NCT03916120

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

April 8, 2019

Last Update Submit

April 12, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative analgesic failure

    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.

Study Arms (2)

Postoperative Analgesic Failure

Genetic: Genetic analysis

Postoperative Analgesic Success

Genetic: Genetic analysis

Interventions

Collect 2ml intravenous blood from patients after anaesthesia.

Postoperative Analgesic FailurePostoperative Analgesic Success

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving single-port video-assisted thoracoscopic surgery.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

  • Xing X, Bai Y, Sun K, Yan M. Single nucleotide polymorphisms associated with postoperative inadequate analgesia after single-port VATS in Chinese population. BMC Anesthesiol. 2020 Feb 5;20(1):38. doi: 10.1186/s12871-020-0949-6.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Min Min, Doctor

    Zhejiang University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2019

First Posted

April 16, 2019

Study Start

July 15, 2018

Primary Completion

January 15, 2019

Study Completion

January 15, 2019

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations