Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05386693 |
| Other study ID # |
21-1176 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 20, 2022 |
| Est. completion date |
March 25, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
The Cleveland Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The management of chronic pain after inguinal hernia surgery presents unique challenges.
Ilioinguinal nerve blocks are often used in the initial treatment of this disease. This can
often be followed by surgery, including neurectomy and/or hernia mesh removal. In an effort
to identify preoperative predictors of postoperative outcomes following these surgical
interventions the investigators devised a study to prospectively evaluate and correlate a
patients pre-operative response to an ilioinguinal nerve block with their post-operative
outcomes following surgery for chronic groin pain after inguinal hernia surgery.
Description:
In the United States, 800,000 inguinal hernia repairs are performed annually, making it one
of the most common surgical procedures.1,2 While major advancement has been gained in
minimizing hernia recurrence, chronic pain after groin hernia repair remains the most common
and significant complication of this surgery, drastically affecting patients' quality of
life.3,4 Chronic pain has a substantial impact on physical, emotional, and cognitive
function, on social and family life, and on the ability to work and secure an income 5. It
has been reported that 5-10% of patients undergoing inguinal hernia repair develop
postoperative chronic pain, the etiology of which remains unclear.6,7 Multiple behavioral,
physical, and pharmacological interventions have shown positive results in treating chronic
postoperative inguinal pain.8 Yet, some patients develop refractory pain severe enough to
warrant removing the nerve tissue carrying the pain signal from the inguinal region, a
procedure called neurectomy. While neurectomy provides an excellent outcome for some
patients, others have no clear benefit from this surgery. 1,8-10 The challenge remains to
identify which patients will gain the most advantage from neurectomy. Identifying patients
who are least likely to benefit from the neurectomy will help spare them going through
unnecessary pain and risk from the surgical intervention, reduce the cost of medical care,
and focus efforts on other interventions that may provide better outcomes. This study aims to
answer the question of whether or not pre-operative injection of an inguinal nerve predicts a
patient's response to neurectomy.
Specific Aims
During the preoperative assessment for neurectomy, patients undergo a minor procedure
involving injecting a local analgesic around the nerve, a nerve block. In this study, the
investigators propose providing the patients with pain and quality of life questionnaires and
tools to assess their baseline pain, response to the local analgesics, and response to the
neurectomy procedure. The specific aims of the study are:
1. Evaluate the reliability of nerve block to predict patient response to neurectomy
procedure:
While nerve blocks have been frequently used as part of the preoperative assessment to
neurectomy, the response from nerve block has not been correlated with post-neurectomy
pain outcomes. The investigators intend to objectively assess pain relief in response to
nerve block and neurectomy in this specific aim.
The investigators hypothesized that patients who reported relief in response to nerve
blocks would have pain relief from post neurectomy procedure, and patients who did not
experience relief from nerve blocks will not have relief from post neurectomy procedure.
2. Evaluate the correlation between the extent of pain relief from nerve block to post
neurectomy pain relief:
The Visual Assessment Scale (VAS) is a tool that provides a quantified assessment of pain.
Assessing the pain with VAS before and after nerve block will provide a scale of change in
pain level in response to the nerve block injection, the extent of which can be correlated
with post neurectomy VAS to predict the outcome. The investigators hypothesize that patients
with a greater improvement in pain level in response to nerve block have a higher chance of
achieving pain relief with neurectomy than those with a low improvement in pain level from
the nerve block.
