Chronic Pain, Acute Pain, Cotinine, HysterectomyPhase 4NCT04274673
The Correlation Between Cotinine and Postoperative Acute and Chronic Pain After Hysterectomy
A Phase 4 study testing measuring cotinine level in people with Chronic Pain, Acute Pain, Cotinine, Hysterectomy, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
It is known that there is an association between smoking and acute/chronic pain. But it is so difficult to assess this relation with asking questions to the patients in the preoperative period. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Chronic Pain, Acute Pain, Cotinine, Hysterectomy
- What is being tested?
- measuring cotinine level
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2019to 15 May 2020
- Phase
- Phase 4
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II
- Open abdominal hysterectomy patients
Who cannot join
- Chronic pain
- Chronic pain killer users
- Axis I psychiatric disease
- Liver disease
- Renal disease
- Drug allergy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mustafa Kemal University Medicine Faculty Anesthesiology Department
Hatay, 31000
Onur Koyuncu, Assist. Prof, 5337744757, onurko@yahoo.com
Onur Koyuncu, Assoc.Prof
About this study
Official title: The Correlation Between the Cotinine Levels in Urine and Postoperative Acute and Chronic Pain in Open Abdominal Hysterectomy Patients
It is known that there is an association between smoking and acute/chronic pain. But it is so difficult to assess this relation with asking questions to the patients in the preoperative period. Because of that we want to measure the levels of the cotinine in the urine and later assess the correlation with acute and chronic pain in hysterectomy patients.
Read the detailed description
It is well-known that smoking is very common in the public. The chronic pain after hysterectomy is 20-40%. The open abdominal hysterectomy ratio is 75% of all hysterectomy operations in our country. We know that the reasons of postoperative acute and chronic pain is multifactorial. One of them is smoking which affects the postoperative pain. The best way of measuring the level of cotinine is assesing the urine of the patient. We collect the first urine after induction.
In this study, we aimed to investigate the correlation between the levels of urine cotinine and the acute and chronic postoperative pain in hysterectomy patents.
- Being tested
- measuring cotinine level
- Medical subject headings
- Chronic Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measuring cotinine levelDevice
Measuring of the cotinine levels
| Study group | Role | What they receive |
|---|---|---|
| low (less 10ng/dl) | Other | Patients who have low cotinine levels (less 10ng/dl) Receives: Device: measuring cotinine level |
| medium (10-500ng/dl) | Other | Patients who have medium cotinine levels (less 10-500ng/dl) Receives: Device: measuring cotinine level |
| high (more 500ng/dl) | Other | Patients who have high cotinine levels (less 10-500ng/dl) Receives: Device: measuring cotinine level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic pain: VAS score
3rd month pain after hysterectomy (VAS score)
Measured: Postoperative 3 months
Secondary outcomes (1)
Acute pain: VAS score
Postoperative 24 hrs after hysterectomy (VAS score)
Measured: Postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Dec 2019
- Primary completion13 May 2020 (estimated)
- Study completion15 May 2020 (estimated)
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 Chronic Pain, Acute Pain, Cotinine, HysterectomyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Koyuncu, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274673
- Sponsor's protocol ID
- 2017/181
- Status last verified
- Feb 2020
- First submitted
- 14 Feb 2020
- Last updated
- 18 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Montbriand JJ, Weinrib AZ, Azam MA, Ladak SSJ, Shah BR, Jiang J, McRae K, Tamir D, Lyn S, Katznelson R, Clarke HA, Katz J. Smoking, Pain Intensity, and Opioid Consumption 1-3 Months After Major Surgery: A Retrospective Study in a Hospital-Based Transitional Pain Service. Nicotine Tob Res. 2018 Aug 14;20(9):1144-1151. doi: 10.1093/ntr/ntx094.
PubMed 28472423
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between the Cotinine Levels in Urine and Postoperative Acute and Chronic Pain in Open Abdominal Hysterectomy Patients
- ClinicalTrials.gov ID
- NCT04274673
- Acronym / sponsor ID
- 2017/181
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 13 May 2020 (estimated)
- Study completion
- 15 May 2020 (estimated)
- First posted
- 18 Feb 2020 (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.
It is known that there is an association between smoking and acute/chronic pain. But it is so difficult to assess this relation with asking questions to the patients in the preoperative period. Because of that we want to measure the levels of the cotinine in the urine and later assess the correlation with acute and chronic pain in hysterectomy patients.
Detailed description
It is well-known that smoking is very common in the public. The chronic pain after hysterectomy is 20-40%. The open abdominal hysterectomy ratio is 75% of all hysterectomy operations in our country. We know that the reasons of postoperative acute and chronic pain is multifactorial. One of them is smoking which affects the postoperative pain. The best way of measuring the level of cotinine is assesing the urine of the patient. We collect the first urine after induction.
In this study, we aimed to investigate the correlation between the levels of urine cotinine and the acute and chronic postoperative pain in hysterectomy patents.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low (less 10ng/dl) | Other | Device: measuring cotinine levelPatients who have low cotinine levels (less 10ng/dl) |
| medium (10-500ng/dl) | Other | Device: measuring cotinine levelPatients who have medium cotinine levels (less 10-500ng/dl) |
| high (more 500ng/dl) | Other | Device: measuring cotinine levelPatients who have high cotinine levels (less 10-500ng/dl) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-II
- Open abdominal hysterectomy patients
Key exclusion criteria (6 listed)
- Chronic pain
- Chronic pain killer users
- Axis I psychiatric disease
- Liver disease
- Renal disease
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 |
|---|---|---|
| measuring cotinine levelMeasuring of the cotinine levels | Device | high (more 500ng/dl), low (less 10ng/dl), medium (10-500ng/dl) |
Primary outcome
Chronic pain: VAS score
Time frame: Postoperative 3 months
3rd month pain after hysterectomy (VAS score)
1 secondary outcome
Acute pain: VAS score
Time frame: Postoperative 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Background: PubMed 28472423Montbriand JJ, Weinrib AZ, Azam MA, Ladak SSJ, Shah BR, Jiang J, McRae K, Tamir D, Lyn S, Katznelson R, Clarke HA, Katz J. Smoking, Pain Intensity, and Opioid Consumption 1-3 Months After Major Surgery: A Retrospective Study in a Hospital-Based Transitional Pain Service. Nicotine Tob Res. 2018 Aug 14;20(9):1144-1151. doi: 10.1093/ntr/ntx094.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing measuring cotinine level in people with Chronic Pain, Acute Pain, Cotinine, Hysterectomy, run by Mustafa Kemal 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Feb 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Onur Koyuncu (+905337744757, onurko@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic pain: VAS score (time frame: Postoperative 3 months). 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 NCT04274673, 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 18 Feb 2020.