Transversus Abdominis Plane Block for Chronic Postsurgical Orchalgia

NCT ID: NCT03525938

Last Updated: 2019-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-10
• Study Completion Date: 2019-11-25

Brief Summary

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

Conditions

Chronic Post-surgical Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TAP group

Group Type: ACTIVE_COMPARATOR

TAP block

Intervention Type: PROCEDURE

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)

SHAM group

Group Type: SHAM_COMPARATOR

TAP block

Intervention Type: PROCEDURE

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)

Interventions

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)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Diab Fuad Hetta

Assuit university, south egypt cancer institute, anesthesia department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Diab

Asyut, Assuit, Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Diab Hetta, MD

Role: primary

diabgetta25@gmail.com

+201091090009

Other Identifiers

SECI-IRB-IORG0006563-533

Identifier Type: -

Identifier Source: org_study_id