Evaluation of the effect ofdiagnostic and therapeutic proces in reducing pain in patients suspected with ACNES.Is injection of lidocaine in patients suspected of ACNES leading to a larger group of people with a clinically relevant reduction of pain…
ID
Source
Brief title
Condition
- Peripheral neuropathies
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in number of patients with a clinically relevant reducion of
pain on VAS, 15 min after injection of Lidocain vs saline.
The difference in number of patients with a clinically relevant reducion of
pain on VAS after neurectomie vs sham operation.
A more than 50 % reduction on VAS is considered clinically relevant.
Secondary outcome
Fase 1, Diagnostic
* the difference in the number of people with longterm painfree result after
diagnostic injection (VAS<10)
* the absolute en relative difference on the VAS.
* difference on Verbal Rating Score (VRS)
Fase 2 en 3, therapie
* The number of patients pain free at 3 months after injection of lidocaine and
Kenacort
* Long term evaluation: frequency of patients developping a recurrent pain at
the site of surgery after a pain free period (VAS < 10) of at least 6 weeks
after neurectomy.
* Difference on the VRS
* difference in improvement on the SF-36
Background summary
Entrapment of one or more nerve branches in the rectus abdominis muscle , known
as the anterior cutaneus nerve entrapment syndrome (ACNES), can cause abdominal
pain and discomfort. It is often overseen as a cause of abdominal pain. Once
diagnosed several therapeutic options are available. Our studiegroup propagates
neurectomy, dissection of the nerve branches perforating the anterior fascia of
the rectus abdominis muscle. In our own experience this leads to succesfully
improving complaints in patients in about 75 % of the cases. Pain specialists
and non-believers remain critical and doubt the surgical intervention to be
usefull for various reasons.
Study objective
Evaluation of the effect ofdiagnostic and therapeutic proces in reducing pain
in patients suspected with ACNES.
Is injection of lidocaine in patients suspected of ACNES leading to a larger
group of people with a clinically relevant reduction of pain compaired to
saline? Is neurectomy in patients suspected of ACNES leading to a larger group
of people with a clinically relevant reduction of pain compaired to a 'sham'
operation.
a 50 % reduction on the Visual Analouge Scale (VAS) is considered clinically
relevant.
Study design
Double-blind randomised mono-centre trial devided in an diagnostic fase and a
therapeutic fase.
Intervention
Fase 1, diagnostic: Injection of lidocaine vs saline at the painpoint
Fase 2, therapeutic conservative: injection of lidocaine and Kenacort at the
painpoint in all patients
Fase 3, therapeutic operative: Neurectomy vs Sham operation.
Study burden and risks
The risk is cinsidered minor and no different than any procedure. Both
infection and hematoma are the most common complications, alltough rare (less
than 5 %), for injection and/or surgery. Sujested surgery is superficial and
minor.
The biggest burden is on those subjected to a sham or placebo procedure. They
potentially remain in pain for at least 6 weeks more. Eventually they will be
offered a neurectomy at a later state. No longterm os irriversable hazzards are
to be expected.
There is no personal benefit. This study will provide evidency of the entity
ACNES and usefull treatment. More widespread knowlege of ACNES might prevent
future patients to be submitted to unnecessary diagnostic procedures and even
major abdominal surgery
De Run 4600 Postbus 7777
5500 MB Veldhoven
Nederland
De Run 4600 Postbus 7777
5500 MB Veldhoven
Nederland
Listed location countries
Age
Inclusion criteria
Localized abdominal wall pain in the rectus muscle
positive Carnett sign
Exclusion criteria
Suspected intra-abdominal pain
Anticoagulants use
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL23189.015.08 |