Transversus Abdominis Plane Block (TAP Block)NCT07866885
Spinal Anesthesia Versus General Anesthesia Plus TAP Block for Laparoscopic Inguinal Hernia Repair
A study testing General Anesthesia Plus Transversus Abdominis Plane Block and Spinal Anesthesia in people with Transversus Abdominis Plane Block (TAP Block) and Laparoscopic Inguinal Hernia Repair, run by Fatma Cigdem Ozakin at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, double-blind clinical trial compares spinal anesthesia with general anesthesia combined with ultrasound-guided transversus abdominis plane (TAP) block in adult patients undergoing laparoscopic total extraperitoneal (TEP) inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Transversus Abdominis Plane Block (TAP Block), Laparoscopic Inguinal Hernia Repair
- What is being tested?
- General Anesthesia Plus Transversus Abdominis Plane Block and Spinal Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 3 Apr 2027
- 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
- Age >18 and <65 years
- Scheduled for laparoscopic TEP inguinal hernia repair
- Primary inguinal hernia
- No known neuropathy
Who cannot join
- History of previous lower abdominal surgery
- Complicated inguinal hernia, including irreducible, obstructed, or strangulated hernia
- Recurrent inguinal hernia
- Coagulation disorder
- Musculoskeletal deformity
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
Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Istanbul, 34147
Fatma Çiğdem Özakın, MD, +905464168250, f.cigdemulus@gmail.com
Turgut Dönmez, Prof. Dr.
About this study
Official title: Comparison of Spinal Anesthesia and General Anesthesia Plus Transversus Abdominis Plane Block in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair: A Prospective Randomized Double-Blind Clinical Trial
This prospective, randomized, double-blind clinical trial compares spinal anesthesia with general anesthesia combined with ultrasound-guided transversus abdominis plane (TAP) block in adult patients undergoing laparoscopic total extraperitoneal (TEP) inguinal hernia repair. Patients will be randomly assigned to one of two anesthesia groups. The primary outcome is postoperative pain assessed using the Visual Analog Scale (VAS) at 1 hour after surgery. Postoperative pain at additional time points, analgesic requirements, opioid consumption, and postoperative complications will also be evaluated.
- Being tested
- General Anesthesia Plus Transversus Abdominis Plane Block, Spinal Anesthesia
- Keywords
- Laparoscopic Inguinal Hernia Repair, Spinal Anesthesia, General Anesthesia, Transversus Abdominis Plane Block, TAP Block, Postoperative Pain, Visual Analog Scale, Analgesic Consumption, Opioid Consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Anesthesia Plus Transversus Abdominis Plane BlockProcedure or surgery
General anesthesia will be administered according to the institutional standard protocol. Following induction of general anesthesia and before the surgical procedure, an ultrasound-guided TAP block will be performed under sterile conditions using a linear ultrasound probe. The fascial plane between the internal oblique and transversus abdominis muscles will be identified and local anesthetic will be administered according to the study protocol.
Spinal AnesthesiaProcedure or surgery
Spinal anesthesia will be performed in the sitting position using a 25-gauge Quincke spinal needle after sterile preparation. Hyperbaric bupivacaine 0.5% (15 mg) with preservative-free fentanyl (10 µg) will be administered intrathecally according to the study protocol. Conscious sedation will be provided with midazolam, fentanyl, and propofol as required.
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia Plus TAP Block | Experimental | Patients in this group will undergo laparoscopic total extraperitoneal (TEP) inguinal hernia repair under general anesthesia combined with an ultrasound-guided transversus abdominis plane (TAP) block. Receives: Procedure: General Anesthesia Plus Transversus Abdominis Plane Block |
| Spinal Anesthesia | Active comparator | Patients in this group will undergo laparoscopic total extraperitoneal (TEP) inguinal hernia repair under spinal anesthesia. Receives: Procedure: Spinal Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain at 1 Hour
Postoperative pain intensity assessed using the Visual Analog Scale (VAS).
Measured: 1 hour after surgery
Secondary outcomes (2)
Postoperative Pain at 4, 8, and 12 Hours
Postoperative pain intensity assessed using the Visual Analog Scale (VAS).
Measured: 4, 8, and 12 hours after surgery
Postoperative Seroma
Presence of postoperative seroma.
Measured: Within the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Sep 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion3 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transversus Abdominis Plane Block (TAP Block)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants undergoing laparoscopic total extraperitoneal inguinal hernia repair will be randomly assigned to one of two parallel groups: general anesthesia combined with transversus abdominis plane block or spinal anesthesia.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatma Cigdem Ozakin
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Fatma Cigdem Ozakin, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866885
- Sponsor's protocol ID
- 2026-55
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Spinal Anesthesia and General Anesthesia Plus Transversus Abdominis Plane Block in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair: A Prospective Randomized Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT07866885
- Acronym / sponsor ID
- 2026-55
- Keywords
- Laparoscopic Inguinal Hernia Repair, Spinal Anesthesia, General Anesthesia, Transversus Abdominis Plane Block, TAP Block, Postoperative Pain, Visual Analog Scale, Analgesic Consumption
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Fatma Cigdem OzakinOther government
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 3 Apr 2027 (estimated)
- First posted
- 8 Oct 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 prospective, randomized, double-blind clinical trial compares spinal anesthesia with general anesthesia combined with ultrasound-guided transversus abdominis plane (TAP) block in adult patients undergoing laparoscopic total extraperitoneal (TEP) inguinal hernia repair. Patients will be randomly assigned to one of two anesthesia groups. The primary outcome is postoperative pain assessed using the Visual Analog Scale (VAS) at 1 hour after surgery. Postoperative pain at additional time points, analgesic requirements, opioid consumption, and postoperative complications will also be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants undergoing laparoscopic total extraperitoneal inguinal hernia repair will be randomly assigned to one of two parallel groups: general anesthesia combined with transversus abdominis plane block or spinal anesthesia.
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia Plus TAP Block | Experimental | Procedure: General Anesthesia Plus Transversus Abdominis Plane BlockPatients in this group will undergo laparoscopic total extraperitoneal (TEP) inguinal hernia repair under general anesthesia combined with an ultrasound-guided transversus abdominis plane (TAP) block. |
| Spinal Anesthesia | Active comparator | Procedure: Spinal AnesthesiaPatients in this group will undergo laparoscopic total extraperitoneal (TEP) inguinal hernia repair under spinal anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 and <65 years
- Scheduled for laparoscopic TEP inguinal hernia repair
- Primary inguinal hernia
- No known neuropathy
Key exclusion criteria (5 listed)
- History of previous lower abdominal surgery
- Complicated inguinal hernia, including irreducible, obstructed, or strangulated hernia
- Recurrent inguinal hernia
- Coagulation disorder
- Musculoskeletal deformity
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 |
|---|---|---|
| General Anesthesia Plus Transversus Abdominis Plane BlockGeneral anesthesia will be administered according to the institutional standard protocol. Following induction of general anesthesia and before the surgical procedure, an ultrasound-guided TAP block will be performed under sterile conditions using a linear ultrasound probe. The fascial plane between the internal oblique and transversus abdominis muscles will be identified and local anesthetic will be administered according to the study protocol. | Procedure or surgery | General Anesthesia Plus TAP Block |
| Spinal AnesthesiaSpinal anesthesia will be performed in the sitting position using a 25-gauge Quincke spinal needle after sterile preparation. Hyperbaric bupivacaine 0.5% (15 mg) with preservative-free fentanyl (10 µg) will be administered intrathecally according to the study protocol. Conscious sedation will be provided with midazolam, fentanyl, and propofol as required. | Procedure or surgery | Spinal Anesthesia |
Primary outcome
Postoperative Pain at 1 Hour
Time frame: 1 hour after surgery
Postoperative pain intensity assessed using the Visual Analog Scale (VAS).
2 secondary outcomes
Postoperative Pain at 4, 8, and 12 Hours
Time frame: 4, 8, and 12 hours after surgery
Postoperative Seroma
Time frame: Within the first 24 hours after 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 8 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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 General Anesthesia Plus Transversus Abdominis Plane Block and Spinal Anesthesia in people with Transversus Abdominis Plane Block (TAP Block) and Laparoscopic Inguinal Hernia Repair, run by Fatma Cigdem Ozakin 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 4 inclusion and 5 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 8 Oct 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?
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 Fatma Çiğdem Özakın, MD (+905464168250, f.cigdemulus@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain at 1 Hour (time frame: 1 hour after 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 8 Oct 2026.