Gynecological; Surgery (Previous), Affecting FetusNCT04690491
Mü-opioid Receptor Level and Postoperative Pain in Patients With Gynecological Laparoscopy
An observational study of Gynecological; Surgery (Previous), Affecting Fetus and Postoperative Pain, run by Bozok University at 1 site in Turkey (Türkiye).
Trial summary
The hypothesis that gonadal hormones may affect the perception of pain is an interesting research area. This prospective observational study will undergo elective laparoscopic gynecological surgery to 18-65 years, is planned to participate in ASA 1-3, 60 volunteer patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecological; Surgery (Previous), Affecting Fetus, Postoperative Pain
- What is being tested?
- follicular cyclus and luteal cyclus
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2020to 2 Apr 2021
- How long will I take part?
- 6 Months
- 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
- Healthy volunteers accepted
- Adult
Study population: Volunteer patients to undergo elective laparoscopic gynecological surgery by the Department of Obstetrics and Gynecology
Who may be able to join
- Volunteer,
- Between the Ages of 18-45,
- Least Primary School Graduate,
- Not Using Drugs That May Affect Cognitive Functions,
- Non-Alcohol Substance Use,
- Patients Without Psychiatric and Neurological Disease.
- Those with regular and predictable menstrual cycles
Who cannot join
- Those with known psychiatric disease and drugs,
- Those with an important cardiovascular or central nervous system disease,
- Patients with pain syndromes or routinely using opioid,
- Those whose menstrual cycles last less than 21 days and do not have an irregular and predictable menstrual cycle
- Very urgent patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Menstrual Cyclus Phases of Menstrual Cyclus Phases and Postoperative Pain in Patients With Gynecological Laparoscopy
The hypothesis that gonadal hormones may affect the perception of pain is an interesting research area.
This prospective observational study will undergo elective laparoscopic gynecological surgery to 18-65 years, is planned to participate in ASA 1-3, 60 volunteer patients.
Read more
Patients who have known psychiatric disease and drug-users, an important cardiovascular or central nervous system disease, patients with pain syndromes or routinely using opioid, are non-irregular and predictable cycles of menstrual cycles and very urgent patients will not be included in the study.
In our study, we aimed to determine the relationship between menstrual cyclus phases (follicular and luteal) of menstrual cyclus phases (follicular and luteal) in patients to undergo gynecological laparoscopic operation and the relationship between postoperative pain and opioid analgesic consumption.
Read the detailed description
This prospective observational study is planned to include 60 volunteer patients aged 18-45, ASA 1-3, undergoing elective laparoscopic gynecological surgery. With the information to be obtained from the patients whose menstrual cycle regularly lasts 21-35 days, the cycle duration will be determined by counting from the first day of the last mens period. Days 6-12 of the cycle will be grouped as follicular (F), and 20-24 as luteal (L). No surgery will be planned during the mens period (1-5 days). Patients will be excluded on days 13-19 of the cycle to better define the two stages.
Remaining 3 ml of blood from routine venous blood samples taken from patients for preoperative evaluation will be stored to investigate μ-Opioid receptor levels. A continuous 10 cm visual analog scale (VAS) will be used to determine the level of postoperative pain.
Researchers who will make postoperative evaluations will be blind to menstrual cycles.
The sensation of pain will be assessed every 10 minutes in the recovery room, intervening with a bolus of 10 mg iv tramadol for a pain score of 3 to 5 and a bolus of 20 mg for a pain score of more than 5. If the VAS does not drop below 3 after two additional tramadol boluses, rescue analgesia will be provided with 2 mg iv morphine.
Patients will be followed in the ward and observations will be made at 6, 12 and 24 hours.
Patients will be asked to evaluate their resting and coughing pains.
- Being tested
- follicular cyclus, luteal cyclus
- Keywords
- Mu-opioid receptor, Gynecological laparoscopic operation, menstrual cycle
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follicular cyclusOther
Days of cyclus 6-12
luteal cyclusOther
Days of cyclus 20-24
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between mu opioid receptor levels in menstrual cycle phases
Measured: 6 months
Secondary outcomes (1)
Correlation between mu opioid receptor levels and postoperative pain
Correlation between mu opioid receptor levels and postoperative pain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start15 May 2020
- Primary completion1 Apr 2021
- Study completion2 Apr 2021
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 Gynecological; Surgery (Previous), Affecting FetusStudies 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
- 80 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ökkeş Hakan Miniksar, Bozok University
- Investigators
- Ökkeş Miniksar, Asist.Prof, Study chair, Yozgat Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690491
- Sponsor's protocol ID
- 189_2019.12.11_07
- Status last verified
- Apr 2021
- First submitted
- 22 Dec 2020
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miniksar OH, Onat T, Gocmen AY, Honca M. Serum levels of mu-opioid receptor according to menstrual cycle phases are associated with postoperative pain and opioid consumption in laparoscopic gynecological surgeries: a prospective observational study. Ir J Med Sci. 2023 Aug;192(4):1847-1854. doi: 10.1007/s11845-022-03146-z. Epub 2022 Sep 12.
PubMed 36094733
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Menstrual Cyclus Phases of Menstrual Cyclus Phases and Postoperative Pain in Patients With Gynecological Laparoscopy
- ClinicalTrials.gov ID
- NCT04690491
- Acronym / sponsor ID
- 189_2019.12.11_07
- Keywords
- Mu-opioid receptor, Gynecological laparoscopic operation, menstrual cycle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 30 Dec 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.
The hypothesis that gonadal hormones may affect the perception of pain is an interesting research area.
This prospective observational study will undergo elective laparoscopic gynecological surgery to 18-65 years, is planned to participate in ASA 1-3, 60 volunteer patients.
Patients who have known psychiatric disease and drug-users, an important cardiovascular or central nervous system disease, patients with pain syndromes or routinely using opioid, are non-irregular and predictable cycles of menstrual cycles and very urgent patients will not be included in the study.
In our study, we aimed to determine the relationship between menstrual cyclus phases (follicular and luteal) of menstrual cyclus phases (follicular and luteal) in patients to undergo gynecological laparoscopic operation and the relationship between postoperative pain and opioid analgesic consumption.
Detailed description
This prospective observational study is planned to include 60 volunteer patients aged 18-45, ASA 1-3, undergoing elective laparoscopic gynecological surgery. With the information to be obtained from the patients whose menstrual cycle regularly lasts 21-35 days, the cycle duration will be determined by counting from the first day of the last mens period. Days 6-12 of the cycle will be grouped as follicular (F), and 20-24 as luteal (L). No surgery will be planned during the mens period (1-5 days). Patients will be excluded on days 13-19 of the cycle to better define the two stages.
Remaining 3 ml of blood from routine venous blood samples taken from patients for preoperative evaluation will be stored to investigate μ-Opioid receptor levels. A continuous 10 cm visual analog scale (VAS) will be used to determine the level of postoperative pain.
Researchers who will make postoperative evaluations will be blind to menstrual cycles.
The sensation of pain will be assessed every 10 minutes in the recovery room, intervening with a bolus of 10 mg iv tramadol for a pain score of 3 to 5 and a bolus of 20 mg for a pain score of more than 5. If the VAS does not drop below 3 after two additional tramadol boluses, rescue analgesia will be provided with 2 mg iv morphine.
Patients will be followed in the ward and observations will be made at 6, 12 and 24 hours.
Patients will be asked to evaluate their resting and coughing pains.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Volunteer patients to undergo elective laparoscopic gynecological surgery by the Department of Obstetrics and Gynecology
Key inclusion criteria (7 listed)
- Volunteer,
- Between the Ages of 18-45,
- Least Primary School Graduate,
- Not Using Drugs That May Affect Cognitive Functions,
- Non-Alcohol Substance Use,
Key exclusion criteria (5 listed)
- Those with known psychiatric disease and drugs,
- Those with an important cardiovascular or central nervous system disease,
- Patients with pain syndromes or routinely using opioid,
- Those whose menstrual cycles last less than 21 days and do not have an irregular and predictable menstrual cycle
- Very urgent patients
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 |
|---|---|---|
| follicular cyclusDays of cyclus 6-12 | Other | – |
| luteal cyclusDays of cyclus 20-24 | Other | – |
Primary outcome
Difference between mu opioid receptor levels in menstrual cycle phases
Time frame: 6 months
1 secondary outcome
Correlation between mu opioid receptor levels and postoperative pain
Time frame: 6 months
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 20 Apr 2021.
- Derived from this study: PubMed 36094733Miniksar OH, Onat T, Gocmen AY, Honca M. Serum levels of mu-opioid receptor according to menstrual cycle phases are associated with postoperative pain and opioid consumption in laparoscopic gynecological surgeries: a prospective observational study. Ir J Med Sci. 2023 Aug;192(4):1847-1854. doi: 10.1007/s11845-022-03146-z. Epub 2022 Sep 12.
- Individual participant dataSharing planned: No
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.
Ökkeş Miniksar, Asist.Prof study chair
Yozgat Bozok 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 Gynecological; Surgery (Previous), Affecting Fetus and Postoperative Pain, run by Bozok 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 7 inclusion and 5 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 20 Apr 2021. 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?
Difference between mu opioid receptor levels in menstrual cycle phases (time frame: 6 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 NCT04690491, 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 20 Apr 2021.