Transversus Abdominis Plane Block for Chronic Postsurgical Orchalgia
1 other identifier
interventional
70
1 country
1
Brief Summary
the study will evaluate the effect of transversus abdominis plane block (TAP) on chronic post-groin surgeries orchalgia (chronic testicular pain)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2018
CompletedStudy Start
First participant enrolled
May 10, 2018
CompletedFirst Posted
Study publicly available on registry
May 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 25, 2019
CompletedJuly 8, 2019
July 1, 2019
1.4 years
April 29, 2018
July 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The change of intensity of pain measured by Visual Analogue Pain (VAS ) score
The Visual Analogue Pain (VAS) scale is a tool for intensity of pain scored from 0 to 10, where 0 = no pain and 10 = the worst pain imaginable
The pain assessment will be done one month, 2 month and 3 month postprocedure.
Study Arms (2)
TAP group
ACTIVE COMPARATORSHAM group
SHAM COMPARATORInterventions
Whilst the patient is in the supine position, a high frequency ultrasound probe (10 MH) is placed transverse to the abdominal wall between the costal margin and iliac crest. The needle is introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transversus abdominis muscles. Upon reaching the plane, 2 ml of saline is injected to confirm correct needle position after which 20 ml of levobupivacaine, 25% plus triamcinolone, 80 mg solution is injected for TAP group and 20 ml of saline only is injected for SHAM group.. The transversus abdominis plane is visualized expanding with the injection ( appears as a hypoechoic space)
Eligibility Criteria
You may qualify if:
- pain intensity ≥ 5 on the visual analog scale (VAS),
- pain that lasted for more than 3 months after groin surgeries,
- failed conservative treatment with nonsteroidal anti-inflammatory drugs (NSAIDs)
You may not qualify if:
- patients with other causes of scrotal pain, e.g., epididymitis, orchitis, and hydrocele,
- patients complaining of groin infection and coagulopathy,
- patients suffering from hypertension, ischemic heart disease, or psychiatric disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diab
Asyut, Assuit, 71515, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assuit university, south egypt cancer institute, anesthesia department
Study Record Dates
First Submitted
April 29, 2018
First Posted
May 16, 2018
Study Start
May 10, 2018
Primary Completion
October 15, 2019
Study Completion
November 25, 2019
Last Updated
July 8, 2019
Record last verified: 2019-07