Local vs General Anesthesia for Inguinal Hernia Repair in Older Adults

Recruiting at 2 trial locations

Overseen By Benjamin Cher, MD, MS

Age: 18+

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether local or general anesthesia is more beneficial for older adults undergoing inguinal hernia surgery. The researchers compare these anesthesia types to identify which leads to better recovery and fewer complications, as older adults may experience cognitive and physical declines after general anesthesia. Participants will receive either local or general anesthesia during their surgery. Suitable candidates for this trial are adults aged 65 and older with a single-sided inguinal hernia that has not been previously repaired and who are open to either type of anesthesia. As an unphased trial, this study allows participants to contribute to valuable research that could enhance surgical outcomes for older adults.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that local anesthesia for hernia repair is safe for patients. One study found it reduced complications by 29% and decreased unexpected hospital visits by 19%. Patients also required fewer painkillers after surgery. Another study found that those who received local anesthesia experienced less pain and could move more easily post-surgery. Overall, these findings suggest that local anesthesia is well-tolerated and may aid in a smoother recovery.

For any concerns, consult your doctor to determine the best option for you. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring different anesthesia options for inguinal hernia repair in older adults because these methods could significantly impact recovery and safety. Unlike the standard use of general anesthesia, which can sometimes pose risks for older patients, local anesthesia offers a potentially safer alternative with fewer side effects and a quicker recovery time. This trial aims to find out if local anesthesia could become a preferred option, offering a more tailored approach to surgery that prioritizes patient comfort and outcomes.

What evidence suggests that this trial's anesthesia techniques could be effective for inguinal hernia repair in older adults?

This trial will compare local anesthesia with general anesthesia for inguinal hernia repair in older adults. Research has shown that local anesthesia for this procedure can yield better results than general anesthesia. Specifically, studies have found that local anesthesia reduces post-surgery complications by 37%. It also typically shortens the surgery by about 13% and speeds up patient recovery. Patients often experience fewer issues and report higher satisfaction with local anesthesia. These findings suggest that local anesthesia might be a safer and more effective option for older adults undergoing hernia repair surgery. ^{3 6 7 8 9}

Who Is on the Research Team?

Courtney Balentine, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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: Observational: Standard of Care Active Control 1 Intervention

Participants will receive anesthesia and surgery as decided by their care team.

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

This arm will receive general anesthesia for their open inguinal hernia repair or laparoscopic / robotic 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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7953586/

Using local rather than general anesthesia for inguinal ... Local anesthesia was associated with a 37% decrease in the odds of postoperative complications (95% CI 0.54–0.73), a 13% decrease in operative time (95% CI 17.5 ...

2. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2799987

Comparison of Postoperative Outcomes of Laparoscopic vs ... In this study, laparoscopic and open repair with local anesthesia were reasonable options for patients with initial unilateral inguinal hernias.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1015958421006400

Novel local anesthesia technique 'NATURE ' (Nerves And ... The use of local anaesthesia infiltration techniques may attenuate pain following endo-laparoscopic inguinal hernia surgery. We aim to reduce post-operative ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9076752/

Use of Local Anesthesia for Inguinal Hernia Repair Has ... The use of local anesthesia decreased steadily, from 38.2% at the beginning year to 15.1% in the final year.

5. healthcare-bulletin.co.uk healthcare-bulletin.co.uk/article/comparison-of-spinal-anesthesia-versus-local-anesthesia-for-inguinal-hernia-repair-3029/

Comparison of Spinal Anesthesia versus Local ... Local anesthesia provides faster recovery, fewer complications, and higher patient satisfaction compared to spinal anesthesia for inguinal hernia repair.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2048598/

Inguinal Hernia Repair: Local or General Anaesthesia? This study demonstrates that the use of LA results in increased day-case rates, lower postoperative analgesic requirements and fewer micturition problems.

7. journals.lww.com journals.lww.com/rhaw/fulltext/2022/05030/to_compare_the_outcome_of_inguinal_hernia_repair.4.aspx

To compare the outcome of inguinal hernia repair under... When compared with the SA group, the LA group experienced much less post-operative pain. With local anesthesia, post-operative ambulation was substantially ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002961020305158

Using local rather than general anesthesia for inguinal ... Nordin et al. demonstrated that using local anesthesia reduced morbidity by 29%, unplanned admissions by 19%, and operative time and costs by 15%.

9. bmcsurg.biomedcentral.com bmcsurg.biomedcentral.com/articles/10.1186/s12893-025-02931-8

The feasibility and safety of ventral hernia repairs under local ... Overall, this study primarily demonstrates the feasibility, safety, and patient satisfaction for ventral hernia repair under local anaesthesia.