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

NCT06566365 | Not Yet Recruiting

• 1 other identifier: ADYU-ANS-NY-06
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menstrual Cycle; Subcostal Transversus Abdominis Plane Block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of Recovery - 15

  postoperative 24. hour

Study Arms (4)

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.

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.

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.

Interventions

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

Group FB; Group LB

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Adiyaman University Research Hospital: lead

Study Sites (1)

Adıyaman Training and Research Hospital

Adıyaman, 02200, Turkey (Türkiye)

Location

Central Study Contacts

Nezir YILMAZ, MD

CONTACT

+90 5068939496; yilmaznezir@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 22, 2024
• Study Start: November 15, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 31, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)