Back to resultsTAP Block and Subacute Pain in Inguinal Herniography
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transversus abdominis plane block
Tramadol and paracetamol
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Pain focused on measuring TAP block, subacute pain, inguinal herniography
Eligibility Criteria
Inclusion Criteria:
- ASA I-III
- who were to undergo elective unilateral inguinal herniography with "mesh" under general anesthesia.
Exclusion Criteria:
- patients who have allergy to local anesthetics
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Tramadol and paracetamol
transversus abdominis plane block
Arm Description
subjects were administered intravenous analgesia (control group) Tramadol 100 mg and paracetamol 1000 mg at the end of the surgery
patients that applied transversus abdominis plane block at the end of the surgery after given intravenous analgesia
Outcomes
Primary Outcome Measures
verbal numeric scale
patients were questioned for pain graduation to give a point from 0 to 10 according to the intensity of the pain. 0 equals to no pain, 10 equals to the strongest pain
Secondary Outcome Measures
verbal numeric scale
according to the intensity of the pain. 0 equals to no pain, 10 equals to the strongest pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02914028
Brief Title
TAP Block and Subacute Pain in Inguinal Herniography
Official Title
Evaluation of the Effects of Subcostal Transversus Abdominis Plane Block on Subacute Pain Development Following Inguinal Herniography: a Randomized Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Inguinal hernia repair with mesh has a high incidence of postoperative chronic pain. Transversus abdominis plane block is a current intervention to support postoperative analgesia, however it is recently in research area how to be applied in different surgical areas to be more effective than intravenous opioids. Subcostal transversus abdominis plane block is not advised but has not been studied to be effective for postoperative analgesia in inguinal herniography patients.
This study aims to research the effect of subcostal transversus abdominis plane block in subacute postoperative pain after inguinal hernia repair
Detailed Description
Patients were divided into two groups, one is control and the second is subcostal transversus abdominis plane block (STAP) group. After standard general anesthesia application, control group ( Group I) had 1 gram of paracetamol and 100 mg of contramal just after starting surgical closure. Group II (STAP) had 1 gram of paracetamol and 100 mg of contramal, after surgical closure transversus abdominis plane block in subcostal area was applied to the patient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
TAP block, subacute pain, inguinal herniography
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tramadol and paracetamol
Arm Type
Active Comparator
Arm Description
subjects were administered intravenous analgesia (control group) Tramadol 100 mg and paracetamol 1000 mg at the end of the surgery
Arm Title
transversus abdominis plane block
Arm Type
Active Comparator
Arm Description
patients that applied transversus abdominis plane block at the end of the surgery after given intravenous analgesia
Intervention Type
Procedure
Intervention Name(s)
transversus abdominis plane block
Other Intervention Name(s)
stimuplex A
Intervention Description
A peripheric block needle is inserted entering the facia between musculus rectus abdominis and musculus transversus abdominis with ultrasonography and local anesthetics are injected in the facia.
Intervention Type
Drug
Intervention Name(s)
Tramadol and paracetamol
Other Intervention Name(s)
contramal, parol infusion solution
Intervention Description
Tramadol 100 mg and paracetamol 1000 mg are applied to the patients at the end of the surgery
Primary Outcome Measure Information:
Title
verbal numeric scale
Description
patients were questioned for pain graduation to give a point from 0 to 10 according to the intensity of the pain. 0 equals to no pain, 10 equals to the strongest pain
Time Frame
1 month after the operation
Secondary Outcome Measure Information:
Title
verbal numeric scale
Description
according to the intensity of the pain. 0 equals to no pain, 10 equals to the strongest pain
Time Frame
15 minutes, 1-6-12-24 hours and 15 days after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ASA I-III
who were to undergo elective unilateral inguinal herniography with "mesh" under general anesthesia.
Exclusion Criteria:
patients who have allergy to local anesthetics
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TAP Block and Subacute Pain in Inguinal Herniography
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