Local vs General Anesthesia for Inguinal Hernia Repair in Older Adults

Recruiting at 2 trial locations

Overseen By Benjamin Cher

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

80 Participants Needed

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

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
• Inguinal Hernia Surgery
• Local Anesthesia

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.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

American Federation for Aging Research

Collaborator

Trials

9

Recruited

2,500+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

The John A. Hartford Foundation

Collaborator

Trials

18

Recruited

7,500+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Findings from Research

Inguinal hernia repair using local anesthesia significantly reduces postoperative complications in patients aged 75 and older, with a 0.6% decrease in complications compared to general anesthesia.

Local anesthesia also leads to faster operative times in patients under 75 years old and could save the healthcare system between $9 million to $45 million annually, making it a cost-effective option for hernia repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Local Anesthesia for Inguinal Hernia Repair Reduces Complications in Older Patients. Balentine, CJ., Meier, J., Berger, M., et al.[2022]

In a study of 97,437 patients undergoing inguinal hernia repair, local anesthesia was linked to a 37% reduction in postoperative complications compared to general anesthesia, suggesting it may be a safer option, especially for older adults.

Patients receiving local anesthesia experienced a 13% decrease in operative time and a 27% shorter recovery room stay, indicating that local anesthesia not only improves safety but also enhances efficiency in surgical recovery.

NCBI (Pubmed)

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. Balentine, CJ., Meier, J., Berger, M., et al.[2022]

In three randomized studies involving 300 adults with primary inguinal hernias, local anesthesia was found to significantly reduce postoperative complications compared to other methods.

Patients receiving local anesthesia experienced quicker discharges and reported higher satisfaction, making it an ideal choice for adult hernia repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgery of inguinal hernia with local anesthesia--technique and results of a minimal invasive procedure]. Rau, HM., Arlt, G., Peiper, C., et al.[2014]

In a study of 470 inguinal hernia repairs, local anaesthesia (LA) was found to be preferred for older patients (≥70 years), with 63% of older patients undergoing surgery under LA compared to 35% under general anaesthesia (GA).

LA resulted in significantly higher day case rates (81% for LA vs. 33% for GA), while showing no significant differences in early complications, satisfaction rates, or long-term recurrence, suggesting LA is a safer and more efficient option for older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lichtenstein hernia repair under different anaesthetic techniques with special emphasis on outcomes in older people. Sanjay, P., Leaver, H., Shaikh, I., et al.[2016]

Local anesthesia for inguinal hernia repair is effective and offers several advantages over general and regional anesthesia, including reduced postoperative pain, lower analgesic needs, and quicker recovery times.

It is particularly beneficial for elderly or fragile patients, as it allows for earlier mobilization and intake of food and liquids, making it a safer and more economical option for hernia repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current options in local anesthesia for groin hernia repairs. Kulacoglu, H., Alptekin, A.[2019]

Local infiltration anaesthesia is recommended for inguinal hernia surgery as it is associated with lower costs and less urinary morbidity compared to general and regional anaesthesia, based on data from 57,505 elective surgeries in Denmark.

Despite evidence favoring local anaesthesia, the majority of surgeries (63.6%) were still performed under general anaesthesia, indicating a need for a shift in practice to improve patient recovery and reduce healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anaesthetic practice for groin hernia repair--a nation-wide study in Denmark 1998-2003. Kehlet, H., Bay Nielsen, M.[2018]

References

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

Using Local Anesthesia for Inguinal Hernia Repair Reduces Complications in Older Patients. [2022]

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]

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

[Surgery of inguinal hernia with local anesthesia--technique and results of a minimal invasive procedure]. [2014]

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

Lichtenstein hernia repair under different anaesthetic techniques with special emphasis on outcomes in older people. [2016]

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

Current options in local anesthesia for groin hernia repairs. [2019]

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

Anaesthetic practice for groin hernia repair--a nation-wide study in Denmark 1998-2003. [2018]