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TerminatedNCT05386693Updated Apr 5, 2024

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

An observational study in Hernia, Inguinal and Chronic Postoperative Pain, sponsored by The Cleveland Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-05.

Sponsored by The Cleveland Clinic · Observational

Why this study was terminated
Low enrollment
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Hernia, Inguinal
  • Chronic Postoperative Pain
03

In context

Hernia, Inguinal

561 studies on the registry are indexed under Hernia, Inguinal; 76 are open to participants now.

This study's enrollment of 10 is below the median of 150 across 137 observational studies indexed under Hernia, Inguinal.

Browse Hernia, Inguinal studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Not a surgical candidate
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (actual)
Patient registry
No

Groups and cohorts

  • Ilioinguinal Nerve Block

    Procedure: Ilioinguinal nerve block

Interventions

  • ProcedureIlioinguinal nerve block

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: Baseline and 3 months after surgery

07

Study locations

1 site
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2022 to primary completion in Mar 2024, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 18, 2022
First posted
May 23, 2022
StartActual
Apr 20, 2022
Primary completionActual
Mar 25, 2024
CompletionActual
Mar 25, 2024
Last update
Apr 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05386693
Responsible party
David Krpata (Principal Investigator, The Cleveland Clinic) — Principal investigator
First posted
May 23, 2022
Start date
Apr 20, 2022
Primary completion
Mar 25, 2024
Completion
Mar 25, 2024
Last update
Apr 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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