Pain, PostoperativeNCT03916120
Single Nucleotide Polymorphisms (SNPs) Associated With Postoperative Analgesic Failure
An observational study of Pain, Postoperative and Thoracic Surgery, Video-Assisted, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Postoperative, Thoracic Surgery, Video-Assisted, Polymorphism, Single Nucleotide
- What is being tested?
- Genetic analysis
- Type of treatment
- Injection or infusion
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2018to 15 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving single-port video-assisted thoracoscopic surgery.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: 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.
- Being tested
- Genetic analysis
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic analysisGenetic
Collect 2ml intravenous blood from patients after anaesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative Analgesic Failure | Not described Receives: Genetic: Genetic analysis | |
| Postoperative Analgesic Success | Not described Receives: Genetic: Genetic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesic failure
Once patient experience at least one of the following situations:
- Bad patients sleep quality
- Require extra analgesic drug
- Low satisfaction with pain control
- Bolus times > 1 per hour
Measured: 8 a.m. at the first day after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start15 Jul 2018
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Min, Doctor, Study chair, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916120
- Sponsor's protocol ID
- 2018-067
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32024468
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Nucleotide Polymorphisms (SNPs) Associated With Postoperative Analgesic Failure After Single-port Video-Assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT03916120
- Acronym / sponsor ID
- 2018-067
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postoperative Analgesic Failure | – | Genetic: Genetic analysis |
| Postoperative Analgesic Success | – | Genetic: Genetic analysis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving single-port video-assisted thoracoscopic surgery.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic analysisCollect 2ml intravenous blood from patients after anaesthesia. | Genetic | Postoperative Analgesic Failure, Postoperative Analgesic Success |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Derived from this study: PubMed 32024468Xing 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.
- Individual participant dataSharing planned: Undecided
Related trials for Pain, Postoperative
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Min, Doctor study chair
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Thoracic Surgery, Video-Assisted, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesic failure (time frame: 8 a.m. at the first day after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03916120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.