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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05172882
• Other study ID #: ATATÜRK ÜNIVERSITESI
• Status: Completed
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: November 2022
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Erkan Cem ÇELIK	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores (0 (low)-10 (high))	Pain will be assessed by visual analog scale scores	1st hour
Primary	Pain Scores (0 (low)-10 (high))	Pain will be assessed by visual analog scale scores	2nd hour
Primary	Pain Scores (0 (low)-10 (high))	Pain will be assessed by visual analog scale scores	4th hour
Primary	Pain Scores (0 (low)-10 (high))	Pain will be assessed by visual analog scale scores	8th hour
Primary	Pain Scores (0 (low)-10 (high))	Pain will be assessed by visual analog scale scores	12th hour
Primary	Pain Scores (0 (low)-10 (high))	Pain will be assessed by visual analog scale scores	24th hour
Secondary	Rescue analgesic consumption	Analgesic drug consumption will be assessed	Any time on postsurgical first 24 hour.