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

Adiyaman University Research Hospital

Status: Not yet enrolling

Conditions: Subcostal Transversus Abdominis Plane Block; Menstrual Cycle

Treatments: Other: Subcostal Transversus Abdominis Plane Block

Study type: Interventional

Funder types: Other

Identifiers

NCT06566365

ADYU-ANS-NY-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups

Group LB

Experimental group

Description:

Patients that undergoing subcostal TAP block identified as being in the luteal phase by inquiring about the date of their last menstrual period.

Treatment:

Other: Subcostal Transversus Abdominis Plane Block

Group FB

Experimental group

Description:

Patients that undergoing subcostal TAP block identified as being in the follicular phase by inquiring about the date of their last menstrual period.

Treatment:

Other: Subcostal Transversus Abdominis Plane Block

Group L

No Intervention group

Description:

Patients identified as being in the luteal phase by inquiring about the date of their last menstrual period.

Group F

No Intervention group

Description:

Patients identified as being in the follicular phase by inquiring about the date of their last menstrual period.