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Completed

NCT Number: NCT04227912

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Gazi Yaşargil Training and Research Hospital

Diyarbakır, Eyalet/Yerleşke, 21070, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Transversus abdominis plane block

Other

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

Local anesthetic infiltration

Other

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

Intravenous dexketoprofen

Other

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

Primary outcomes

  1. Postoperative rescue tramadol consumption

    Time frame: 24 hours

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

Secondary outcomes

  1. Analgesic efficacy

    Time frame: 24 hours

    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

  2. Postoperative nausea-vomiting

    Time frame: 24 hours

    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.

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Official study title

Comparison of Postoperative Analgesic Efficacy of Preemptive Ultrasound-guided Transversus Abdominis Plane Block, Ultrasound-guided Local Infiltration and Intravenous Dexketoprofen in Inguinal Hernia Repair

Acronym: Analgesia

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 14, 2020
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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