Local vs General Anesthesia for Inguinal Hernia Repair in Older Adults

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Courtney Balentine, MD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Wisconsin, Madison

Disqualifiers: Prior hernia repair, Anesthesia allergies, Infections, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Inguinal hernia repair-the most common general surgery operation in the U.S.-provides a unique opportunity to improve outcomes for older patients by changing surgical practice. Nearly 80% of inguinal hernia operations are performed under general anesthesia versus 15-20% using local anesthesia, despite the absence of evidence for superiority. The choice of anesthesia has particular implications for older adults because they face substantial short- and long-term risk of cognitive and physical decline after exposure to general anesthesia. Consequently, the American College of Surgeons and the American Geriatrics Society have identified a critical need in surgery: determining which operations have better outcomes when performed under local rather than general anesthesia. Currently, the evidence for choosing an anesthesia technique for inguinal hernia repair in older adults is inconclusive. Several small randomized trials and cohort studies have suggested that using local anesthesia for hernia repair reduces morbidity by one-third, unplanned readmissions by 20%, and operative time and costs by 15% while other studies showed no significant differences. However, there are significant flaws in these studies that severely limit their applicability to older adults: (1) They mainly focused on younger patients with limited comorbidity burden, largely ignoring individuals aged 65 years and older, (2) They did not adequately examine the effects of general anesthesia on cognitive function and quality of life for older adults and their caregivers, (3) They did not consult with stakeholders to identify outcomes relevant to those groups. The current study aims to address these limitations to determine the ideal anesthesia modality for inguinal hernia repair.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for inguinal hernia repair in older adults?

Research shows that using local anesthesia for inguinal hernia repair in older adults can lead to fewer complications, shorter surgery times, and faster recovery compared to general anesthesia. Local anesthesia is also more cost-effective and better tolerated by older patients, making it a suitable option for this group. ^{1 2 3 4 5}

Is local anesthesia safe for inguinal hernia repair in older adults?

Local anesthesia for inguinal hernia repair is generally safe and has advantages over general anesthesia, especially for older adults. It leads to fewer complications, less pain, and quicker recovery, making it a suitable option for elderly patients. ^{1 2 3 5 6}

How does local anesthesia for inguinal hernia repair differ from general anesthesia?

Local anesthesia for inguinal hernia repair is unique because it reduces complications, shortens operative time, and enhances recovery, especially in older adults. It allows patients to avoid the side effects of general anesthesia, such as nausea and urinary retention, and enables quicker mobilization and discharge from the hospital. ^{1 2 3 4 5}

Research Team

Courtney Balentine, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for people aged 65 or older with a unilateral inguinal hernia that hasn't been repaired before and isn't trapped. They must be fit for either general or local anesthesia, willing to follow the study plan for six months post-surgery, and speak English as their primary language.

Inclusion Criteria

I am 65 years old or older.

I have a one-sided groin hernia that isn't trapped.

I am willing to follow the study's requirements for six months after surgery.

Exclusion Criteria

I have a trapped or pinched hernia.

I need another surgery at the same time as my hernia repair.

Enrollment in other research studies

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo inguinal hernia repair surgery under either local or general anesthesia

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, effectiveness, and satisfaction after surgery

6 months

Multiple visits (in-person and virtual)

Outcome Assessment

Assessment of participant satisfaction, cognitive function, and quality of life

6 months

Treatment Details

Interventions

• General Anesthesia (Procedure)
• Inguinal Hernia Surgery (Procedure)
• Local Anesthesia (Procedure)

Trial Overview The study compares outcomes of inguinal hernia surgery using different types of anesthesia: open repair under local anesthesia versus open repair or laparoscopic/robotic repair under general anesthesia in older adults.

Participant Groups

Group I: Open Inguinal Repair- Local anesthesia Experimental Treatment 1 Intervention

This arm will receive local anesthesia for their open inguinal hernia repair.

Group II: Inguinal Hernia Repair- General Anesthesia Active Control 1 Intervention

This arm will receive general anesthesia for their open inguinal hernia repair.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Texas Southwestern Medical Center Dallas, TX

Baylor College of Medicine Houston, TX

University of Wisconsin Madison, WI

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1249

Patients Recruited

3,255,000+

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1102

Patients Recruited

1,077,000+

American Federation for Aging Research

Collaborator

Trials

9

Patients Recruited

2,500+

National Institute on Aging (NIA)

Collaborator

Trials

1841

Patients Recruited

28,150,000+

The John A. Hartford Foundation

Collaborator

Trials

18

Patients Recruited

7,500+

Baylor College of Medicine

Collaborator

Trials

1044

Patients Recruited

6,031,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Using Local Anesthesia for Inguinal Hernia Repair Reduces Complications in Older Patients. [2022] Inguinal hernia repair is the most common general surgery operation in the United States. Nearly 80% of inguinal hernia operations are performed under general anesthesia versus 15%-20% using local anesthesia, despite the absence of evidence for the superiority of the former. Although patients aged 65 y and older are expected to benefit from avoiding general anesthesia, this presumed benefit has not been adequately studied. We hypothesized that the benefits of local over general anesthesia for inguinal hernia repair would increase with age.

2. United States pubmed.ncbi.nlm.nih.gov

Using local rather than general anesthesia for inguinal hernia repair is associated with shorter operative time and enhanced postoperative recovery. [2022] Inguinal hernia repair is the most common general surgery procedure and can be performed under local or general anesthesia. We hypothesized that using local rather than general anesthesia would improve outcomes, especially for older adults.

3. Germany pubmed.ncbi.nlm.nih.gov

[Surgery of inguinal hernia with local anesthesia--technique and results of a minimal invasive procedure]. [2014] In three prospective, randomized studies we analyzed the advantages of local anesthesia in patients with primary inguinal hernias. Each study consisted of 100 cooperative adults, using an open approach and the transinguinal procedure. Due to reduced postoperative complications, increased effectiveness of hospital resources, earlier discharges and a high acceptance by the patients, local anesthesia is the ideal treatment in adult hernia repair.

4. Australia pubmed.ncbi.nlm.nih.gov

Lichtenstein hernia repair under different anaesthetic techniques with special emphasis on outcomes in older people. [2016] This study compared local (LA) and general anaesthesia (GA) for elective inguinal hernia repair with specific reference to older people (≥70 years).

5. Serbia pubmed.ncbi.nlm.nih.gov

Current options in local anesthesia for groin hernia repairs. [2019] Inguinal hernia repair is one of the most common procedures in general surgery. All anesthetic methods can be used in inguinal hernia repairs. Local anesthesia for groin hernia repair had been introduced at the very beginning of the last century, and gained popularity following the success reports from the Shouldice Hospital, and the Lichtenstein Hernia Institute. Today, local anesthesia is routinely used in specialized hernia clinics, whereas its use is still not a common practice in general hospitals, in spite of its proven advantages and recommendations by current hernia repair guidelines. In this review, the technical options for local anaesthesia in groin hernia repairs, commonly used local anaesthetics and their doses, potential complications related to the technique are evaluated. A comparison of local, general and regional anesthesia methods is also presented. Local anaesthesia technique has a short learning curve requiring simple training. It is easy to learn and apply, and its use is in open anterior repairs a nice way for health care economics. Local anesthesia has been shown to have certain advantages over general and regional anesthesia in inguinal hernia repairs. It is more economic and requires a shorter time in the operating room and shorter stay in the institution. It causes less postoperative pain, requires less analgesic consumption; avoids nausea, vomiting, and urinary retention. Patients can mobilize and take oral liquids and solid foods much earlier. Most importantly, local anesthesia is the most suitable type of anesthesia in elder, fragile patients and patients with ASA II-IV scores.

6. England pubmed.ncbi.nlm.nih.gov

Anaesthetic practice for groin hernia repair--a nation-wide study in Denmark 1998-2003. [2018] Recent scientific data suggest that local infiltration anaesthesia for inguinal hernia surgery may be preferable compared to general anaesthesia and regional anaesthesia, since it is cheaper and with less urinary morbidity. Regional anaesthesia may have specific side-effects and is without documented advantages on morbidity in this small operation.