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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03525938
Other study ID # SECI-IRB-IORG0006563-533
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 10, 2018
Est. completion date November 25, 2019

Study information

Verified date July 2019
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date November 25, 2019
Est. primary completion date October 15, 2019
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- The inclusion criteria were patients with chronic scrotal pain (orchialgia) that fulfilled the following criteria:

1. pain intensity = 5 on the visual analog scale (VAS),

2. pain that lasted for more than 3 months after groin surgeries,

3. failed conservative treatment with nonsteroidal anti-inflammatory drugs (NSAIDs)

Exclusion Criteria:

- The exclusion criteria were:

1. patients with other causes of scrotal pain, e.g., epididymitis, orchitis, and hydrocele,

2. patients complaining of groin infection and coagulopathy,

3. patients suffering from hypertension, ischemic heart disease, or psychiatric disorders

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
TAP block
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)

Locations

Country Name City State
Egypt Diab Assiut Assuit

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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