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

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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Intercostal nerve block

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 225000
      • Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ropivacaine combined with mecobalamine; Intercostal nerve block with 0.5% ropivacaine combined with mecobalamine (0.5mg).	Procedure: 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.
Active Comparator: ropivacaine; Intercostal nerve block with 0.5% ropivacaine alone.	Procedure: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xuzhou Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: November 30, 2019
• First Submitted That Met QC Criteria: January 1, 2020
• First Posted (Actual): January 3, 2020

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: January 1, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: XYFY2019-KL169-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No