Clinical trial NCT05897450: The Effects of TAP Block on Thiol/Disulfide Homeostasis and Pain in Laparoscopic Gynecological Surgery
Official title: The Effects of TAP Block on Thiol/Disulfide Homeostasis and Pain in Laparoscopic Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Oxidative Stress
Keywords: thiol/disulphide homeostasis
TAP block
Laparoscopic Gynecological Surgery
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-06-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In the study, it was aimed to compare patients who underwent laparoscopic gynecological surgery with and without TAP block in terms of postoperative pain levels and Thiol/Disulfide homeostasis.

Detailed description: Thiols are organic sulphur derivatives containing Sulfhydryl Residues (-SH) in their active regions. Thiols easily react with oxygen containing free radicals to form disulfides. This is a defence mechanism against oxidative stress.7 An automated analysis quantitatively measuring serum native and total thiol, and disulfides has been recently described as a method to determine dynamic Thiol/Disulfide Homeostasis (TDH).The role of dynamic thioldisulfide homeostasis has been increasingly shown in many diseases. There is a growing number of evidences that an abnormal thiol-disulfide homeostasis may play role in the pathogenesis of a variety of diseases such as cardiovascular disease, malignancies, rheumatoid arthritis, chronic kidney disease, and acquired immunodeficiency syndrome.

Laparoscopic gynecological surgery has several advantages when compared to open surgery, including faster postoperative recovery and lower pain scores. However, the possibility of significant postoperative pain remains. Trocar placement, tissue dissection, and pneumoperitoneum formation contribute to postoperative pain in laparoscopic surgery. If this pain is not treated adequately, it can cause an increase in pain levels, nausea and vomiting, and as a result, a decrease in patient comfort and a prolongation of hospitalization. Ultrasound-guided transversus abdominis plane (TAP) block is easy to perform and has recently become a popular technique for reducing postoperative pain after abdominal surgery. It has been reported that it provides effective postoperative analgesia with a decrease in opioid consumption in various open abdominal surgical procedures and contributes to faster patient recovery.

In the study, it was aimed to compare patients who underwent laparoscopic gynecological surgery with and without TAP block in terms of postoperative pain levels and Thiol/Disulfide homeostasis.

Eligibility criteria: Inclusion Criteria:

* Patients who have undergone laparoscopic gynecological surgery
* Patients who agreed to participate in the study

Exclusion Criteria:

* Patients who did not agree to participate in the study
* Patients with missing data

Primary outcomes:
measure: Thiol/Disulphide Homeostasis
timeFrame: 5 minutes before induction of anesthesia
measure: Thiol/Disulphide Homeostasis
timeFrame: postoperative 24th hour
Secondary outcomes:
measure: Pain on the Numeric Rating Scale (NRS)
timeFrame: 0 hours postoperatively, 2 hours postoperatively,4 hours postoperatively,8 hours postoperatively,12 hours postoperatively,24 hours postoperatively
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle
Study officials:
affiliation: Ankara Etlik City Hospital
name: Yusuf Ozguner
role: PRINCIPAL_INVESTIGATOR
References:
citation: Erel O, Neselioglu S. A novel and automated assay for thiol/disulphide homeostasis. Clin Biochem. 2014 Dec;47(18):326-32. doi: 10.1016/j.clinbiochem.2014.09.026. Epub 2014 Oct 7.
citation: Oksuz M, Abitagaoglu S, Kaciroglu A, Koksal C, Ozturk BY, Erel O, Senat A, Erdogan Ari D. Effects of general anaesthesia and ultrasonography-guided interscalene block on pain and oxidative stress in shoulder arthroscopy: A randomised trial. Int J Clin Pract. 2021 Dec;75(12):e14948. doi: 10.1111/ijcp.14948. Epub 2021 Oct 12.
citation: Baeriswyl M, Kirkham KR, Kern C, Albrecht E. The Analgesic Efficacy of Ultrasound-Guided Transversus Abdominis Plane Block in Adult Patients: A Meta-Analysis. Anesth Analg. 2015 Dec;121(6):1640-54. doi: 10.1213/ANE.0000000000000967.