NCT05897450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 15, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

June 6, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

June 1, 2023

Last Update Submit

June 4, 2025

Conditions

Pain, PostoperativeOxidative Stress

Keywords

thiol/disulphide homeostasisTAP blockLaparoscopic Gynecological Surgery

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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).

    postoperative 24th hour

Secondary Outcomes (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

Study Arms (2)

Patients with TAP block

ACTIVE COMPARATOR

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

Other: Transversus abdominis plane (TAP) block

Patients without TAP block

OTHER

Local anesthetic infiltration was applied to the trocar sites with the same volume.

Other: Local anesthetic infiltration

Interventions

Transversus abdominis plane (TAP) blockOTHER

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

Patients with TAP block
Local anesthetic infiltrationOTHER

Local anesthetic infiltration was applied to the trocar sites with the same volume.

Patients without TAP block

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 25304913BACKGROUND

  • 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.

    PMID: 34614288BACKGROUND

  • 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.

    PMID: 26397443BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Yusuf Ozguner

    Ankara Etlik City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2023

First Posted

June 9, 2023

Study Start

July 15, 2023

Primary Completion

December 15, 2023

Study Completion

December 30, 2023

Last Updated

June 6, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)