General vs Spinal Anesthesia for Osteoarthritis

Overseen By Victor H Hernandez, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Pregnancy, Congestive heart failure, others

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

Compensation: Varies

Number of Visits: 1

Duration: Up to 2 hours

2396 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether general or spinal anesthesia is better for individuals undergoing total hip or knee replacement. Researchers aim to assess how each type affects recovery, including pain levels, hospital stay duration, and complications such as infections or implant issues. Individuals having their first hip or knee replacement surgery who speak English or Spanish may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance surgical outcomes for future patients.

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 study team or your doctor.

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

Research has shown that both general and spinal anesthesia are often used for joint surgeries, each with its own safety factors. General anesthesia is safe and effective, though some studies suggest it might cause more post-surgery pain compared to spinal anesthesia. However, it may help patients start moving sooner with less dizziness.

Spinal anesthesia is often noted for fewer blood transfusions, lower risks of blood clots, and fewer infections at the surgery site. Some research suggests it provides better overall results for joint surgeries than general anesthesia.

Both types of anesthesia have similar complication rates within 90 days after surgery, indicating they are safe and well-tolerated options for patients undergoing joint surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different anesthesia methods, specifically general versus spinal anesthesia, impact patients undergoing total joint arthroplasty (TJA) for osteoarthritis. While both methods are commonly used, understanding their effects on recovery, pain management, and overall outcomes can lead to more personalized and effective anesthesia choices. The trial aims to reveal which type of anesthesia might offer benefits like quicker recovery times or fewer side effects, ultimately enhancing the surgical experience for patients with osteoarthritis.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

This trial will compare the effects of general anesthesia and spinal anesthesia for joint replacement surgeries. Research has shown that both types of anesthesia are effective for these procedures. Participants receiving spinal anesthesia often experience shorter surgeries and reduced hospital stays, with a lower likelihood of needing to return to the hospital or undergo another surgery soon after. In contrast, participants receiving general anesthesia might begin moving sooner after surgery, but they may experience more pain afterward. Both anesthesia types are equally safe, so the choice typically depends on the patient's needs and preferences. ^{1 2 3 6 7}

Who Is on the Research Team?

Victor H Hernandez, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for individuals with osteoarthritis who are undergoing total joint arthroplasty (TJA). It's important that participants have not been excluded based on specific criteria set by the study, which could include factors like other medical conditions or previous treatments.

Inclusion Criteria

I am able to understand and agree to the study's procedures.

I am having my first hip or knee replacement surgery.

Exclusion Criteria

Patients with contraindications for general anesthesia such as: congestive heart failure, severe aortic stenosis, patient is unable/unwilling to consent, current pregnancy or women planning on becoming pregnant in the next year, and women who think they might be pregnant, or women who become pregnant during the study period will be removed from the study, prisoners

I cannot have spinal anesthesia due to certain health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total joint arthroplasty under either general or spinal anesthesia

Up to 2 hours

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for post-operative outcomes such as pain, nausea, and surgical site infections

Up to 72 hours

Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness, including infection, fracture, and readmission rates

90 days

What Are the Treatments Tested in This Trial?

Interventions

• General Anesthesia
• Spinal Anesthesia

Trial Overview The trial is comparing general anesthesia versus spinal anesthesia in patients having TJA. The focus is on measuring post-operative outcomes such as hospital stay duration, pain levels, nausea, infection rates at the surgical site, bone fractures near implants, implant dislocation, and necessity for additional surgeries or hospital readmissions.

How Is the Trial Designed?

Group I: Spinal Anesthesia Experimental Treatment 1 Intervention

Participants in this group will receive spinal anesthesia for TJA for up to 2 hours.

Group II: General Anesthesia Experimental Treatment 1 Intervention

Participants in this group will receive general anesthesia for TJA for up to 2 hours.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

In a study of 217,267 patients undergoing total joint arthroplasty, spinal anesthesia (SA) was associated with significantly lower rates of postoperative pneumonia (0.25% for SA vs. 0.39% for general anesthesia (GA)) and major complications (2.5% for SA vs. 3.2% for GA).

Patients classified as ASA 4 (those with severe systemic disease) had a notably higher risk of mortality with GA compared to SA, with mortality rates of 1.46% for GA versus 0.77% for SA, highlighting the safety benefits of SA in higher-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Pneumonia and Major Complications After Total Joint Arthroplasty With Spinal Versus General Anesthesia: A Propensity-matched Cohort Analysis. Harris, AB., Valenzuela, J., Andrade, N., et al.[2023]

In a study of 14,052 total knee arthroplasty cases, patients who received spinal anesthesia experienced significantly lower rates of complications, including superficial wound infections and blood transfusions, compared to those who received general anesthesia.

Spinal anesthesia was associated with shorter surgery times and hospital stays, and it particularly benefited patients with multiple preoperative comorbidities, suggesting it may be a safer option for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in short-term complications between spinal and general anesthesia for primary total knee arthroplasty. Pugely, AJ., Martin, CT., Gao, Y., et al.[2022]

In a study comparing 490 patients under general anesthesia (GA) and 746 patients under spinal anesthesia (SA) for total knee arthroplasty, GA was associated with longer preoperative and postoperative room times, as well as a longer hospital stay.

Patients receiving GA had a higher rate of surgical site infections (1% vs. 0%) and required more blood transfusions (41.8% vs. 35.1%) compared to those receiving SA, suggesting that SA may be a safer option for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Short-Term Complications of General and Spinal Anesthesia for Primary Unilateral Total Knee Arthroplasty. Park, YB., Chae, WS., Park, SH., et al.[2022]

In a study of 17,690 primary total knee arthroplasties, spinal anaesthesia was associated with significantly lower postoperative pain medication requirements and pain scores compared to general anaesthesia.

Patients receiving spinal anaesthesia experienced fewer complications, including lower rates of altered mental status and reduced 30- and 90-day readmissions, as well as a decreased risk of revision and reoperation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal versus general anaesthesia in contemporary primary total knee arthroplasties. Owen, AR., Amundson, AW., Larson, DR., et al.[2022]

In a study of 20,936 patients undergoing total hip arthroplasty, general anesthesia was linked to longer operating room times (+12 minutes) and increased postoperative room time (+5 minutes) compared to spinal anesthesia.

Patients receiving general anesthesia experienced a higher rate of adverse events, including a 31% increased risk of any adverse event and significantly higher odds of complications such as prolonged ventilator use and cardiac arrest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

General compared with spinal anesthesia for total hip arthroplasty. Basques, BA., Toy, JO., Bohl, DD., et al.[2022]

In a study of 11,680 patients undergoing total hip or knee arthroplasty, spinal anesthesia did not affect mortality rates up to 90 days post-surgery compared to general anesthesia, indicating similar safety profiles.

Patients receiving spinal anesthesia had lower rates of blood transfusions and were more likely to be discharged home after total knee arthroplasty, suggesting potential benefits in recovery and discharge efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative outcomes associated with general and spinal anesthesia after total joint arthroplasty for osteoarthritis: a large, Canadian, retrospective cohort study. Bourget-Murray, J., Halpenny, D., Mahdavi, S., et al.[2022]

In a study of 2,656 patients undergoing revision total hip arthroplasty, those who received spinal anesthesia experienced significantly shorter procedure times and less blood loss compared to those who received general anesthesia.

Patients under general anesthesia had higher odds of experiencing multiple in-hospital complications and longer hospital stays, indicating that spinal anesthesia may lead to better perioperative outcomes in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of Spinal Versus General Anesthesia in Revision Total Hip Arthroplasty: A Propensity Score-Matched Cohort Analysis. Tirumala, V., Bounajem, G., Klemt, C., et al.[2021]

In a study involving 1600 older adults undergoing hip fracture surgery, spinal anesthesia was found to be no more effective than general anesthesia in terms of survival and the ability to walk independently 60 days post-surgery.

The rates of postoperative delirium were similar between the two anesthesia types, indicating that neither method had a significant advantage regarding this complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Anesthesia or General Anesthesia for Hip Surgery in Older Adults. Neuman, MD., Feng, R., Carson, JL., et al.[2022]

Spinal anesthesia (SA) was found to be a safe and effective alternative to general anesthesia in 18 high-risk patients undergoing lumbar spine surgery, with no anesthetic or surgical complications reported.

Patients experienced excellent postoperative pain relief, low incidence of nausea (11.11%), and high satisfaction levels, while also benefiting from lower costs compared to general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lumbar Spine Surgeries Under Spinal Anesthesia in High-Risk Patients: A Retrospective Analysis. Patil, H., Garg, N., Navakar, D., et al.[2023]

In a study of 60 geriatric patients undergoing short transurethral surgeries, general anesthesia (GA) resulted in significantly shorter anesthesia preparation and surgery times compared to selective spinal anesthesia (SSA).

Despite the faster operational metrics in the GA group, both GA and SSA showed similar outcomes in terms of postoperative recovery, fast-track eligibility, and discharge times, indicating that SSA can be a safe alternative for outpatient procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of various anesthesia techniques on postoperative recovery and discharge criteria among geriatric patients. Ornek, D., Metin, S., Deren, S., et al.[2022]

In a study of 270,251 total knee arthroplasties, spinal anesthesia was associated with a significantly lower risk of prolonged hospital stays (greater than 3 days) and lower rates of 90-day readmission and revision compared to general anesthesia.

While spinal anesthesia resulted in a slightly longer operative time, its benefits in reducing complications support its use as part of enhanced recovery after surgery (ERAS) protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Versus General Anesthesia in Total Knee Arthroplasty: Are There Differences in Complication and Readmission Rates? Heckmann, ND., De, A., Porter, KR., et al.[2023]

Regional anesthesia for knee and hip surgeries may offer benefits such as better pain management, reduced bleeding, and lower risks of pulmonary and thromboembolic complications compared to general anesthesia, based on older studies and recent epidemiological data.

However, newer randomized trials show mixed results, and the lack of large, well-designed studies comparing modern general anesthesia with spinal anesthesia means that definitive recommendations cannot yet be made.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regional or general anesthesia for fast-track hip and knee replacement - what is the evidence? Kehlet, H., Aasvang, EK.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9343014/

Perioperative outcomes associated with general and spinal ... During fast-track arthroplasty pathways, general anesthesia may enable faster ambulation with less dizziness, but may compromise postoperative pain control. In ...

2. rapm.bmj.com rapm.bmj.com/content/early/2022/01/06/rapm-2021-103189

Neuraxial and general anesthesia for outpatient total joint ... Neuraxial anesthesia when compared with general anesthesia has shown to improve outcomes following lower extremity total joint arthroplasty.

3. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(24)00418-2/abstract

Morbidity and Mortality Following Total Hip and Knee ... Based upon these data, both SA and GA are reasonable options for primary TKA with similar risk profiles. However, GA may be associated with ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540317304424

Regional Anesthesia in Total Joint Arthroplasty Regional anesthesia has been associated with an 83% reduction in postoperative opioid consumption and decreased morbidity and mortality following hip surgery.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38788812/

The Use of General Anesthesia in Revision Joint Arthroplasty Results: Of the revision arthroplasty patients, 74.4% (632 of 850) were discharged on postoperative day 1 and 68.5% (582 of 850) of subjects were able to ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0949265822003190

Regional versus general anesthesia in knee arthroplasty ... A total of 78,275 patients were included for analysis; regional anesthesia showed a consistent protective effect from surgical site complications more ...

7. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(24)00516-3/abstract

The Use of General Anesthesia in Revision Joint Arthroplasty Several studies have suggested that spinal anesthesia gives superior outcomes for primary total joint arthroplasty (TJA). However, there is a lack of ...