An interventional study of Subcostal Transversus Abdominis Plane Block in Menstrual Cycle and Subcostal Transversus Abdominis Plane Block, sponsored by Adiyaman University Research Hospital. Not yet recruiting at 1 site in Turkey. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by Adiyaman University Research Hospital · Not applicable, Interventional, and Treatment
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.
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.
Adiyaman University Research Hospital is the lead sponsor of 48 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Patients identified as being in the luteal phase by inquiring about the date of their last menstrual period.
Patients identified as being in the follicular phase by inquiring about the date of their last menstrual period.
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
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."
Time frame: postoperative 1st,2nd, 6.- 12.-24. hour
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
Time frame: postoperative 24. hour
Plan to share: No
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This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Adiyaman University Research Hospital