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

NCT05386693 | Terminated

• 1 other identifier: 21-1176
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hernia, Inguinal; Chronic Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Ilioinguinal Nerve Block

Procedure: Ilioinguinal nerve block

Interventions

Ilioinguinal nerve block PROCEDURE

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

Ilioinguinal Nerve Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Not a surgical candidate

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 23, 2022
• Study Start: April 20, 2022
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)