Transversus Abdominis Plane Block for Chronic Postsurgical Orchalgia

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

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

Study Overview

• Status: Unknown
• Conditions: Chronic Post-surgical Pain
• Intervention / Treatment: Procedure: TAP block

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assuit
    • Assiut, Assuit, Egypt, 71515
      • Recruiting
      • Diab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TAP group	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)
Sham Comparator: SHAM group	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)

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.

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2018
• Primary Completion (Anticipated): October 15, 2019
• Study Completion (Anticipated): November 25, 2019

Study Registration Dates

• First Submitted: April 29, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 16, 2018

Study Record Updates

• Last Update Posted (Actual): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 3, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: SECI-IRB-IORG0006563-533

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No