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Clinical Trials/NCT04217213
NCT04217213
Unknown
Not Applicable

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

Xuzhou Medical University1 site in 1 country124 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Xuzhou Medical University
Enrollment
124
Locations
1
Primary Endpoint
Incidence of chronic pain after chest surgery
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
November 30, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Xuzhou Medical University
Responsible Party
Principal Investigator
Principal Investigator

Han Yuan

associate chief physician

Xuzhou Medical University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Incidence of chronic pain after chest surgery

Time Frame: 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 Outcomes

  • Incidence of postoperative neuropathic pain(At the 3rd month after surgery)
  • Cost of stay(At the 3rd month after surgery)
  • icu length of stay(At the 3rd month after surgery)
  • Incidence of secondary operation(At the 3rd month after surgery)
  • Incidence of other postoperative complications(At the 3rd month after surgery)
  • The incidence of acute pain after chest surgery(24 to 72 hours after surgery)
  • Incidence of readmission within 30 days after surgery(At the 30 days after surgery)
  • Incidence of death within 30 days after surgery(At the 30 days after surgery)
  • Length of stay(At the 3rd month after surgery)

Study Sites (1)

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