Effect of Hormonal Cahanges During Menstrual Cycle on Subcostal Transversus Abdominis Plane Block
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Subcostal Transversus Abdominis Plane Block.
- Who it may be relevant to
- Registry conditions: Menstrual Cycle, Subcostal Transversus Abdominis Plane Block. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Hormonal Cahanges During Menstrual Cycle on Subcostal Transversus Abdominis
Overview
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.
Interventions
- 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
Primary outcome measures
- visual analogue scale (VAS) [Time frame: postoperative 1st,2nd, 6.- 12.-24. hour]
Secondary outcome measures (1)
- Quality of Recovery - 15 [Time frame: postoperative 24. hour]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Adıyaman Training and Research Hospital — Adıyaman
Identifiers
NCT: NCT06566365 · ADYU-ANS-NY-06