Back to resultsEfficacy of Transversalis Fascia Plane Block Versus Wound Infiltration in Varicoselectomy Surgery
Primary Purpose
Analgesia, Transversalis Fascia Plane Block, Wound Infiltration
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Wound site infiltration
Transversalis fascia plane block
Sponsored by
About this trial
This is an interventional treatment trial for Analgesia
Eligibility Criteria
Inclusion Criteria:
- Patients over the age of 18 who will undergo Varicocele operation
- ASA I-II
Exclusion Criteria:
- Patients with allergic reaction to anesthesia and analgesia drugs to be used
- Patients who did not want to voluntarily participate in the study
- Severe systemic disease (kidney, liver, pulmonary, endocrine)
- Substance abuse history
- Chronic pain history
- Psychiatric problems and communication difficulties
- History of hematological problem
- Patients with severe hemodynamic instability due to infection, heavy bleeding
Sites / Locations
- Erkan Cem ÇELİK
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Wound Infiltration
Transversalis Fascia Plane Block
Arm Description
Wound infiltration will be applied to the surgical incision site for patients in this group. Infiltration fluid will contain 20 ml 0.25% bupivakain.
Transversalis fascia plane block will be performed on only one periinguinal side for patients in this group. Block fluid will contain 20 ml 0.25% bupivakain.
Outcomes
Primary Outcome Measures
Pain Scores (0 (low)-10 (high))
Pain will be assessed by visual analog scale scores
Pain Scores (0 (low)-10 (high))
Pain will be assessed by visual analog scale scores
Pain Scores (0 (low)-10 (high))
Pain will be assessed by visual analog scale scores
Pain Scores (0 (low)-10 (high))
Pain will be assessed by visual analog scale scores
Pain Scores (0 (low)-10 (high))
Pain will be assessed by visual analog scale scores
Pain Scores (0 (low)-10 (high))
Pain will be assessed by visual analog scale scores
Secondary Outcome Measures
Rescue analgesic consumption
Analgesic drug consumption will be assessed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05172882
Brief Title
Efficacy of Transversalis Fascia Plane Block Versus Wound Infiltration in Varicoselectomy Surgery
Official Title
Comparison of the Efficacy of Transversalis Fascia Plane Block and Wound Infiltration in Varicoselectomy Surgery; Randomised, Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
April 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Before surgery, patients will be divided into 2 groups as transversalis fascia plane block will be applied and skin infiltration will be applied. Post-operative analgesic procedures will be applied to patients receiving general anesthesia. Postoperative analgesic consumption and pain scores of the patients will be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Transversalis Fascia Plane Block, Wound Infiltration, Varicoselectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Wound Infiltration
Arm Type
Experimental
Arm Description
Wound infiltration will be applied to the surgical incision site for patients in this group. Infiltration fluid will contain 20 ml 0.25% bupivakain.
Arm Title
Transversalis Fascia Plane Block
Arm Type
Experimental
Arm Description
Transversalis fascia plane block will be performed on only one periinguinal side for patients in this group. Block fluid will contain 20 ml 0.25% bupivakain.
Intervention Type
Procedure
Intervention Name(s)
Wound site infiltration
Intervention Description
Block fluids that were prepared as 20 ml 0.25% bupivacaine before the intervention, will be applied through the upper and lower incision lips on the suprainguinal surgical site.
Intervention Type
Procedure
Intervention Name(s)
Transversalis fascia plane block
Intervention Description
External, internal oblique, and transversus abdominis muscles will be visualized by the ultrasound device. After transversalis fascia will be seen, transversalis fascia plane block will be performed. As a block fluid 20 ml 0.25% bupivacaine will be applied.
Primary Outcome Measure Information:
Title
Pain Scores (0 (low)-10 (high))
Description
Pain will be assessed by visual analog scale scores
Time Frame
1st hour
Title
Pain Scores (0 (low)-10 (high))
Description
Pain will be assessed by visual analog scale scores
Time Frame
2nd hour
Title
Pain Scores (0 (low)-10 (high))
Description
Pain will be assessed by visual analog scale scores
Time Frame
4th hour
Title
Pain Scores (0 (low)-10 (high))
Description
Pain will be assessed by visual analog scale scores
Time Frame
8th hour
Title
Pain Scores (0 (low)-10 (high))
Description
Pain will be assessed by visual analog scale scores
Time Frame
12th hour
Title
Pain Scores (0 (low)-10 (high))
Description
Pain will be assessed by visual analog scale scores
Time Frame
24th hour
Secondary Outcome Measure Information:
Title
Rescue analgesic consumption
Description
Analgesic drug consumption will be assessed
Time Frame
Any time on postsurgical first 24 hour.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over the age of 18 who will undergo Varicocele operation
ASA I-II
Exclusion Criteria:
Patients with allergic reaction to anesthesia and analgesia drugs to be used
Patients who did not want to voluntarily participate in the study
Severe systemic disease (kidney, liver, pulmonary, endocrine)
Substance abuse history
Chronic pain history
Psychiatric problems and communication difficulties
History of hematological problem
Patients with severe hemodynamic instability due to infection, heavy bleeding
Facility Information:
Facility Name
Erkan Cem ÇELİK
City
Erzurum
ZIP/Postal Code
25080
Country
Turkey
12. IPD Sharing Statement
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Efficacy of Transversalis Fascia Plane Block Versus Wound Infiltration in Varicoselectomy Surgery
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