Chronic Post-surgical PainNCT03525938
Transversus Abdominis Plane Block for Chronic Postsurgical Orchalgia
A study testing TAP block in people with Chronic Post-surgical Pain, run by Assiut University at 1 site in Egypt.
Trial summary
the study will evaluate the effect of transversus abdominis plane block (TAP) on chronic post-groin surgeries orchalgia (chronic testicular pain) Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Chronic Post-surgical Pain
- What is being tested?
- TAP block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2018to 25 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Diab
Asyut, Assuit, 71515
Diab Hetta, MD, +201091090009, diabgetta25@gmail.com
About this study
Official title: 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)
- Conditions
- Chronic Post-surgical Pain
- Being tested
- TAP block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP blockProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| TAP group | Active comparator | Not described Receives: Procedure: TAP block |
| SHAM group | Sham comparator | Not described Receives: Procedure: TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The pain assessment will be done one month, 2 month and 3 month postprocedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start10 May 2018
- Primary completion15 Oct 2019 (estimated)
- Study completion25 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Post-surgical PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diab Fuad Hetta, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525938
- Sponsor's protocol ID
- SECI-IRB-IORG0006563-533
- Status last verified
- Jul 2019
- First submitted
- 29 Apr 2018
- Last updated
- 8 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane Block for Chronic Postsurgical Orchalgia: SHAM Controlled, Randomized Trial, Three Months Results
- ClinicalTrials.gov ID
- NCT03525938
- Acronym / sponsor ID
- SECI-IRB-IORG0006563-533
- Conditions
- Chronic Post-surgical Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 May 2018 (actual)
- Primary completion
- 15 Oct 2019 (estimated)
- Study completion
- 25 Nov 2019 (estimated)
- First posted
- 16 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
the study will evaluate the effect of transversus abdominis plane block (TAP) on chronic post-groin surgeries orchalgia (chronic testicular pain)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP group | Active comparator | Procedure: TAP block |
| SHAM group | Sham comparator | Procedure: TAP block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The inclusion criteria were patients with chronic scrotal pain (orchialgia) that fulfilled the following criteria:
Key exclusion criteria (4 listed)
- The exclusion criteria were:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAP blockWhilst 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) | Procedure or surgery | SHAM group, TAP group |
Primary outcome
The change of intensity of pain measured by Visual Analogue Pain (VAS ) score
Time frame: The pain assessment will be done one month, 2 month and 3 month postprocedure.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP block in people with Chronic Post-surgical Pain, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of intensity of pain measured by Visual Analogue Pain (VAS ) score (time frame: The pain assessment will be done one month, 2 month and 3 month postprocedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.