Inguinal Hernia BilateralNCT07522853
M-TAPA vs OSTAP for Postoperative Analgesia in Laparoscopic Inguinal Hernia
A study testing Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA), Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) and Standard Analgesia use (paracetamol, contramal) in people with Inguinal Hernia Bilateral and Postoperative Pain, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to compare the postoperative analgesic efficacy of M-TAPA block and OSTAP block in patients undergoing laparoscopic inguinal hernia repair. Pain scores, analgesic consumption, and patient satisfaction will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inguinal Hernia Bilateral, Postoperative Pain
- What is being tested?
- Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA), Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) and Standard Analgesia use (paracetamol, contramal)
- 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
- 8 Apr 2025to 20 Sep 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective laparoscopic inguinal hernia repair (TEP technique)
- Ability to understand and use the Visual Analog Scale (VAS)
- Provided written informed consent
Who cannot join
- Refusal to participate or inability to provide informed consent
- Age under 18 or over 65 years
- ASA physical status ≥ III
- Coagulopathy (including abnormal INR, thrombocytopenia, or platelet dysfunction)
- Infection at the injection site
- Known allergy or hypersensitivity to study medications (local anesthetics, NSAIDs, opioids)
Show all 10Show fewer
- Chronic opioid use (longer than 4 weeks)
- Use of psychiatric medications affecting pain perception
- Inability to cooperate or communicate effectively
- Requirement for postoperative intensive care
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kartal Dr. Lütfi Kırdar City Hospital
Istanbul
About this study
Official title: Laparoscopic Inguinal Hernia Surgery Patients: Comparison of Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) and Oblique Subcostal TAP Block for Postoperative Analgesia
This randomized controlled trial aims to compare the postoperative analgesic efficacy of M-TAPA block and OSTAP block in patients undergoing laparoscopic inguinal hernia repair. Pain scores, analgesic consumption, and patient satisfaction will be evaluated.
Read the detailed description
Prospective, randomized, single-blind, controlled study including 90 patients undergoing elective laparoscopic inguinal hernia repair. Patients will be randomized into three groups: M-TAPA, OSTAP, and control. Postoperative pain scores (VAS), analgesic consumption, time to first analgesic requirement, and patient satisfaction will be assessed over 24 hours.
- Conditions
- Inguinal Hernia Bilateral, Postoperative Pain
- Being tested
- Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA), Oblique Subcostal Transversus Abdominis Plane Block (OSTAP), Standard Analgesia use (paracetamol, contramal)
- Keywords
- MTAPA, OSTAP, Postoperative pain, TAP Block, VAS Score
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA)Procedure or surgery
Ultrasound-guided bilateral M-TAPA block performed with 20 mL of 0.25% bupivacaine per side
Oblique Subcostal Transversus Abdominis Plane Block (OSTAP)Procedure or surgery
Ultrasound-guided bilateral OSTAP block performed with 20 mL of 0.25% bupivacaine per side
Standard Analgesia use (paracetamol, contramal)Other
Patients received standard postoperative analgesia without regional block
| Study group | Role | What they receive |
|---|---|---|
| M-TAPA | Experimental | Bilateral M-TAPA block applied after surgery Receives: Procedure: Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) |
| OSTAP | Experimental | Bilateral OSTAP block applied after surgery Receives: Procedure: Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) |
| CONTROL | Other | No block applied and standart analgesia procedure Receives: Other: Standard Analgesia use (paracetamol, contramal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total analgesic consumption in 24 hours
Total amount of dexketoprofen consumed in the first 24 hours after surgery
Measured: 24 hours postoperative
Secondary outcomes (5)
Postoperative Pain Intensity (VAS Score)
Postoperative pain intensity assessed using the Visual Analog Scale (VAS, 0-10), where 0 indicates no pain and 10 indicates worst imaginable pain.
Measured: 0 (15 minutes), 2, 4, 8, 12, 16, and 24 hours postoperative
Time to First Analgesic Requirement
Time from the end of surgery to the first request for analgesic medication
Measured: Within 24 hours postoperative
Tramadol Consumption
Total amount of tramadol administered within the first 24 hours after surgery.
Measured: 24 hours postoperative
Patient Satisfaction Score
Patient satisfaction assessed using a Likert scale evaluating overall satisfaction with postoperative pain management
Measured: 24 hours postoperative
Incidence of Postoperative Nausea and Vomiting
Incidence of nausea and vomiting observed during the first 24 hours after surgery.
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start8 Apr 2025
- Primary completion20 Sep 2025
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia BilateralStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emre Yilmaz, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Investigators
- Tahsin Simsek, MD, Principal investigator, Dr. Lutfi Kirdar Kartal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522853
- Sponsor's protocol ID
- 2025-KAEK-43
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to patient confidentiality, ethical considerations, and institutional regulations.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Inguinal Hernia Surgery Patients: Comparison of Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) and Oblique Subcostal TAP Block for Postoperative Analgesia
- ClinicalTrials.gov ID
- NCT07522853
- Acronym / sponsor ID
- 2025-KAEK-43
- Conditions
- Inguinal Hernia Bilateral, Postoperative Pain
- Keywords
- MTAPA, OSTAP, Postoperative pain, TAP Block, VAS Score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 13 Apr 2026 (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.
This randomized controlled trial aims to compare the postoperative analgesic efficacy of M-TAPA block and OSTAP block in patients undergoing laparoscopic inguinal hernia repair. Pain scores, analgesic consumption, and patient satisfaction will be evaluated.
Detailed description
Prospective, randomized, single-blind, controlled study including 90 patients undergoing elective laparoscopic inguinal hernia repair. Patients will be randomized into three groups: M-TAPA, OSTAP, and control. Postoperative pain scores (VAS), analgesic consumption, time to first analgesic requirement, and patient satisfaction will be assessed over 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| M-TAPA | Experimental | Procedure: Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA)Bilateral M-TAPA block applied after surgery |
| OSTAP | Experimental | Procedure: Oblique Subcostal Transversus Abdominis Plane Block (OSTAP)Bilateral OSTAP block applied after surgery |
| CONTROL | Other | Other: Standard Analgesia use (paracetamol, contramal)No block applied and standart analgesia procedure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged between 18 and 65 years
- American Society of Anesthesiologists (ASA) physical status I-II
- Scheduled for elective laparoscopic inguinal hernia repair (TEP technique)
- Ability to understand and use the Visual Analog Scale (VAS)
- Provided written informed consent
Key exclusion criteria (10 listed)
- Refusal to participate or inability to provide informed consent
- Age under 18 or over 65 years
- ASA physical status ≥ III
- Coagulopathy (including abnormal INR, thrombocytopenia, or platelet dysfunction)
- Infection at the injection site
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 |
|---|---|---|
| Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA)Ultrasound-guided bilateral M-TAPA block performed with 20 mL of 0.25% bupivacaine per side | Procedure or surgery | M-TAPA |
| Oblique Subcostal Transversus Abdominis Plane Block (OSTAP)Ultrasound-guided bilateral OSTAP block performed with 20 mL of 0.25% bupivacaine per side | Procedure or surgery | OSTAP |
| Standard Analgesia use (paracetamol, contramal)Patients received standard postoperative analgesia without regional block | Other | CONTROL |
Primary outcome
Total analgesic consumption in 24 hours
Time frame: 24 hours postoperative
Total amount of dexketoprofen consumed in the first 24 hours after surgery
5 secondary outcomes
Postoperative Pain Intensity (VAS Score)
Time frame: 0 (15 minutes), 2, 4, 8, 12, 16, and 24 hours postoperative
Time to First Analgesic Requirement
Time frame: Within 24 hours postoperative
Tramadol Consumption
Time frame: 24 hours postoperative
Patient Satisfaction Score
Time frame: 24 hours postoperative
Incidence of Postoperative Nausea and Vomiting
Time frame: 24 hours postoperative
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 13 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to patient confidentiality, ethical considerations, and institutional regulations.
Related trials for Inguinal Hernia Bilateral
Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Recruiting
Ultrasound-guided Quadratus Lumborum Block Versus Erector Spinae Plane Block for Postoperative Analgesia in Children Undergoing Elective Open Lower Abdominal Surgeries
Bilateral Inguinal Hernia Repair, Open Upper Abdominal Surgeries
RecruitingPhase 1
Reversing InGuinal Hernia Trial: The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males
Inguinal Hernia Unilateral, Inguinal Hernia Bilateral
Not yet recruiting
Bilateral vs Unilateral Inguinal Hernia Repairs With an Asymptomatic Inguinal Hernia in Bilateral Hernias
Inguinal Hernia Bilateral
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.
Tahsin Simsek, MD principal investigator
Dr. Lutfi Kirdar Kartal Training and Research 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 Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA), Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) and Standard Analgesia use (paracetamol, contramal) in people with Inguinal Hernia Bilateral and Postoperative Pain, run by Dr. Lutfi Kirdar Kartal Training and Research 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 5 inclusion and 10 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 13 Apr 2026. 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?
Total analgesic consumption in 24 hours (time frame: 24 hours postoperative). 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 13 Apr 2026.