CClinicalTrials.gg
CompletedNCT04227912AnalgesiaUpdated Jan 14, 2020

Transversus Abdominis Plane(TAP) Block, Local Infiltration and Intravenous Dexketoprofen in Inguinal Hernia Repair

An interventional study of Transversus abdominis plane block and Local anesthetic infiltration in Inguinal Hernia, sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-01-14.

Sponsored by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Feb 2019, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study evaluates the compare the effects of ultrasound guided TAP block, local anesthetic infiltration to the incision line and intravenous dexketoprofen on postoperative analgesic efficacy and rescue tramadol consumption in inguinal hernia repairs.

Read the detailed description

Currently, multimodal techniques are used in inguinal hernia repairs in addition to pharmacological and regional techniques for postoperative analgesia.TAP block is performed on the principle of hydrodissection of the fascia between the internal oblique and transversus abdominis muscles of the abdominal wall muscles with local anesthetic drugs. Local anesthetic drugs provide analgesic effect up to 24 hours in the postoperative period by blocking the T6-L1 nerves in the facial plane. Local anesthetic infiltration which is one of the regional anesthetic techniques, is another method of postoperative analgesia. intravenous analgesic drug is also used as pharmacological postoperative analgesia method in most clinics.

02

Conditions studied

  • Inguinal Hernia
03

In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's enrollment of 120 is above the median of 80 across 739 interventional studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital is the lead sponsor of 56 studies on the registry; 25 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subject who aged 18-75 years
  • American Society of Anesthesiologist (ASA) I-III
  • Subject undergoing unilateral or bilateral inguinal hernia repair

Exclusion criteria

Exclusion Criteria:

  • Subject under 18 and over 75 years of age
  • ASA IV
  • History of allergy to agents
  • Analgesic drug use in the last 48 hours
  • Morbid obese (BMI> 35)
  • Confusion
  • Coagulopathy
  • Local infection at the injection site
  • Subject with heart, lung, hematologic, metabolic and endocrine disease
  • Subject who did not want to be included in the study
  • Subject who refused the spinal anesthesia
  • Subject who failed the spinal anesthesia
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Group TAP

    Ultrasound-guided TAP Block

    Other: Transversus abdominis plane block

  • Active comparator
    Group Local

    Ultrasound-guided Local Infiltration

    Other: Local anesthetic infiltration

  • Active comparator
    Group Dexketoprofen

    Intravenous Dexketoprofen

    Other: Intravenous dexketoprofen

Interventions

  • OtherTransversus abdominis plane block

    Before surgery, Ultrasound-guided TAP block was performed preemptively to Group TAP patients.

  • OtherLocal anesthetic infiltration

    Before surgery, Ultrasound-guided Local anesthetic infiltration to the surgical incision line was performed preemptively to Group Local patients.

  • OtherIntravenous dexketoprofen

    Before surgery, 50 mg intravenous dexketoprofen was performed preemptively to Group dexketoprofen patients.

06

What researchers measure

Primary outcomes

  1. Postoperative rescue tramadol consumption

    The mean tramadol consumption in the first 24 post-operative hours

    Time frame: 24 hours

Secondary outcomes

  1. Analgesic efficacy

    Postoperative visual analog scale score recorded 0-10 (0 = no pain, 10 = severe pain) at 30. min, 1, 2, 4, 8, 12, 16 and 24 hours postoperatively

    Time frame: 24 hours

  2. Postoperative nausea-vomiting

    Postoperative nausea-vomiting was evaluated with a 3-point system (0: no nausea and vomiting, 1: nausea, but no vomiting, 2: nausea with or without nausea) 24 hours postoperatively.

    Time frame: 24 hours

07

Study locations

1 site
  • University of Health Sciences Gazi Yaşargil Training and Research Hospital
    Di̇yarbakir, Eyalet/Yerleşke 21070, Turkey
08

References and documents

Publications

  • Joshi GP, Rawal N, Kehlet H; PROSPECT collaboration; Bonnet F, Camu F, Fischer HB, Neugebauer EA, Schug SA, Simanski CJ. Evidence-based management of postoperative pain in adults undergoing open inguinal hernia surgery. Br J Surg. 2012 Feb;99(2):168-85. doi: 10.1002/bjs.7660. Epub 2011 Sep 16. PubMed 21928388 ↗
  • Petersen PL, Mathiesen O, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB. The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical trial. Eur J Anaesthesiol. 2013 Jul;30(7):415-21. doi: 10.1097/EJA.0b013e32835fc86f. PubMed 23549122 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04227912
Lead sponsor
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Responsible party
Fikret Salık (Assistant Professor, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital) — Principal investigator
First posted
Jan 14, 2020
Start date
Feb 11, 2019
Primary completion
Oct 1, 2019
Completion
Oct 1, 2019
Last update
Jan 14, 2020

Study contacts

Fikret Salık
principal investigator · Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Oversight

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

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion