NCT05172882

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

November 23, 2021

Last Update Submit

November 8, 2022

Conditions

AnalgesiaTransversalis Fascia Plane BlockWound InfiltrationVaricoselectomy

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (1)

  • Rescue analgesic consumption

    Any time on postsurgical first 24 hour.

Study Arms (2)

Wound Infiltration

EXPERIMENTAL

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

Transversalis Fascia Plane Block

EXPERIMENTAL

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

Interventions

Wound site infiltrationPROCEDURE

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.

Wound Infiltration
Transversalis fascia plane blockPROCEDURE

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.

Transversalis Fascia Plane Block

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over the age of 18 who will undergo Varicocele operation
  • ASA I-II

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erkan Cem ÇELİK

Erzurum, 25080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 23, 2021

First Posted

December 29, 2021

Study Start

November 15, 2021

Primary Completion

March 15, 2022

Study Completion

April 15, 2022

Last Updated

November 9, 2022

Record last verified: 2022-11

Locations

TU(1)