Pain, PostoperativeNCT02496455
The Impact of the SCN9A Gene Polymorphism on Postoperative Pain
An observational study of Pain, Postoperative and Pregnancy, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study to determine the association between postoperative pain after cesarean section and several single nucleotide polymorphisms in SCN9A sodium channels gene. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pain, Postoperative, Pregnancy
- What is being tested?
- cesarean section and Opioid Tramadol
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2015to Nov 2017
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: The women in 36 to 40 weeks of pregnancy undergoing cesarean section will be included
Who may be able to join
- The women aged 18 to 45,
- in 36 to 40 weeks of pregnancy
- undergoing cesarean section
Who cannot join
- History of chronic pain or pain disorders
- Psychiatric diseases
- Diabetes mellitus
- Severe cardiovascular, kidney or liver diseases
- Alcohol or drug abuse
- Heavy smoker
- Unable to use the Patient controlled analgesia (PCA) pump
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University Medical School Hospital
Tokat Province, 60100
About this study
Official title: The Impact of the Single Nucleotide Polymorphisms rs6746030,rs7604448, rs10930214, s7595255 in SCN9A Gene on Postoperative Pain and Analgesic Consumption After Cesarean Section
The purpose of this study to determine the association between postoperative pain after cesarean section and several single nucleotide polymorphisms in SCN9A sodium channels gene.
Read the detailed description
SCN9A gene encodes an alpha subunit of the voltage-gated sodium channel (Nav1.7) and polymorphisms of this gene are associated with severe pain disorders. The impact of the polymorphisms in SCN9A on postoperative pain and opioid consumption after cesarean section is unclear.
- Conditions
- Pain, Postoperative, Pregnancy
- Being tested
- cesarean section, Opioid Tramadol
- Keywords
- NAV1.7 Voltage-Gated Sodium Channel, pain, postoperative, cesarean section
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cesarean sectionProcedure or surgery
Women in 36 to 40 weeks of pregnancy undergoing cesarean section by Pfannenstiel technique
Opioid TramadolDrug
Also called Tramadol (contramal)
Tramadol will be administered via patient controlled analgesia (PCA) pump in the postoperative period
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
The pain will be evaluated with the visual analog scale
Measured: up to postoperative 24 hours
Secondary outcomes (1)
Opioid consumption
The total amount of the tramadol administered to the patient will be recorded
Measured: Up to postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Karaman, Tokat Gaziosmanpasa University
- Investigators
- Tugba Karaman, M.D., Principal investigator, Gaziosmanpasa University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496455
- Sponsor's protocol ID
- GEN-S
- Status last verified
- Aug 2017
- First submitted
- 9 Jul 2015
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the Single Nucleotide Polymorphisms rs6746030,rs7604448, rs10930214, s7595255 in SCN9A Gene on Postoperative Pain and Analgesic Consumption After Cesarean Section
- ClinicalTrials.gov ID
- NCT02496455
- Acronym / sponsor ID
- GEN-S
- Conditions
- Pain, Postoperative, Pregnancy
- Keywords
- NAV1.7 Voltage-Gated Sodium Channel, pain, postoperative, cesarean section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- May 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 14 Jul 2015 (estimated)
- 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.
The purpose of this study to determine the association between postoperative pain after cesarean section and several single nucleotide polymorphisms in SCN9A sodium channels gene.
Detailed description
SCN9A gene encodes an alpha subunit of the voltage-gated sodium channel (Nav1.7) and polymorphisms of this gene are associated with severe pain disorders. The impact of the polymorphisms in SCN9A on postoperative pain and opioid consumption after cesarean section is unclear.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The women in 36 to 40 weeks of pregnancy undergoing cesarean section will be included
Key inclusion criteria (3 listed)
- The women aged 18 to 45,
- in 36 to 40 weeks of pregnancy
- undergoing cesarean section
Key exclusion criteria (7 listed)
- History of chronic pain or pain disorders
- Psychiatric diseases
- Diabetes mellitus
- Severe cardiovascular, kidney or liver diseases
- Alcohol or drug abuse
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 |
|---|---|---|
| cesarean sectionWomen in 36 to 40 weeks of pregnancy undergoing cesarean section by Pfannenstiel technique | Procedure or surgery | – |
| Opioid TramadolAlso: Tramadol (contramal)Tramadol will be administered via patient controlled analgesia (PCA) pump in the postoperative period | Drug | – |
Primary outcome
Pain
Time frame: up to postoperative 24 hours
The pain will be evaluated with the visual analog scale
1 secondary outcome
Opioid consumption
Time frame: Up to postoperative 24 hours
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 21 Nov 2017.
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Tugba Karaman, M.D. principal investigator
Gaziosmanpasa University Medical School
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 Pregnancy, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
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 7 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 21 Nov 2017. 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 Turkey (Türkiye). 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?
Pain (time frame: up to postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2017.