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

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ClinicalTrials.gov Identifier: NCT04217213
Recruitment Status : Not yet recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Han Yuan, Xuzhou Medical University

Tracking Information
First Submitted Date  ICMJE November 30, 2019
First Posted Date  ICMJE January 3, 2020
Last Update Posted Date January 3, 2020
Estimated Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 1, 2020)
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".
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 1, 2020)
  • The incidence of acute pain after chest surgery [ Time Frame: 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 postoperative neuropathic pain [ Time Frame: 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".
  • Incidence of other postoperative complications [ Time Frame: 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.
  • Incidence of readmission within 30 days after surgery [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At the 3rd month after surgery ]
    The total length of hospital stay.
  • Cost of stay [ Time Frame: At the 3rd month after surgery ]
    The total cost of hospital stay.
  • icu length of stay [ Time Frame: At the 3rd month after surgery ]
    The number of hours of postoperative stay in ICU.
  • Incidence of secondary operation [ Time Frame: At the 3rd month after surgery ]
    Whether the patient has a second operation and the reason and the incidence of this operation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery
Official Title  ICMJE Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery -- a Single-center Randomized, Double-blind Controlled Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Postoperative Pain
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: ropivacaine combined with mecobalamine
    Intercostal nerve block with 0.5% ropivacaine combined with mecobalamine (0.5mg).
    Intervention: Procedure: Intercostal nerve block
  • Active Comparator: ropivacaine
    Intercostal nerve block with 0.5% ropivacaine alone.
    Intervention: Procedure: Intercostal nerve block
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 1, 2020)
124
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04217213
Other Study ID Numbers  ICMJE XYFY2019-KL169-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Han Yuan, Xuzhou Medical University
Study Sponsor  ICMJE Xuzhou Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Xuzhou Medical University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP