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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Menstrual Cycle; Subcostal Transversus Abdominis Plane Block
• Intervention / Treatment: Other: Subcostal Transversus Abdominis Plane 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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nezir YILMAZ, MD; Phone Number: +90 5068939496; Email: yilmaznezir@hotmail.com

Study Locations

• Turkey
  • Adıyaman, Turkey, 02200
    • Adıyaman Training and Research Hospital
    • Contact: Nezir YILMAZ, Dr; Phone Number: +905068939496; Email: yilmaznezir@hotmail.com
    • Contact: Nezir YILMAZ, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group LB; Patients that undergoing subcostal TAP block identified as being in the luteal phase by inquiring about the date of their last menstrual period.	Other: Subcostal Transversus Abdominis Plane Block; 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
Experimental: Group FB; Patients that undergoing subcostal TAP block identified as being in the follicular phase by inquiring about the date of their last menstrual period.	Other: Subcostal Transversus Abdominis Plane Block; 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
No Intervention: Group L; Patients identified as being in the luteal phase by inquiring about the date of their last menstrual period.
No Intervention: Group F; Patients identified as being in the follicular phase by inquiring about the date of their last menstrual period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	postoperative 1st,2nd, 6.- 12.-24. hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	postoperative 24. hour

Collaborators and Investigators

• Sponsor: Adiyaman University Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 14, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ADYU-ANS-NY-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No