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

ConditionsTransversus Abdominis Plane Block (TAP Block)Laparoscopic Inguinal Hernia Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFatma Cigdem Ozakin

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 and <65 years

Scheduled for laparoscopic TEP inguinal hernia repair

Primary inguinal hernia

No known neuropathy

Disqualifiers

History of previous lower abdominal surgery

Complicated inguinal hernia, including irreducible, obstructed, or strangulated hernia

Recurrent inguinal hernia

Coagulation disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • General Anesthesia Plus Transversus Abdominis Plane Block

    Procedure/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 Anesthesia

    Procedure/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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: General Anesthesia Plus TAP BlockExperimental treatment 1 intervention
Group B: Spinal AnesthesiaActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fatma Cigdem Ozakin

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Sponsor institution

Source ClinicalTrials.gov
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