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Transversus Abdominis Plane Block for Chronic Postsurgical Orchalgia

Primary Purpose

Chronic Post-surgical Pain

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

TAP block

About this trial

This is an interventional treatment trial for Chronic Post-surgical Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

DiabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

TAP group

SHAM group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03525938

First Posted

April 29, 2018

Last Updated

July 3, 2019

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03525938

Brief Title

Transversus Abdominis Plane Block for Chronic Postsurgical Orchalgia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Unknown status

Study Start Date

May 10, 2018 (Actual)

Primary Completion Date

October 15, 2019 (Anticipated)

Study Completion Date

November 25, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Post-surgical Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TAP group

Arm Type

Active Comparator

Arm Title

SHAM group

Arm Type

Sham Comparator

Intervention Type

Procedure

Intervention Name(s)

TAP block

Intervention Description

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)

Primary Outcome Measure Information:

Title

The change of intensity of pain measured by Visual Analogue Pain (VAS ) score

Description

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

Time Frame

The pain assessment will be done one month, 2 month and 3 month postprocedure.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Diab

City

Assiut

State/Province

Assuit

ZIP/Postal Code

71515

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Diab Hetta, MD

Phone

+201091090009

diabgetta25@gmail.com

12. IPD Sharing Statement

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Transversus Abdominis Plane Block for Chronic Postsurgical Orchalgia

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