Gynecologic Laparoscopic SurgeryNCT06995404
Transversus Abdominis Plane Block (TAP) Versus Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Laparoscopic Gynecologic Surgeries
A study testing TAP Block Group and M-TAPA Block group in people with Gynecologic Laparoscopic Surgery and Regional Anesthesia Block, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Although laparoscopic techniques are considered minimally invasive surgical procedures with lower perioperative pain scores compared to open surgeries, they are still associated with significant levels of pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Gynecologic Laparoscopic Surgery, Regional Anesthesia Block
- What is being tested?
- TAP Block Group and M-TAPA Block group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
None listed.
Who cannot join
- Neuropathy
- Chronic analgesic therapy
- Severe cardiopulmonary disease
- Uncontrolled diabetes mellitus (HbA1c > 8%)
- Severe renal or hepatic failure
- Pregnancy or lactation
Show all 12Show fewer
- Body mass index (BMI) greater than 35 kg/m²
- Local infection at the injection site
- Inability to comprehend pain scores or cooperate (e.g., Alzheimer's disease, mental retardation)
- Allergy to local anesthetic agents
- Refusal to participate in the study
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, 06010
ela erdem hıdıroglu, +905348874184, drelaerdem@gmail.com
About this study
Although laparoscopic techniques are considered minimally invasive surgical procedures with lower perioperative pain scores compared to open surgeries, they are still associated with significant levels of pain. This study aims to investigate the analgesic effectiveness of two routinely performed regional analgesic techniques in our clinic-ultrasound-guided classic bilateral TAP block and ultrasound-guided bilateral M-TAPA block-in patients undergoing laparoscopic gyneco-oncologic surgery (LGOS), as well as their effects on intraoperative opioid consumption.
- Being tested
- TAP Block Group, M-TAPA Block group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP Block GroupProcedure or surgery
Patients in the TAP group will receive a bilateral Transversus Abdominis Plane (TAP) block under ultrasound guidance prior to surgery after general anaesthesia, with the local anesthetic administered between the internal oblique and transversus abdominis muscles. A total of 40 mL of 0.25% bupivacaine will be used for the procedure.
M-TAPA Block groupProcedure or surgery
Patients in the M-TAPA group will receive a bilateral Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) under ultrasound guidance prior to surgery after general anaesthesia. A total of 40 mL of 0.25% bupivacaine will be used for the procedure.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Not described |
| group TAP | Active comparator | Not described Receives: Procedure: TAP Block Group |
| group M-TAPA | Active comparator | Not described Receives: Procedure: M-TAPA Block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of intraoperative opioid consumption
Measured: during surgery
Secondary outcomes (1)
Comparison of postoperative Visual Analog Scale (VAS) pain scores
VAS is an eleven-scale pain score scored from 0 to 10, with vas 0 being no pain and vas 10 being maximum pain.
Measured: postoperative first day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start30 May 2025 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic Laparoscopic SurgeryStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ela Erdem Hıdiroglu, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995404
- Sponsor's protocol ID
- AESH-EK-2025-028
- Status last verified
- May 2025
- First submitted
- 28 Apr 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane Block (TAP) Versus Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Laparoscopic Gynecologic Surgeries
- ClinicalTrials.gov ID
- NCT06995404
- Acronym / sponsor ID
- AESH-EK-2025-028
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 30 May 2025 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 29 May 2025 (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.
Although laparoscopic techniques are considered minimally invasive surgical procedures with lower perioperative pain scores compared to open surgeries, they are still associated with significant levels of pain. This study aims to investigate the analgesic effectiveness of two routinely performed regional analgesic techniques in our clinic-ultrasound-guided classic bilateral TAP block and ultrasound-guided bilateral M-TAPA block-in patients undergoing laparoscopic gyneco-oncologic surgery (LGOS), as well as their effects on intraoperative opioid consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | – |
| group TAP | Active comparator | Procedure: TAP Block Group |
| group M-TAPA | Active comparator | Procedure: M-TAPA Block group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Neuropathy
- Chronic analgesic therapy
- Severe cardiopulmonary disease
- Uncontrolled diabetes mellitus (HbA1c > 8%)
- Severe renal or hepatic failure
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 |
|---|---|---|
| TAP Block GroupPatients in the TAP group will receive a bilateral Transversus Abdominis Plane (TAP) block under ultrasound guidance prior to surgery after general anaesthesia, with the local anesthetic administered between the internal oblique and transversus abdominis muscles. A total of 40 mL of 0.25% bupivacaine will be used for the procedure. | Procedure or surgery | group TAP |
| M-TAPA Block groupPatients in the M-TAPA group will receive a bilateral Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) under ultrasound guidance prior to surgery after general anaesthesia. A total of 40 mL of 0.25% bupivacaine will be used for the procedure. | Procedure or surgery | group M-TAPA |
Primary outcome
Evaluation of intraoperative opioid consumption
Time frame: during surgery
1 secondary outcome
Comparison of postoperative Visual Analog Scale (VAS) pain scores
Time frame: postoperative first day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP Block Group and M-TAPA Block group in people with Gynecologic Laparoscopic Surgery and Regional Anesthesia Block, 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 0 inclusion and 12 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: opening soon, as of the sponsor's last update on 29 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ELA ERDEM HIDIROGLU (03127970000, drelaerdem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of intraoperative opioid consumption (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2025.