Transversus Abdominis Plane Block for Chronic Postsurgical Orchalgia

Chronic Post-surgical Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03525938
• Other study ID #: SECI-IRB-IORG0006563-533
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Post-surgical Pain

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.