new method of preventing CPSP, in order to prevent the occurrence of CPSP and reduce the incidence of CPSP, thereby reducing CPSP to patients and their families, hospitals. And public resources.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

ropivacaine combined with mecobalamine

Intercostal nerve block with 0.5% ropivacaine combined with mecobalamine (0.5mg).

Group Type: EXPERIMENTAL

Intercostal nerve block

Intervention Type: PROCEDURE

In the experimental group, the surgeons used 0.5% ropivacaine combined with mecobalamine (0.5mg) before the operation to perform intercostal nerve block in the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity, and injected 5ml in each intercostal nerve block.In the control group, surgeons used 0.5% ropivacaine alone before the operation to perform intercostal nerve block through the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity. 5ml was injected into each intercostal nerve block.

ropivacaine

Intercostal nerve block with 0.5% ropivacaine alone.

Group Type: ACTIVE_COMPARATOR

Intercostal nerve block

Intervention Type: PROCEDURE

In the experimental group, the surgeons used 0.5% ropivacaine combined with mecobalamine (0.5mg) before the operation to perform intercostal nerve block in the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity, and injected 5ml in each intercostal nerve block.In the control group, surgeons used 0.5% ropivacaine alone before the operation to perform intercostal nerve block through the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity. 5ml was injected into each intercostal nerve block.

Interventions

Intercostal nerve block

In the experimental group, the surgeons used 0.5% ropivacaine combined with mecobalamine (0.5mg) before the operation to perform intercostal nerve block in the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity, and injected 5ml in each intercostal nerve block.In the control group, surgeons used 0.5% ropivacaine alone before the operation to perform intercostal nerve block through the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity. 5ml was injected into each intercostal nerve block.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years old, conscious;

2. ASA class Ⅰ ~ Ⅲ;

3. Thoracoscopic lobectomy was proposed;

4. The han nationality;

5. Native speaker of Chinese;

6. Agree to participate in this study and sign the informed consent.

Exclusion Criteria

1. Patients allergic to meccobalamin or ropivacaine;

2. Patients with previous history of chest surgery;

3. Patients with tumor invasion of chest wall, abscess, tumor intercostal neuropathy or pathological rib fracture;

4. Patients with a history of analgesic addiction or abuse, epilepsy, one or other neurological disease;

5. Diabetic patients;

6. Patients who need other drugs for pain relief but have not completed treatment or have completed treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Han Yuan

associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Countries

China

Other Identifiers

XYFY2019-KL169-01

Identifier Type: -

Identifier Source: org_study_id