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RecruitingNCT07866885Updated Oct 8, 2026

Spinal Anesthesia Versus General Anesthesia Plus TAP Block for Laparoscopic Inguinal Hernia Repair

An interventional study of General Anesthesia Plus Transversus Abdominis Plane Block and Spinal Anesthesia in Transversus Abdominis Plane Block (TAP Block) and Laparoscopic Inguinal Hernia Repair, sponsored by Fatma Cigdem Ozakin. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Fatma Cigdem Ozakin · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Transversus Abdominis Plane Block (TAP Block)
  • Laparoscopic Inguinal Hernia Repair

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Keywords

  • Laparoscopic Inguinal Hernia Repair
  • Spinal Anesthesia
  • General Anesthesia
  • Transversus Abdominis Plane Block
  • TAP Block
  • Postoperative Pain
  • Visual Analog Scale
  • Analgesic Consumption
  • Opioid Consumption
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 70 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Fatma Cigdem Ozakin is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age >18 and \<65 years
  • Scheduled for laparoscopic TEP inguinal hernia repair
  • Primary inguinal hernia
  • No known neuropathy

Exclusion criteria

Exclusion Criteria

  • History of previous lower abdominal surgery
  • Complicated inguinal hernia, including irreducible, obstructed, or strangulated hernia
  • Recurrent inguinal hernia
  • Coagulation disorder
  • Musculoskeletal deformity
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    General Anesthesia Plus TAP Block

    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.

    Procedure: General Anesthesia Plus Transversus Abdominis Plane Block

  • Active comparator
    Spinal Anesthesia

    Patients in this group will undergo laparoscopic total extraperitoneal (TEP) inguinal hernia repair under spinal anesthesia.

    Procedure: Spinal Anesthesia

Interventions

  • ProcedureGeneral Anesthesia Plus Transversus Abdominis Plane Block

    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.

  • ProcedureSpinal Anesthesia

    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.

06

What researchers measure

Primary outcomes

  1. Postoperative Pain at 1 Hour

    Postoperative pain intensity assessed using the Visual Analog Scale (VAS).

    Time frame: 1 hour after surgery

Secondary outcomes

  1. Postoperative Pain at 4, 8, and 12 Hours

    Postoperative pain intensity assessed using the Visual Analog Scale (VAS).

    Time frame: 4, 8, and 12 hours after surgery

  2. Postoperative Seroma

    Presence of postoperative seroma.

    Time frame: Within the first 24 hours after surgery

07

Study locations

1 of 1 sites recruiting
  • Bakırköy Dr. Sadi Konuk Training and Research Hospital
    Istanbul, Istanbul 34147, Turkey (Türkiye)
    • Fatma Çiğdem Özakın, MD · Contact · f.cigdemulus@gmail.com · +905464168250
    • Turgut Dönmez, Prof. Dr. · Principal investigator
    • Fidan Aygün, MD · Sub investigator
    • Okan Can Aksoy, MD · Sub investigator
    • Fatma Çiğdem Özakın, MD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07866885
Lead sponsor
Fatma Cigdem Ozakin
Responsible party
Fatma Cigdem Ozakin (MD, Bakirkoy Dr. Sadi Konuk Research and Training Hospital) — Sponsor-investigator
First posted
Oct 8, 2026
Start date
Sep 1, 2026
Primary completion
Apr 1, 2027 (estimated)
Completion
Apr 3, 2027 (estimated)
Last update
Oct 8, 2026

Study contacts

Fatma Çiğdem Özakın, MD
Contact
f.cigdemulus@gmail.com
+905464168250

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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