Effect of Hormonal Cahanges During Menstrual Cycle on Subcostal Transversus Abdominis Plane Block

NCT06566365 — Not applicable, Not yet recruiting, 80 participants, Adiyaman University Research Hospital

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Effect of Hormonal Cahanges During Menstrual Cycle on Subcostal Transversus Abdominis

Registry	NCT06566365
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	80 (Estimated)
Sponsor	Adiyaman University Research Hospital (Other)
Conditions	Menstrual Cycle, Subcostal Transversus Abdominis Plane Block
Interventions	Subcostal Transversus Abdominis Plane Block (Other)
Dates	start 2024-11-15 (estimated), primary completion 2024-12-30 (estimated), completion 2024-12-31 (estimated), first posted 2024-08-22, last updated 2024-11-14
Locations	1 site in Turkey (Türkiye)

-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 . 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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Group LB	Experimental	Other: Subcostal Transversus Abdominis Plane Block	Patients 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 Block	Patients 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.

Subcostal Transversus Abdominis Plane Block (Other): 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

+Outcome measures

Primary outcomes

visual analogue scale (VAS) [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."

Secondary outcomes

Quality of Recovery - 15 [postoperative 24. hour]: 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

+Eligibility

Sex: Female, ages: 18 Years to 65 Years

Inclusion Criteria:

* ASA I-II, female, Laparoscopic cholecyctectomy, Subcostal TAP , 18-65 years old patient

Exclusion Criteria:

* ASA III-IV
* <18 , >65 years old patients
* menstrual disorders

+Locations (1)

Facility	City	Country	Status
Adıyaman Training and Research Hospital	Adıyaman	Turkey (Türkiye)