Menstrual CycleNCT06566365
Effect of Hormonal Cahanges During Menstrual Cycle on Subcostal Transversus Abdominis Plane Block
A study testing Subcostal Transversus Abdominis Plane Block in people with Menstrual Cycle and Subcostal Transversus Abdominis Plane Block, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Fascial plane blocks are traditionally considered regional anesthesia techniques, where a mixture of local anesthetic (LA) is injected into a plane between two fascial layers, with the aim of spreading along this anatomical plane to block the nerves lying within or passing through it . Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Menstrual Cycle, Subcostal Transversus Abdominis Plane Block
- What is being tested?
- Subcostal Transversus Abdominis Plane Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II, female, Laparoscopic cholecyctectomy, Subcostal TAP , 18-65 years old patient
Who cannot join
- ASA III-IV
- <18 , >65 years old patients
- menstrual disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Adıyaman Training and Research Hospital
Adıyaman, 02200
Nezir YILMAZ, Dr, +905068939496, yilmaznezir@hotmail.com
Nezir YILMAZ, Dr
About this study
Official title: Effect of Hormonal Cahanges During Menstrual Cycle on Subcostal Transversus Abdominis
Fascial plane blocks are traditionally considered regional anesthesia techniques, where a mixture of local anesthetic (LA) is injected into a plane between two fascial layers, with the aim of spreading along this anatomical plane to block the nerves lying within or passing through it . Various pathophysiological processes that alter the structure and characteristics of fasciae can affect the spread of the local anesthetic and the success of the block. Diabetes, hormonal changes, and cannabinoid use are among these factors. This study aims to investigate the effects of hormonal changes during the menstrual cycle on subcostal TAP block.
Read the detailed description
Female patients scheduled for laparoscopic cholecystectomy at Adıyaman University Training and Research Hospital, who have been informed about the study and have provided written consent to participate, will be included in the study. The patients who agree to participate will be divided into groups based on the phases of their menstrual cycles. After ensuring airway safety under general anesthesia, a bilateral TAP block using 20 cc of 0.25% bupivacaine with a subcostal approach under ultrasound guidance will be administered to both groups. The study aims to compare the hemodynamic values (arterial blood pressure, heart rate, peripheral oxygen saturation) during the perioperative period, the visual analog scale (VAS) scores postoperatively, and the Quality of Recovery-15 (QoR-15) scores at 24 hours postoperatively between the two groups. This will allow for the investigation of the effects of hormonal changes during the menstrual cycle on the efficacy and success of subcostal TAP blocks.
- Being tested
- Subcostal Transversus Abdominis Plane Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcostal Transversus Abdominis Plane BlockOther
After ensuring airway safety under general anesthesia, a bilateral Transversus Abdominis Plane Block using 20 cc of 0.25% bupivacaine with a subcostal approach under ultrasound guidance will be administered
| Study group | Role | What they receive |
|---|---|---|
| Group LB | Experimental | Patients that undergoing subcostal TAP block identified as being in the luteal phase by inquiring about the date of their last menstrual period. Receives: Other: Subcostal Transversus Abdominis Plane Block |
| Group FB | Experimental | Patients that undergoing subcostal TAP block identified as being in the follicular phase by inquiring about the date of their last menstrual period. Receives: Other: Subcostal Transversus Abdominis Plane Block |
| Group L | No intervention | Patients identified as being in the luteal phase by inquiring about the date of their last menstrual period. |
| Group F | No intervention | Patients identified as being in the follicular phase by inquiring about the date of their last menstrual period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale (VAS)
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: postoperative 1st,2nd, 6.- 12.-24. hour
Secondary outcomes (1)
Quality of Recovery - 15
The QoR-15 scale is a unidimensional measurement of quality of recovery measured in five domains: physical comfort, pain, physical independence, psychological support, and emotional state. The QoR-15 scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery
Measured: postoperative 24. hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start15 Nov 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CycleStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nezir Yılmaz, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566365
- Sponsor's protocol ID
- ADYU-ANS-NY-06
- Status last verified
- Nov 2024
- First submitted
- 21 Aug 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hormonal Cahanges During Menstrual Cycle on Subcostal Transversus Abdominis
- ClinicalTrials.gov ID
- NCT06566365
- Acronym / sponsor ID
- ADYU-ANS-NY-06
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Aug 2024 (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.
Fascial plane blocks are traditionally considered regional anesthesia techniques, where a mixture of local anesthetic (LA) is injected into a plane between two fascial layers, with the aim of spreading along this anatomical plane to block the nerves lying within or passing through it . Various pathophysiological processes that alter the structure and characteristics of fasciae can affect the spread of the local anesthetic and the success of the block. Diabetes, hormonal changes, and cannabinoid use are among these factors. This study aims to investigate the effects of hormonal changes during the menstrual cycle on subcostal TAP block.
Detailed description
Female patients scheduled for laparoscopic cholecystectomy at Adıyaman University Training and Research Hospital, who have been informed about the study and have provided written consent to participate, will be included in the study. The patients who agree to participate will be divided into groups based on the phases of their menstrual cycles. After ensuring airway safety under general anesthesia, a bilateral TAP block using 20 cc of 0.25% bupivacaine with a subcostal approach under ultrasound guidance will be administered to both groups. The study aims to compare the hemodynamic values (arterial blood pressure, heart rate, peripheral oxygen saturation) during the perioperative period, the visual analog scale (VAS) scores postoperatively, and the Quality of Recovery-15 (QoR-15) scores at 24 hours postoperatively between the two groups. This will allow for the investigation of the effects of hormonal changes during the menstrual cycle on the efficacy and success of subcostal TAP blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group LB | Experimental | Other: Subcostal Transversus Abdominis Plane BlockPatients that undergoing subcostal TAP block identified as being in the luteal phase by inquiring about the date of their last menstrual period. |
| Group FB | Experimental | Other: Subcostal Transversus Abdominis Plane BlockPatients that undergoing subcostal TAP block identified as being in the follicular phase by inquiring about the date of their last menstrual period. |
| Group L | No intervention | –Patients identified as being in the luteal phase by inquiring about the date of their last menstrual period. |
| Group F | No intervention | –Patients identified as being in the follicular phase by inquiring about the date of their last menstrual period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA I-II, female, Laparoscopic cholecyctectomy, Subcostal TAP , 18-65 years old patient
Key exclusion criteria (3 listed)
- ASA III-IV
- <18 , >65 years old patients
- menstrual disorders
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 |
|---|---|---|
| Subcostal Transversus Abdominis Plane BlockAfter ensuring airway safety under general anesthesia, a bilateral Transversus Abdominis Plane Block using 20 cc of 0.25% bupivacaine with a subcostal approach under ultrasound guidance will be administered | Other | Group FB, Group LB |
Primary outcome
visual analogue scale (VAS)
Time frame: postoperative 1st,2nd, 6.- 12.-24. hour
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
1 secondary outcome
Quality of Recovery - 15
Time frame: postoperative 24. hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subcostal Transversus Abdominis Plane Block in people with Menstrual Cycle and Subcostal Transversus Abdominis Plane Block, run by Adiyaman University Research Hospital 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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 14 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nezir YILMAZ, MD (+90 5068939496, yilmaznezir@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (VAS) (time frame: postoperative 1st,2nd, 6.- 12.-24. hour). 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 14 Nov 2024.