Pain, PostoperativeNCT05897450
The Effects of TAP Block on Thiol/Disulfide Homeostasis and Pain in Laparoscopic Gynecological Surgery
A study testing Transversus abdominis plane (TAP) block and Local anesthetic infiltration in people with Pain, Postoperative and Oxidative Stress, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pain, Postoperative, Oxidative Stress
- What is being tested?
- Transversus abdominis plane (TAP) block and Local anesthetic infiltration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have undergone laparoscopic gynecological surgery
- Patients who agreed to participate in the study
Who cannot join
- Patients who did not agree to participate in the study
- Patients with missing data
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170
About this study
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.
Read the 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.
- Conditions
- Pain, Postoperative, Oxidative Stress
- Being tested
- Transversus abdominis plane (TAP) block, Local anesthetic infiltration
- Keywords
- thiol/disulphide homeostasis, TAP block, Laparoscopic Gynecological Surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Local anesthetic infiltrationOther
Local anesthetic infiltration was applied to the trocar sites with the same volume.
| Study group | Role | What they receive |
|---|---|---|
| Patients with TAP block | Active comparator | After induction of anesthesia, TAP block was applied to the patients under ultrasound guidance. Receives: Other: Transversus abdominis plane (TAP) block |
| Patients without TAP block | Other | Local anesthetic infiltration was applied to the trocar sites with the same volume. Receives: Other: Local anesthetic infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: postoperative 24th hour
Secondary outcomes (1)
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.
Measured: 0 hours postoperatively, 2 hours postoperatively,4 hours postoperatively,8 hours postoperatively,12 hours postoperatively,24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start15 Jul 2023
- Primary completion15 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yusuf Özgüner, Ankara Etlik City Hospital
- Investigators
- Yusuf Ozguner, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897450
- Sponsor's protocol ID
- AnkaraEtlikYusufOzguner002
- Status last verified
- Jun 2025
- First submitted
- 1 Jun 2023
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25304913Oksuz 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.
PubMed 34614288Baeriswyl 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.
PubMed 26397443
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of TAP Block on Thiol/Disulfide Homeostasis and Pain in Laparoscopic Gynecological Surgery
- ClinicalTrials.gov ID
- NCT05897450
- Acronym / sponsor ID
- AnkaraEtlikYusufOzguner002
- Conditions
- Pain, Postoperative, Oxidative Stress
- Keywords
- thiol/disulphide homeostasis, TAP block, Laparoscopic Gynecological Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with TAP block | Active comparator | Other: Transversus abdominis plane (TAP) blockAfter induction of anesthesia, TAP block was applied to the patients under ultrasound guidance. |
| Patients without TAP block | Other | Other: Local anesthetic infiltrationLocal anesthetic infiltration was applied to the trocar sites with the same volume. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have undergone laparoscopic gynecological surgery
- Patients who agreed to participate in the study
Key exclusion criteria (2 listed)
- Patients who did not agree to participate in the study
- Patients with missing data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transversus abdominis plane (TAP) blockTransversus abdominis plane (TAP) block: injection of a local anesthetic into a region between the internal oblique and transversus abdominis muscles. | Other | Patients with TAP block |
| Local anesthetic infiltrationLocal anesthetic infiltration was applied to the trocar sites with the same volume. | Other | Patients without TAP block |
Primary outcome
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).
Thiol/Disulphide Homeostasis
Time frame: postoperative 24th hour
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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Background: PubMed 25304913Erel 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.
- Background: PubMed 34614288Oksuz 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.
- Background: PubMed 26397443Baeriswyl 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yusuf Ozguner principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus abdominis plane (TAP) block and Local anesthetic infiltration in people with Pain, Postoperative and Oxidative Stress, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thiol/Disulphide Homeostasis (time frame: 5 minutes before induction of anesthesia). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05897450, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.