Transversus Abdominis Plane Block for Chronic Postsurgical Orchalgia

Study Overview
=================
Brief Summary
-----------------
the study will evaluate the effect of transversus abdominis plane block (TAP) on chronic post-groin surgeries orchalgia (chronic testicular pain)

Official Title
-----------------
Transversus Abdominis Plane Block for Chronic Postsurgical Orchalgia: SHAM Controlled, Randomized Trial, Three Months Results

Conditions
-----------------
Chronic Post-surgical Pain

Intervention / Treatment
-----------------
* Procedure: TAP block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria were patients with chronic scrotal pain (orchialgia) that fulfilled the following criteria: 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) Exclusion Criteria: The exclusion criteria were: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TAP group<br> | Procedure: TAP block<br>* 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)<br>|
| Sham Comparator: SHAM group<br> | Procedure: TAP block<br>* 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)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |