The Effects of TAP Block on Thiol/Disulfide Homeostasis and Pain in Laparoscopic Gynecological Surgery

Pain, Postoperative Clinical Trial

Official title:

The Effects of TAP Block on Thiol/Disulfide Homeostasis and Pain in Laparoscopic Gynecological Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05897450
• Other study ID #: AnkaraEtlikYusufOzguner002
• Status: Not yet recruiting
• Start date: July 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: June 2023
• Source: Ankara Etlik City Hospital
• Contact: Yusuf Ozguner
• Phone: +905427150725
• Email: y.ozguner[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. In addition, the relationship between postoperative pain levels and Thiol/Disulfide homeostasis will be investigated.

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. In addition, the relationship between postoperative pain levels and Thiol/Disulfide homeostasis will be investigated.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Oxidative Stress
• Pain, Postoperative

Intervention

Other:
• Transversus abdominis plane (TAP) block
Transversus abdominis plane (TAP) block: injection of a local anesthetic into a region between the internal oblique and transversus abdominis muscles.

Locations

Country	Name	City	State
Turkey	Ankara Etlik City Hospital	Ankara	Varlik Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Etlik City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thiol/Disulphide Homeostasis	In order to determine thiol / disulphide homeostasis, 5 ml blood samples were taken 2 times from each patient (T1: 5 minutes before induction of anesthesia, T2: at the time of the surgery over).	5 minutes before induction of anesthesia
Primary	Thiol/Disulphide Homeostasis	In order to determine thiol / disulphide homeostasis, 5 ml blood samples were taken 2 times from each patient (T1: 5 minutes before induction of anesthesia, T2: at the time of the surgery over).	at the time of the surgery over
Secondary	Pain on the Numeric Rating Scale (NRS)	Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points: 0 hours postoperatively, 2 hours postoperatively, 4 hours postoperatively, 8 hours postoperatively, 12 hours postoperatively, 24 hours postoperatively. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.	0 hours postoperatively, 2 hours postoperatively,4 hours postoperatively,8 hours postoperatively,12 hours postoperatively,24 hours postoperatively