Pain ManagementpainNCT07311902
M-Tapa Block and Transversus Abdominal Plane Block for Postoperative Analgesia in Unilateral Open Inguinal Hernia Repair Surgery
A study testing TAP Block Group and M TAPA block in people with Pain Management and Mtapa Block, run by Erzurum Regional Training & Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients will be called to the operating room one hour before surgery and no premedication will be applied before coming to the operating room. Patients in both groups who are taken to the block room will be administered 1-2 mg iv midazolam for sedation. M TAPA block will be applied for the surgical procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain Management, Mtapa Block, TAP Block
- What is being tested?
- TAP Block Group and M TAPA block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 Jan 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planning for elective unilateral open inguinal hernia repair surgery
- ASA I-II status
- Being between 18 and 65 years of age
Who cannot join
- History of bleeding diathesis
- Allergy or sensitivity to local anesthetics and opioids
- Infection in the area where the block will be applied
- Alcohol or drug addiction
- Patients with a BMI > 30
- Suspected pregnancy
Show all 10Show fewer
- Women in pregnancy or lactation
- Patients with allergies to study drugs
- Patient refusal
- Use of anticoagulant agents
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, 1 recruiting
- Recruiting
Erzurum Regional Education and Research Hospital
Erzurum, 25000
Erzurum RTRH, +90 ( 442 ) 432 10 00, erzurumsh@saglik.gov.tr
About this study
Official title: Comparison of Patient Satisfaction Survey and Pain Follow-up in Patients Who Underwent M-Tapa Block and Transversus Abdominal Plane Block for Postoperative Analgesia in Unilateral Open Inguinal Hernia Repair Surgery
Patients will be called to the operating room one hour before surgery and no premedication will be applied before coming to the operating room. Patients in both groups who are taken to the block room will be administered 1-2 mg iv midazolam for sedation. M TAPA block will be applied for the surgical procedure. After aseptic conditions are provided, the high-frequency linear US probe will be covered with a sterile sheath. The US probe will be placed in the saggital plane at the costochondral angle where the midclavicular line intersects the costal cartilage. 5 ml of saline will be injected using the in-plane technique using a 22G 100 mm block needle and the block location will be verified. After the block location is verified, a total of 20 ml of 0.25% bupivacaine will be injected unilaterally and the procedure will be terminated. After aseptic conditions are provided, the high-frequency linear US probe will be covered with a sterile sheath. In TAP block, the block needle will be advanced to the fascial plane between the internal oblique and transversus abdominis muscles with the in-plane technique and the procedure will be completed by injecting 5 ml 20 ml 0.25% bupivacaine unilaterally. The same analgesia protocol will be applied to both groups intraoperatively and postoperatively, and a survey will be conducted on the patients at the 24th hour postoperatively.
- Conditions
- Pain Management, Mtapa Block, TAP Block
- Being tested
- TAP Block Group, M TAPA block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP Block GroupProcedure or surgery
20 ml of 0.25% bupivacaine
M TAPA blockProcedure or surgery
20 ml of 0.25% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group T | Active comparator | The block needle will be advanced to the fascial plane between the internal oblique and transversus abdominis muscles by placing the USG transversely on the mid-axillary line between the iliac crest and subcostal planes. 5 ml saline will be injected and the block location will be confirmed. After the block location is confirmed, a total of 20 ml of 0.25% bupivacaine will be injected unilaterally and the procedure will be completed. Receives: Procedure: TAP Block Group |
| Group M | Active comparator | Using the in-plane technique, the probe will be pushed slightly to visualize the lower part of the costochondral angle at the central level, the block needle will be advanced in the caudal-cranio direction, 5 ml of saline will be injected into the layer between the transverse abdominal muscle and the lower plane of the costal cartilage via a 22G 100 mm block needle and the block location will be confirmed. After the block location is confirmed, a total of 20 ml of 0.25% bupivacaine will be injected unilaterally and the procedure will be completed. Receives: Procedure: M TAPA block |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
Patients' pain scores will be evaluated
Measured: The primary aim of our study was to compare VAS scores at 1, 2, 4, 8, 12, and 24 hours postoperatively and to evaluate the level of comfort.
Secondary outcomes (1)
The QoR-15 Patient Questionnaire, a 40-question global recovery rating system with a Turkish variant
To compare patient satisfaction survey and pain monitoring in patients who underwent M-Tapa Block and Transversus Abdominal Plane block for postoperative analgesia in unilateral open inguinal hernia repair surgery and to suggest a more effective method.
Measured: 24 hours following surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Nov 2024
- Primary completion1 Apr 2025
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzurum Regional Training & Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Omer Doymus, Erzurum Regional Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311902
- Sponsor's protocol ID
- B.30.2.YYU.0.01.00.00/93
- Acronym
- pain
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 31 Dec 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 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patient Satisfaction Survey and Pain Follow-up in Patients Who Underwent M-Tapa Block and Transversus Abdominal Plane Block for Postoperative Analgesia in Unilateral Open Inguinal Hernia Repair Surgery
- ClinicalTrials.gov ID
- NCT07311902
- Acronym / sponsor ID
- pain / B.30.2.YYU.0.01.00.00/93
- Conditions
- Pain Management, Mtapa Block, TAP Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Erzurum Regional Training & Research HospitalOther government
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 31 Dec 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.
Patients will be called to the operating room one hour before surgery and no premedication will be applied before coming to the operating room. Patients in both groups who are taken to the block room will be administered 1-2 mg iv midazolam for sedation. M TAPA block will be applied for the surgical procedure. After aseptic conditions are provided, the high-frequency linear US probe will be covered with a sterile sheath. The US probe will be placed in the saggital plane at the costochondral angle where the midclavicular line intersects the costal cartilage. 5 ml of saline will be injected using the in-plane technique using a 22G 100 mm block needle and the block location will be verified. After the block location is verified, a total of 20 ml of 0.25% bupivacaine will be injected unilaterally and the procedure will be terminated. After aseptic conditions are provided, the high-frequency linear US probe will be covered with a sterile sheath. In TAP block, the block needle will be advanced to the fascial plane between the internal oblique and transversus abdominis muscles with the in-plane technique and the procedure will be completed by injecting 5 ml 20 ml 0.25% bupivacaine unilaterally. The same analgesia protocol will be applied to both groups intraoperatively and postoperatively, and a survey will be conducted on the patients at the 24th hour postoperatively.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group T | Active comparator | Procedure: TAP Block GroupThe block needle will be advanced to the fascial plane between the internal oblique and transversus abdominis muscles by placing the USG transversely on the mid-axillary line between the iliac crest and subcostal planes. 5 ml saline will be injected and the block location will be confirmed. After the block location is confirmed, a total of 20 ml of 0.25% bupivacaine will be injected unilaterally and the procedure will be completed. |
| Group M | Active comparator | Procedure: M TAPA blockUsing the in-plane technique, the probe will be pushed slightly to visualize the lower part of the costochondral angle at the central level, the block needle will be advanced in the caudal-cranio direction, 5 ml of saline will be injected into the layer between the transverse abdominal muscle and the lower plane of the costal cartilage via a 22G 100 mm block needle and the block location will be confirmed. After the block location is confirmed, a total of 20 ml of 0.25% bupivacaine will be injected unilaterally and the procedure will be completed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Planning for elective unilateral open inguinal hernia repair surgery
- ASA I-II status
- Being between 18 and 65 years of age
Key exclusion criteria (10 listed)
- History of bleeding diathesis
- Allergy or sensitivity to local anesthetics and opioids
- Infection in the area where the block will be applied
- Alcohol or drug addiction
- Patients with a BMI > 30
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 Group20 ml of 0.25% bupivacaine | Procedure or surgery | Group T |
| M TAPA block20 ml of 0.25% bupivacaine | Procedure or surgery | Group M |
Primary outcome
pain score
Time frame: The primary aim of our study was to compare VAS scores at 1, 2, 4, 8, 12, and 24 hours postoperatively and to evaluate the level of comfort.
Patients' pain scores will be evaluated
1 secondary outcome
The QoR-15 Patient Questionnaire, a 40-question global recovery rating system with a Turkish variant
Time frame: 24 hours following surgery.
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 31 Dec 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 in people with Pain Management and Mtapa Block, run by Erzurum Regional Training & 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 3 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: looking for participants now, as of the sponsor's last update on 31 Dec 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 omer doymus (+905070370397, omerdoymus@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score (time frame: The primary aim of our study was to compare VAS scores at 1, 2, 4, 8, 12, and 24 hours postoperatively and to evaluate the level of comfort.). 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 31 Dec 2025.