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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
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:
- 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.
- 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.
- Conditions
- Hernia, Inguinal, Chronic Postoperative Pain
- 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 group | Role | What they receive |
|---|---|---|
| Ilioinguinal Nerve Block | Not described Receives: Procedure: Ilioinguinal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
- First posted23 May 2022
- Study start20 Apr 2022
- Primary completion25 Mar 2024
- Study completion25 Mar 2024
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Krpata, The Cleveland Clinic
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Surgical Outcomes Following Neurectomy Based Upon Response to Local Anesthetic Injection in Chronic Groin Pain Patients
- ClinicalTrials.gov ID
- NCT05386693
- Acronym / sponsor ID
- 21-1176
- Conditions
- Hernia, Inguinal, Chronic Postoperative Pain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 25 Mar 2024 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ilioinguinal Nerve Block | – | Procedure: Ilioinguinal nerve block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgical intervention of chronic post-operative inguinal pain after inguinal hernia repair with or without mesh.
Key inclusion criteria (2 listed)
- Adult patients (18 years of older)
- Chronic groin pain
Key exclusion criteria (1 listed)
- Not a surgical candidate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ilioinguinal nerve blockLocal anesthetic injection of the ilioinguinal nerve. This is performed in the outpatient clinic. | Procedure or surgery | Ilioinguinal Nerve Block |
Primary outcome
Change in pain levels
Time frame: Baseline and 3 months after surgery
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.
Change in pain levels
Time frame: Baseline and 3 months after surgery
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.
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.