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ID
Source
Brief title
Health condition
Anterior Cutaneous Nerve Entrapment Syndrome (ACNES).
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint was the proportion of patients achieving at least 50 % reduction in pain perception measured on a Numeric Rating Scale (NRS) 15 minutes after the injection compared to directly before.
Secondary outcome
The secondary endpoints were the effect of the injection regimen on the long term (after 3 months) and the role of the location of the fluid depot (beneath muscle fascia or not).
Background summary
Abdominal pain has many causes. It often concerns intra-abdominal organs for which many diagnostic tests are available. However, the abdominal wall is often misunderstood as a cause of pain. Since the beginning of the last century, various authors have published about entrapment of the ramus cutaneus anterior of the intercostal nerve (Th 8-12) in the rectus abdominis muscle. Although various designations have recently appeared, mainly written about the Anterior (or Abdominal) Cutaneous Nerve Entrapment Syndrome (ACNES). A remarkable finding in this syndrome is that there is one clearly localized pain point, where the pain worsens when contracting of the abdominal muscles, the so-called sign of Carnett. This pain point is located exactly at the site of the passage of this nerve through the fascia of the rectus abdominis muscle.
If a diagnosis of ACNES is considered, it is recommended in the literature to confirm this by a diagnostic blockade using a local anesthetic around the nerve in question. f the patient indicates to be pain-free diagnosis can be considered proven.
Partly through our own research, which mainly consists of the publication of the retrospective data and two conducted double-blind randomized studies, it has now been conclusively demonstrated that this pain syndrome actually exists. One in three patients with ACNES can get pain reduction pain through an injection strategy, and it has been unambiguously demonstrated that it is the local anesthetic that works and not the volume bolus itself. Two out of three patients become permanently pain-free after a surgical neurectomy. However, many questions remain. One of those questions concerns the role of the use of ultrasound in the placement of the injection in the rectus fascia. No comparable data can be found in the literature. That is why we want to test this in a randomized study design.
Study objective
There is no difference in pain perception after 15-20 minutes between patients who received a local injection with the use of ultrasound versus a free hand technique.
Study design
Follow-up at 2, 4 and 6 weeks and after 3 months.
Intervention
Control: free hand lidocaine injection therapy
Intervention: ultrasound guided lidocain injection therapie
Inclusion criteria
All adult patients (> 18 years) were eligible when suspected for an abdominal wall pain syndrome if all of the following criteria were met:
• Single tender point (trigger point);
• Constant site of abdominal tenderness with a small ( < 2 cm) area of maximal intensity situated within the lateral boundaries of the rectus abdominis muscle;
• Tenderness increases by abdominal muscle tensing, using the Carnett’s test;
Exclusion criteria
Recent intra-abdominal pathology, lidocaine allergy, earlier treatment for ACNES, pregnancy and if adequate follow-up can’t be obtained. Informed consent was obtained if patient characteristics fulfilled these criteria.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8465 |
| Other | METC Maxima Medisch Centrum : N16.171 |