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
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
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- 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