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

Sponsor

Ataturk University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05172882

Collaborator

(none)

Enrollment

Location

Arms

3.9

Anticipated Duration (Months)

15.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia Transversalis Fascia Plane Block Wound Infiltration Varicoselectomy	Procedure: Wound site infiltration Procedure: Transversalis fascia plane block	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 15, 2021

Anticipated Primary Completion Date :

Mar 15, 2022

Anticipated Study Completion Date :

Mar 15, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Pain Scores (0 (low)-10 (high)) [1st hour]
Pain will be assessed by visual analog scale scores
Pain Scores (0 (low)-10 (high)) [2nd hour]
Pain will be assessed by visual analog scale scores
Pain Scores (0 (low)-10 (high)) [4th hour]
Pain will be assessed by visual analog scale scores
Pain Scores (0 (low)-10 (high)) [8th hour]
Pain will be assessed by visual analog scale scores
Pain Scores (0 (low)-10 (high)) [12th hour]
Pain will be assessed by visual analog scale scores
Pain Scores (0 (low)-10 (high)) [24th hour]
Pain will be assessed by visual analog scale scores

Secondary Outcome Measures

Rescue analgesic consumption [Any time on postsurgical first 24 hour.]
Analgesic drug consumption will be assessed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erkan Cem ÇELİK	Erzurum		Turkey	25080

Sponsors and Collaborators

Ataturk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Erkan Cem ÇELİK, Associate Professor, Ataturk University

ClinicalTrials.gov Identifier:

NCT05172882

Other Study ID Numbers:

ATATÜRK ÜNİVERSİTESİ

First Posted:

Dec 29, 2021

Last Update Posted:

Dec 29, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Wounds and Injuries

Study Results

No Results Posted as of Dec 29, 2021