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
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