Transversus Abdominis Plane(TAP) Block, Local Infiltration and Intravenous Dexketoprofen in Inguinal Hernia Repair (Analgesia)
Primary Purpose
Inguinal Hernia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transversus abdominis plane block
Local anesthetic infiltration
Intravenous dexketoprofen
Sponsored by
About this trial
This is an interventional supportive care trial for Inguinal Hernia
Eligibility Criteria
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
Sites / Locations
- University of Health Sciences Gazi Yaşargil Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group TAP
Group Local
Group Dexketoprofen
Arm Description
Ultrasound-guided TAP Block
Ultrasound-guided Local Infiltration
Intravenous Dexketoprofen
Outcomes
Primary Outcome Measures
Postoperative rescue tramadol consumption
The mean tramadol consumption in the first 24 post-operative hours
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT04227912
First Posted
January 8, 2020
Last Updated
January 10, 2020
Sponsor
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04227912
Brief Title
Transversus Abdominis Plane(TAP) Block, Local Infiltration and Intravenous Dexketoprofen in Inguinal Hernia Repair
Acronym
Analgesia
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group TAP
Arm Type
Active Comparator
Arm Description
Ultrasound-guided TAP Block
Arm Title
Group Local
Arm Type
Active Comparator
Arm Description
Ultrasound-guided Local Infiltration
Arm Title
Group Dexketoprofen
Arm Type
Active Comparator
Arm Description
Intravenous Dexketoprofen
Intervention Type
Other
Intervention Name(s)
Transversus abdominis plane block
Intervention Description
Before surgery, Ultrasound-guided TAP block was performed preemptively to Group TAP patients.
Intervention Type
Other
Intervention Name(s)
Local anesthetic infiltration
Intervention Description
Before surgery, Ultrasound-guided Local anesthetic infiltration to the surgical incision line was performed preemptively to Group Local patients.
Intervention Type
Other
Intervention Name(s)
Intravenous dexketoprofen
Intervention Description
Before surgery, 50 mg intravenous dexketoprofen was performed preemptively to Group dexketoprofen patients.
Primary Outcome Measure Information:
Title
Postoperative rescue tramadol consumption
Description
The mean tramadol consumption in the first 24 post-operative hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Analgesic efficacy
Description
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
Title
Postoperative nausea-vomiting
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fikret Salık
Organizational Affiliation
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Health Sciences Gazi Yaşargil Training and Research Hospital
City
Di̇yarbakir
State/Province
Eyalet/Yerleşke
ZIP/Postal Code
21070
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
21928388
Citation
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.
Results Reference
result
PubMed Identifier
23549122
Citation
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.
Results Reference
result
Links:
URL
https://insights.ovid.com/
Description
European Journal of Anaesthesiology
Learn more about this trial
Transversus Abdominis Plane(TAP) Block, Local Infiltration and Intravenous Dexketoprofen in Inguinal Hernia Repair
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