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OpenTrials
Completed

NCT Number: NCT05172882

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

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.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Transversalis Fascia Plane Block Varicoselectomy Wound Infiltration

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Erkan Cem ÇELİK

Erzurum, 25080, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wound Site Infiltration

Procedure

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

Procedure

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 outcomes

  1. Pain Scores (0 (low)-10 (high))

    Time frame: 1st hour

    Pain will be assessed by visual analog scale scores

  2. Pain Scores (0 (low)-10 (high))

    Time frame: 2nd hour

    Pain will be assessed by visual analog scale scores

  3. Pain Scores (0 (low)-10 (high))

    Time frame: 4th hour

    Pain will be assessed by visual analog scale scores

  4. Pain Scores (0 (low)-10 (high))

    Time frame: 8th hour

    Pain will be assessed by visual analog scale scores

  5. Pain Scores (0 (low)-10 (high))

    Time frame: 12th hour

    Pain will be assessed by visual analog scale scores

  6. Pain Scores (0 (low)-10 (high))

    Time frame: 24th hour

    Pain will be assessed by visual analog scale scores

Secondary outcomes

  1. Rescue analgesic consumption

    Time frame: Any time on postsurgical first 24 hour.

    Analgesic drug consumption will be assessed

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 29, 2021
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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