Efficacy of Transversalis Fascia Plane Block Versus Wound Infiltration in Varicoselectomy Surgery

Comparison of the Efficacy of Transversalis Fascia Plane Block and Wound Infiltration in Varicoselectomy Surgery; Randomised, Controlled Study.

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Transversalis Fascia Plane Block; Wound Infiltration; Varicoselectomy
• Intervention / Treatment: Procedure: Wound site infiltration; Procedure: Transversalis fascia plane block

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey, 25080
    • Erkan Cem ÇELİK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wound Infiltration; Wound infiltration will be applied to the surgical incision site for patients in this group. Infiltration fluid will contain 20 ml 0.25% bupivakain.	Procedure: Wound site infiltration; 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.
Experimental: Transversalis Fascia Plane Block; 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.	Procedure: Transversalis fascia plane block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores (0 (low)-10 (high))	Pain will be assessed by visual analog scale scores	1st hour
Pain Scores (0 (low)-10 (high))	Pain will be assessed by visual analog scale scores	2nd hour
Pain Scores (0 (low)-10 (high))	Pain will be assessed by visual analog scale scores	4th hour
Pain Scores (0 (low)-10 (high))	Pain will be assessed by visual analog scale scores	8th hour
Pain Scores (0 (low)-10 (high))	Pain will be assessed by visual analog scale scores	12th hour
Pain Scores (0 (low)-10 (high))	Pain will be assessed by visual analog scale scores	24th hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rescue analgesic consumption	Analgesic drug consumption will be assessed	Any time on postsurgical first 24 hour.

Collaborators and Investigators

• Sponsor: Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): April 15, 2022

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: ATATÜRK ÜNİVERSİTESİ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No