Single Nucleotide Polymorphisms (SNPs) Associated With Postoperative Analgesic Failure

April 12, 2019 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Single Nucleotide Polymorphisms (SNPs) Associated With Postoperative Analgesic Failure After Single-port Video-Assisted Thoracoscopic Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • The Second Affiliated Hospital of Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients receiving single-port video-assisted thoracoscopic surgery.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 a.m. at the first day after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Chair: Min Min, Doctor, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2018

Primary Completion (Actual)

January 15, 2019

Study Completion (Actual)

January 15, 2019

Study Registration Dates

First Submitted

April 8, 2019

First Submitted That Met QC Criteria

April 12, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 12, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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