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Study Comparing Botulinum Toxin Type A, Triamcinolone Acetonide, and Bupivacaine for Treating Persistent Post-Surgical Scar Pain in Adults

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on managing post-surgical scar pain, which is pain that persists for more than three months after surgery. The study is comparing two treatments: Botulinum Toxin Type A, commonly known as Botox, and a type of corticosteroid called Triamcinolone Acetonide. Botox is a protein that can help relax muscles, while Triamcinolone Acetonide is a medication that reduces inflammation and is often used to treat various skin conditions.

The purpose of the study is to determine if Botox is more effective than corticosteroids in treating persistent pain from surgical scars. Participants in the study will receive injections of either Botox or the corticosteroid. The study will monitor the participants' pain levels and any changes they experience over a set period. The injections are given intradermally, which means they are administered just under the skin.

Throughout the study, participants' pain will be assessed using a numerical rating scale, and additional questionnaires will be used to evaluate their overall pain experience and any changes in their condition. The study will also document any side effects that may occur. This research aims to provide better treatment options for individuals suffering from long-lasting pain after surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying that you are over 18 years of age and have persistent post-surgical pain lasting more than 3 months.
You will be asked to provide written informed consent, indicating your understanding and agreement to participate in the trial.
Step 2
Baseline measurements
Before starting the treatment, baseline measurements of your pain levels will be taken. This involves using a numerical rating scale of pain (NRS) to assess your current pain intensity.
Additional assessments may include the brief pain inventory score (short form) (BPI-sf) and the pain self-efficacy questionnaire (PSEQ) to evaluate how pain affects your daily activities and your confidence in managing it.
Step 3
Treatment administration
You will receive one of the following treatments: Bupivacaine 2.5mg/ml Solution for Injection, BOTOX 100 Allergan Units Powder for Solution for Injection, or Adcortyl™ Intra-articular / Intradermal Injection 10 mg/ml, Suspension for Injection.
The treatment will be administered through intradermal use, which means it will be injected into the skin at the site of your post-surgical scar.
Step 4
Follow-up visits
You will have scheduled follow-up visits to monitor your progress and any changes in your pain levels. These visits will include repeating the pain assessments using the NRS, BPI-sf, and PSEQ.
During these visits, any adverse events or side effects will be documented, and you will be asked to provide your global impression of change (PGIC) regarding your pain management.
Step 5
End of trial assessment
At the end of the trial, a final assessment will be conducted to evaluate the overall effectiveness of the treatment you received.
This will include a comprehensive review of your pain levels, any side effects experienced, and your personal feedback on the treatment's impact on your post-surgical scar pain.

Who can join the trial?

4 criteria

Both male and female patients can participate.
Participants must be over 18 years of age.
Participants must have a diagnosis of persistent post-surgical pain, which means pain that lasts more than 3 months after surgery.
Participants must be able to provide written informed consent, which means they understand the study and agree to take part in it.

Who cannot join the trial?

3 criteria

Patients who are not experiencing post-surgical scar pain cannot participate.
Patients who are younger than 18 years old or older than 65 years old cannot participate.
Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.

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Investigated drugs

Botulinum Toxin
is a medication that is often used to reduce muscle stiffness and spasms. In this trial, it is being tested to see if it can help reduce pain in scars that remain after surgery. The idea is that it might help by relaxing the muscles around the scar, which could decrease the pain.
Corticosteroids
are a type of medication that can reduce inflammation and swelling. They are commonly used to treat a variety of conditions that involve inflammation. In this trial, corticosteroids are being used to see if they can help reduce pain in post-surgical scars by decreasing the inflammation in the area of the scar.

What is already known about the treatment

Botulinum toxin
Botulinum toxin is administered through an injection directly into the affected area, typically by a healthcare professional. It is currently being studied for its effectiveness in treating persistent pain from scars after surgery. The main use of botulinum toxin in this context is to reduce pain associated with surgical scars. It works by blocking nerve signals that cause muscles to contract, which can help alleviate pain. Botulinum toxin is classified as a neurotoxin and is commonly known for its ability to relax muscles.
Corticosteroids
Corticosteroids are usually administered through an injection into the area around the scar by a healthcare provider. They are well-established in medical practice for reducing inflammation and pain, including pain from surgical scars. The primary use of corticosteroids in this trial is to manage pain from post-surgical scars. They work by suppressing the immune response and reducing inflammation, which can help decrease pain. Corticosteroids are classified as anti-inflammatory medications.

Investigated diseases

Post-surgical scar pain – This condition occurs when pain persists in the area of a surgical scar after the wound has healed. It is often due to nerve damage or irritation during the surgical procedure. The pain can be sharp, burning, or throbbing and may vary in intensity. It can be triggered by touch, movement, or changes in temperature. Over time, the pain may decrease as the nerves heal, but in some cases, it can become chronic. The condition can affect daily activities and quality of life, requiring management to alleviate discomfort.