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

Sponsor
Ankara Etlik City Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05897450
Collaborator
(none)
60
1
5
11.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Transversus abdominis plane (TAP) block

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Effects of TAP Block on Thiol/Disulfide Homeostasis and Pain in Laparoscopic Gynecological Surgery
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Patients with TAP block

After induction of anesthesia, TAP block was applied to the patients under ultrasound guidance.

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.

Patients without TAP block

Outcome Measures

Primary Outcome Measures

  1. Thiol/Disulphide Homeostasis [5 minutes before induction of anesthesia]

    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).

  2. Thiol/Disulphide Homeostasis [at the time of the surgery over]

    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).

Secondary Outcome Measures

  1. Pain on the Numeric Rating Scale (NRS) [0 hours postoperatively, 2 hours postoperatively,4 hours postoperatively,8 hours postoperatively,12 hours postoperatively,24 hours postoperatively]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara Etlik City Hospital Ankara Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle Turkey 06170

Sponsors and Collaborators

  • Ankara Etlik City Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yusuf Özgüner, Principal Investigator, Ankara Etlik City Hospital
ClinicalTrials.gov Identifier:
NCT05897450
Other Study ID Numbers:
  • AnkaraEtlikYusufOzguner002
First Posted:
Jun 9, 2023
Last Update Posted:
Jun 12, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yusuf Özgüner, Principal Investigator, Ankara Etlik City Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 12, 2023