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Single Nucleotide Polymorphisms (SNPs) Associated With Postoperative Analgesic Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916120
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
Postoperative pain remains relatively high within 48h for Chinese patients who receive video-assisted thoracoscopic surgery. Different patients experience different pain intensity. This suggests that there may be genetic variants that make some patients susceptible to analgesic failure. Using blood samples from patients, the investigators are going to analyze the relationship between single nucleotide polymorphisms (SNPs) in genes that are known to be involved in analgesic failure.

Condition or disease Intervention/treatment
Pain, Postoperative Thoracic Surgery, Video-Assisted Polymorphism, Single Nucleotide Genetic: Genetic analysis

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Study Type : Observational
Actual Enrollment : 198 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Single Nucleotide Polymorphisms (SNPs) Associated With Postoperative Analgesic Failure After Single-port Video-Assisted Thoracoscopic Surgery
Actual Study Start Date : July 15, 2018
Actual Primary Completion Date : January 15, 2019
Actual Study Completion Date : January 15, 2019

Group/Cohort Intervention/treatment
Postoperative Analgesic Failure Genetic: Genetic analysis
Collect 2ml intravenous blood from patients after anaesthesia.

Postoperative Analgesic Success Genetic: Genetic analysis
Collect 2ml intravenous blood from patients after anaesthesia.




Primary Outcome Measures :
  1. Postoperative analgesic failure [ Time Frame: 8 a.m. at the first day after surgery. ]

    Once patient experience at least one of the following situations:

    1. Bad patients sleep quality
    2. Require extra analgesic drug
    3. Low satisfaction with pain control
    4. Bolus times > 1 per hour



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving single-port video-assisted thoracoscopic surgery.
Criteria

Inclusion Criteria:

  • Age ≤ 70 and Age ≥18
  • Selective operation lung section with video-assisted thoracic surgery (VATS)
  • III ≥ American Society of Anesthesiologists classification (ASA classification) ≥I
  • Patients informed and agreed to join the study

Exclusion Criteria:

  • Abnormal function of liver and kidney
  • Allergic- dependence history of alcohol, opioids and Local anesthetics
  • No noncompliance
  • Mental disease history,language communication disorder,cicatricial diathesis
  • Underweight or overweight(BMI<18 or >30)
  • Patients not suitable for clinical subjects for other reasons
  • Sedatives, analgesics, antiemetic drugs and anti pruritus drugs were used within 24hours before the operation.
  • History of previous abnormal anaesthesia
  • Women during pregnancy or lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916120


Locations
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China, Zhejiang
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Study Chair: Min Min, Doctor Zhejiang University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03916120    
Other Study ID Numbers: 2018-067
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations