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

January 10, 2020 updated by: Fikret Salık, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Comparison of Postoperative Analgesic Efficacy of Preemptive Ultrasound-guided Transversus Abdominis Plane Block, Ultrasound-guided 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group TAP
Ultrasound-guided TAP Block
Other: Transversus abdominis plane block
Before surgery, Ultrasound-guided TAP block was performed preemptively to Group TAP patients.
Active Comparator: Group Local
Ultrasound-guided Local Infiltration
Other: Local anesthetic infiltration
Before surgery, Ultrasound-guided Local anesthetic infiltration to the surgical incision line was performed preemptively to Group Local patients.
Active Comparator: Group Dexketoprofen
Intravenous Dexketoprofen
Other: Intravenous dexketoprofen
Before surgery, 50 mg intravenous dexketoprofen was performed preemptively to Group dexketoprofen patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative rescue tramadol consumption
Time Frame: 24 hours
The mean tramadol consumption in the first 24 post-operative hours
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Investigators

  • Principal Investigator: Fikret Salık, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2019

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 14, 2020

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 10, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBUGaziYasargilTRH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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