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Hernia, InguinalNCT05386693

Surgical Outcomes Following Neurectomy Based Upon Response to Local Anesthetic Injection in Chronic Groin Pain

An observational study of Hernia, Inguinal and Chronic Postoperative Pain, run by The Cleveland Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hernia, Inguinal, Chronic Postoperative Pain
What is being tested?
Ilioinguinal nerve block
How many people
10 participants
Where
1 siteUnited States
Study dates
20 Apr 2022to 25 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients undergoing surgical intervention of chronic post-operative inguinal pain after inguinal hernia repair with or without mesh.

Who may be able to join

  • Adult patients (18 years of older)
  • Chronic groin pain

Who cannot join

  • Not a surgical candidate

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cleveland Clinic

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Predicting Surgical Outcomes Following Neurectomy Based Upon Response to Local Anesthetic Injection in Chronic Groin Pain Patients

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.

Read the detailed 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.

Being tested
Ilioinguinal nerve block
Medical subject headings
Hernia, Inguinal, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ilioinguinal nerve blockProcedure or surgery

    Local anesthetic injection of the ilioinguinal nerve. This is performed in the outpatient clinic.

Study groups in NCT05386693
Study groupRoleWhat they receive
Ilioinguinal Nerve BlockNot described
Receives: Procedure: Ilioinguinal nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in pain levels

    Pain as measured with the Visual Analogue Scale (VAS) using a scale of 0 to 100; with 0 being the least amount of pain and 100 being the most amount of pain.

    Measured: Baseline and 3 months after surgery

  2. Change in pain levels

    Pain as measured with the Chronic Groin Pain Questionnaire which uses a Numeric Rating Scale (NRS). NRS uses a scale of 0 to 10; with 0 being the least amount of pain and 10 being the most amount of pain.

    Measured: Baseline and 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2022
  2. Study start20 Apr 2022
  3. Primary completion25 Mar 2024
  4. Study completion25 Mar 2024

Why it stopped: Low enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05386693
Sponsor's protocol ID
21-1176
Status last verified
Apr 2024
First submitted
18 May 2022
Last updated
5 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hernia, Inguinal and Chronic Postoperative Pain, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Low enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain levels (time frame: Baseline and 3 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.

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