To assess the effect of the setting of two types of anaesthesia (spinal versus general anaesthesia) on outcomes of remedial surgery (i.e. quality of life, patient satisfaction and pain relief) in patients diagnosed with chronic inguinodynia.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
pijn
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the reduction of postoperative pain, patient satisfaction
and quality of life, on short (<3 months) and long term (up to 1 year).
Secondary outcome
Secondary outcome measures are differences between the setting of anaesthesia
regarding the origin of groin pain, types of remedial surgery, preoperative use
of analgesics, direct and indirect costs of the intervention and complication
rates.
Background summary
Patients suffering from persisting inguinodynia (following inguinal hernia
repair, Pfannentiel incision or by other causes) may undergo remedial surgery
after conservative treatments failed. Remedial surgery may consist of removal
of inguinal nerves and/or mesh removal. SolviMáx is highly experienced with
these surgical treatments. Two previously performed retrospective studies have
demonstrated that the type of anaesthesia (spinal or general anaesthesia) is
associated with the outcome of remedial surgery. However, this potential
association has never been investigated in a prospective, randomized setting.
Study objective
To assess the effect of the setting of two types of anaesthesia (spinal versus
general anaesthesia) on outcomes of remedial surgery (i.e. quality of life,
patient satisfaction and pain relief) in patients diagnosed with chronic
inguinodynia.
Study design
Randomized controlled trial.
Intervention
Patients are randomized between spinal and general anaesthesia. The
conventional protocols are used for the types of anaesthesia.
Study burden and risks
All procedures will be executed following the conventional protocols, with
execption of the randomization of the type of anaesthesia (general or spinal
anaesthesia). Therefore, no additional risks are associated with participation
in the present study. Burden for patients include completing six questionnaires
regarding quality of life, pain scores, satisfaction, use of analgesics,
medical consumption, work productivity and complications (preoperative and 1
week, 6 weeks, 3 months, 6 months and 12 months postoperative).
De Run 4600
Veldhoven 5500 MB
NL
De Run 4600
Veldhoven 5500 MB
NL
Listed location countries
Age
Inclusion criteria
- Patients aged >18 years suspected for a groin pain syndrome (based on patient history, physical examination and diagnostic injection (10cc lidocaine 1-2% with or without corticosteroids);
- Persisting groin pain >=3 months;
- Unacceptable pain levels (subjective by patient) despite one or several injections with local anaesthetics or other conservative treatments;
- Groin pain with origin in one of the three inguinal nerves or inserted mesh;
- Neurectomy and/or meshectomy by an open approach;
- Informed consent obtained.
Exclusion criteria
- Groin pain caused by intercostal neuralgia (lower abdominal cutaneous nerve entrapment syndrome (ACNES));
- Involvement of the lateral femoral cutaneous nerve;
- Pregnancy;
- Contra-indications for general or spinal anesthesia;
- Indication for retroperitoneal neurectomy;
- Cognitive impairment;
- Malignancy;
- Previous remedial surgery on same site in MMC;
- Bilateral groin pain sugery;
- ASA class >III;
- Pre-existant neurological deficiency;
- Inability to speak or understand the Dutch language.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL54115.015.15 |
| Other | volgt |
| OMON | NL-OMON25028 |