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

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.

Study Overview

• Status: Terminated
• Conditions: Hernia, Inguinal; Chronic Postoperative Pain
• Intervention / Treatment: Procedure: Ilioinguinal nerve block

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.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

• Study Contact: Name: David M Krpata, MD; Phone Number: 2164459989; Email: krpatad@ccf.org
• Study Contact Backup: Name: Michael Rosen, MD; Phone Number: 2164459989; Email: rosenm@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Not a surgical candidate

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ilioinguinal Nerve Block	Procedure: Ilioinguinal nerve block; Local anesthetic injection of the ilioinguinal nerve. This is performed in the outpatient clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 3 months after surgery
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.	Baseline and 3 months after surgery

Collaborators and Investigators

• Sponsor: The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Actual): March 25, 2024
• Study Completion (Actual): March 25, 2024

Study Registration Dates

• First Submitted: May 18, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Pain, Postoperative; Hernia, Inguinal
• Other Study ID Numbers: 21-1176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No