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

Not Applicable

• Conditions: Postoperative Pain
• Interventions: Procedure: Intercostal nerve block

• Registration Number: NCT04217213
• Lead Sponsor: Xuzhou Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-30
• Status Verified: 2020-01
• Study Start: 2020-01-01
• Study First Submitted QC: 2020-01-01
• Last Update Submitted: 2020-01-01
• Study First Posted: 2020-01-03
• Last Update Posted: 2020-01-03
• Primary Completion: 2020-06-30
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ropivacaine combined with mecobalamine	Intercostal nerve block	Intercostal nerve block with 0.5% ropivacaine combined with mecobalamine (0.5mg).
ropivacaine	Intercostal nerve block	Intercostal nerve block with 0.5% ropivacaine alone.

Primary Outcome Measures

Name	Time	Method
Incidence of chronic pain after chest surgery	At the 3rd month after 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".

Secondary Outcome Measures

Name	Time	Method
Incidence of postoperative neuropathic pain	At the 3rd month after surgery	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".
Cost of stay	At the 3rd month after surgery	The total cost of hospital stay.
icu length of stay	At the 3rd month after surgery	The number of hours of postoperative stay in ICU.
Incidence of secondary operation	At the 3rd month after surgery	Whether the patient has a second operation and the reason and the incidence of this operation.
Incidence of other postoperative complications	At the 3rd month after surgery	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.
The incidence of acute pain after chest surgery	24 to 72 hours after 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".
Incidence of readmission within 30 days after surgery	At the 30 days after surgery	The incidence and the reason of readmission within 30 days after surgery was obtained through postoperative follow-up.
Incidence of death within 30 days after surgery	At the 30 days after surgery	The incidence and the reason of death within 30 days after surgery was obtained through postoperative follow-up
Length of stay	At the 3rd month after surgery	The total length of hospital stay.

Trial Locations

Locations (1)

Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China