Pain, PostoperativeNCT00824772
Evaluation of Pharmacogenetic Factors Affecting Fentanyl Requirements for Postoperative Pain Control
An observational study of Pain, Postoperative, run by Inje University at 1 site in South Korea.
Trial summary
Fentanyl is a widely used opioid analgesic. There are big interindividual variabilities in dose requirements of fentanyl for postoperative pain control. This study aims to reveal the genetic factors affecting the variable requirements of fentanyl during postoperative period. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women only
- Conditions the study is for
- Pain, Postoperative
- How many people
- 204 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2008to Dec 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Gynecologic patients undergoing total abdominal hysterectomy or laparoscpy assisted vaginal hysterectomy under general anesthesia
Who may be able to join
- Patients undergoing total abdominal hysterectomy (TAH) or laparoscopy assisted vaginal hysterectomy (LAVH) under general anesthesia
- Patients who want to use intravenous patient controlled analgesia (PCA) after surgery
- ASA physical status class I, II
Who cannot join
- history of drug addiction
- opioid medication within 12 hours before surgery
- previous history of opioid medication for 3 months
- neurologic disorder
- cardiac disorder
- hepatic disease
Show all 11Show fewer
- renal disease
- respiratory disease such as COPD, asthma
- sleep apnea
- BMI > 30
- psycotic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pharmacogenetic Factors Contributing to Dose Requirement of Fentanyl for Postoperative Pain Control: Genetic Polymorphisms of OPRM1, ABCB1, CYP3A4 and CYP3A5
Fentanyl is a widely used opioid analgesic. There are big interindividual variabilities in dose requirements of fentanyl for postoperative pain control. This study aims to reveal the genetic factors affecting the variable requirements of fentanyl during postoperative period.
Read the detailed description
The candidate genes are OPRM1, ABCB1,CYP3A4 and CYP3A5.
- Conditions
- Pain, Postoperative
- Keywords
- pharmacogenetics
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Cumulative Fentanyl Consumption
Measured: 24 hr after surgery
Secondary outcomes (1)
Postoperative Cumulative Fentanyl Consumption
Measured: 48hr after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startSep 2008
- Primary completionDec 2010
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kye-Min Kim, Inje University
- Investigators
- Kye-Min Kim, MD. PhD., Principal investigator, Department of Anesthesia, Inje University Sanggye Paik Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824772
- Sponsor's protocol ID
- 00012007317-00
- Status last verified
- May 2013
- First submitted
- 16 Jan 2009
- Last updated
- 4 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kim KM, Kim HS, Lim SH, Cheong SH, Choi EJ, Kang H, Choi HR, Jeon JW, Yon JH, Oh M, Shin JG. Effects of genetic polymorphisms of OPRM1, ABCB1, CYP3A4/5 on postoperative fentanyl consumption in Korean gynecologic patients. Int J Clin Pharmacol Ther. 2013 May;51(5):383-92. doi: 10.5414/CP201824.
PubMed 23557865
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pharmacogenetic Factors Contributing to Dose Requirement of Fentanyl for Postoperative Pain Control: Genetic Polymorphisms of OPRM1, ABCB1, CYP3A4 and CYP3A5
- ClinicalTrials.gov ID
- NCT00824772
- Acronym / sponsor ID
- 00012007317-00
- Conditions
- Pain, Postoperative
- Keywords
- pharmacogenetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Jan 2009 (estimated)
- Results
- Posted 27 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fentanyl is a widely used opioid analgesic. There are big interindividual variabilities in dose requirements of fentanyl for postoperative pain control. This study aims to reveal the genetic factors affecting the variable requirements of fentanyl during postoperative period.
Detailed description
The candidate genes are OPRM1, ABCB1,CYP3A4 and CYP3A5.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gynecologic patients undergoing total abdominal hysterectomy or laparoscpy assisted vaginal hysterectomy under general anesthesia
Key inclusion criteria (3 listed)
- Patients undergoing total abdominal hysterectomy (TAH) or laparoscopy assisted vaginal hysterectomy (LAVH) under general anesthesia
- Patients who want to use intravenous patient controlled analgesia (PCA) after surgery
- ASA physical status class I, II
Key exclusion criteria (11 listed)
- history of drug addiction
- opioid medication within 12 hours before surgery
- previous history of opioid medication for 3 months
- neurologic disorder
- cardiac disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Cumulative Fentanyl Consumption
Time frame: 24 hr after surgery
1 secondary outcome
Postoperative Cumulative Fentanyl Consumption
Time frame: 48hr after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23557865Kim KM, Kim HS, Lim SH, Cheong SH, Choi EJ, Kang H, Choi HR, Jeon JW, Yon JH, Oh M, Shin JG. Effects of genetic polymorphisms of OPRM1, ABCB1, CYP3A4/5 on postoperative fentanyl consumption in Korean gynecologic patients. Int J Clin Pharmacol Ther. 2013 May;51(5):383-92. doi: 10.5414/CP201824.
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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.
Kye-Min Kim, MD. PhD. principal investigator
Department of Anesthesia, Inje University Sanggye Paik Hospital
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, run by Inje University at 1 site in South Korea.
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 3 inclusion and 11 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 4 Jun 2013. 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 27 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Cumulative Fentanyl Consumption (time frame: 24 hr 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 NCT00824772, 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 4 Jun 2013.