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

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery -- a Single-center Randomized, Double-blind Controlled Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Intercostal nerve block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old, conscious; ASA class Ⅰ   Ⅲ; Thoracoscopic lobectomy was proposed; The han nationality; Native speaker of Chinese; Agree to participate in this study and sign the informed consent. Exclusion Criteria: Patients allergic to meccobalamin or ropivacaine; Patients with previous history of chest surgery; Patients with tumor invasion of chest wall, abscess, tumor intercostal neuropathy or pathological rib fracture; Patients with a history of analgesic addiction or abuse, epilepsy, one or other neurological disease; Diabetic patients; Patients who need other drugs for pain relief but have not completed treatment or have completed treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ropivacaine combined with mecobalamine<br>Intercostal nerve block with 0.5% ropivacaine combined with mecobalamine (0.5mg). | Procedure: Intercostal nerve block<br>* 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.<br>|
| Active Comparator: ropivacaine<br>Intercostal nerve block with 0.5% ropivacaine alone. | Procedure: Intercostal nerve block<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of chronic pain after chest surgery | The incidence of chronic pain after chest surgery was measured by NRS(numeric rating scales) at the 3rd month after surgery.For pain evaluation,we used the 11 point numeric rating scale(NRS),where an NRS scores of 0 represented no pain and a score of 10 represented worst pain imaginable. | At the 3rd month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of acute pain after chest surgery | An NRS score was performed 24 to 72 hours after surgery to determine the incidence of acute pain after thoracic surgery.For pain evaluation,we used the 11 point numeric rating scale(NRS),where an NRS scores of 0 represented no pain and a score of 10 represented worst pain imaginable. | 24 to 72 hours after surgery | 
| Incidence of postoperative neuropathic pain | The incidence of neuropathic pain was measured by DN4 scale at the 3rd month after surgery.Douleur Neuropathique 4 (DN4) is a screening questionnaire to help identify neuropathic pain (NP) in clinical practice and research,where a DN4 scores greater than or equal to 4 represented the patients had postoperative neuropathic pain. | At the 3rd month after surgery | 
| Incidence of other postoperative complications | Postoperative complications included that pulmonary complications, delirium, intestinal obstruction, pulmonary embolism, acute respiratory failure, acute renal failure, incision infection, cerebrovascular accident and other complications related to surgery. | At the 3rd month after surgery | 
| Incidence of readmission within 30 days after surgery | The incidence and the reason of readmission within 30 days after surgery was obtained through postoperative follow-up. | At the 30 days after surgery | 
| Incidence of death within 30 days after surgery | The incidence and the reason of death within 30 days after surgery was obtained through postoperative follow-up | At the 30 days after surgery | 
| Length of stay | The total length of hospital stay. | At the 3rd month after surgery | 
| Cost of stay | The total cost of hospital stay. | At the 3rd month after surgery | 
| icu length of stay | The number of hours of postoperative stay in ICU. | At the 3rd month after surgery | 
| Incidence of secondary operation | Whether the patient has a second operation and the reason and the incidence of this operation. | At the 3rd month after surgery |