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

June 8, 2023 updated by: Yusuf Özgüner, Ankara Etlik City Hospital
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle
      • Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, Turkey, 06170
        • Ankara Etlik City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who had laparoscopic gynecological surgery and agreed to participate in the study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thiol/Disulphide Homeostasis
Time Frame: 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).
5 minutes before induction of anesthesia
Thiol/Disulphide Homeostasis
Time Frame: 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).
at the time of the surgery over

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain on the Numeric Rating Scale (NRS)
Time Frame: 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.
0 hours postoperatively, 2 hours postoperatively,4 hours postoperatively,8 hours postoperatively,12 hours postoperatively,24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Etlik City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

June 1, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 9, 2023

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnkaraEtlikYusufOzguner002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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