Enhanced Recovery Protocol for Postoperative Pain

Overseen By GME Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Baylor Research Institute

Must be taking: Tylenol, Gabapentin

Disqualifiers: Delayed gastric emptying, Type I diabetes, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to reduce pain after live donor kidney transplants. Researchers aim to determine if the Enhanced Recovery After Surgery (ERAS) protocol can decrease the need for narcotic painkillers and improve post-surgery pain levels. Participants will follow a specific plan, including taking certain medications before surgery and beginning to walk soon after. Individuals who have received a kidney from a living donor might be suitable candidates. As a Phase 4 trial, this research seeks to understand how an already FDA-approved and effective treatment can benefit more patients.

Do I need to stop my current medications for the trial?

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

What is the safety track record for the Enhanced Recovery After Surgery (ERAS) protocol?

Research has shown that Enhanced Recovery After Surgery (ERAS) plans are generally safe and effective for patients. Those who followed an ERAS plan spent less time in the hospital, with stays decreasing from an average of seven days to five days, and reported greater satisfaction after surgery. One study found that patients on an ERAS plan used 50% less opioid pain medication post-surgery without experiencing increased pain.

These findings suggest that the ERAS plan can reduce pain and speed up recovery without adding extra risks. The steps in the ERAS plan, such as taking Tylenol and Gabapentin before surgery, are common and usually safe. The local numbing injection used during surgery is also a standard method for managing pain.

Overall, the ERAS approach appears to be a safe way to enhance recovery after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Enhanced Recovery Protocol for postoperative pain because it aims to streamline and improve recovery after surgery, especially for kidney transplant patients. Unlike traditional methods that often rely heavily on postoperative opioids, this protocol incorporates a multi-modal approach including a carbohydrate drink, gabapentin, acetaminophen, and local anesthetic, which are all administered before or during surgery. This combination is expected to reduce pain, speed up recovery, and minimize opioid use, making recovery safer and more comfortable for patients. Plus, the protocol encourages early mobilization, which is crucial for improved outcomes.

What evidence suggests that the Enhanced Recovery After Surgery protocol is effective for reducing postoperative pain in kidney transplant recipients?

Research has shown that the Enhanced Recovery After Surgery (ERAS) plan can significantly reduce the need for opioid pain medications post-surgery. One study found that ERAS decreased opioid use and its side effects. Another study discovered that ERAS shortened hospital stays by about 2.5 days, indicating quicker recovery. ERAS also reduced the chances of complications and infections after surgery. These findings support ERAS's effectiveness in managing pain and improving recovery post-surgery. Participants in this trial will join either the Enhanced Recovery Protocol group, receiving specific pre- and post-operative interventions, or the Control group, which involves a retrospective review of past patients. ^{2 3 6 7 8}

Who Is on the Research Team?

Richard Ruiz, MD

Principal Investigator

Baylor Scott & White All Saints Medical Center

Are You a Good Fit for This Trial?

This trial is for live donor kidney transplant recipients looking to manage post-surgery pain. Participants must be willing to follow the ERAS protocol, which includes pre-operative drinks and medications, a local anesthetic during surgery, and early postoperative ambulation.

Inclusion Criteria

I am over 18 and getting a kidney transplant from a living donor.

Exclusion Criteria

History of severe type I diabetes

Allergy to interventional medications

Pregnancy (this is a normal exclusion for kidney recipients)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Preparation

Participants receive a carbohydrate drink, Tylenol, and Gabapentin before surgery

1 day

1 visit (in-person)

Surgery and Immediate Recovery

Participants undergo surgery with local anesthetic and begin assisted ambulation 12 hours post-surgery

1-2 days

Postoperative Monitoring

Data collection on kidney function and monitoring for side effects during postoperative clinic visits

4 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Recovery After Surgery (ERAS)

Trial Overview The study tests if the ERAS protocol can reduce opioid use and lower pain scores after kidney transplant surgery. It involves pre-surgery carbohydrate drinks, Tylenol, Gabapentin, Bupivacaine injections during surgery, and early walking post-surgery compared to past non-ERAS methods.

How Is the Trial Designed?

Group I: Enhanced Recovery Protocol Experimental Treatment 5 Interventions

This group will receive the following: 50g carbohydrate drink 2 hours prior to surgery 300mg of gabapentin 30 minutes prior to surgery 650mg of acetaminophen 30 minutes prior to surgery 0.25% bupivicaine local anesthetic intraoperatively assisted ambulation 12 hours after surgery

Group II: Control group Active Control 1 Intervention

This group is a retrospective review of 30 patients who have undergone a live donor kidney transplant during 1/1/2022-12/31/2024 will be selected and undergo a retrospective chart review for the same data collection points.

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6738505/

Evaluation of the effectiveness of an enhanced recovery after ... Implementation of ERAS was associated with an absolute reduction of 12% in postoperative complications and a significant reduction in surgical site infections ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1091255X24007765

Effectiveness of Enhanced Recovery After Surgery protocol ... This meta-analysis demonstrated that the ERAS protocol significantly reduces the LOS by an average of 2.49 days and hospital costs by 0.36 SMD in patients who ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820097

Enhanced Recovery After Surgery Guidelines and Hospital ... Several surgery-specific systematic reviews have found positive or mixed effects on outcomes after adopting ERAS guidelines. However, a ...

4. journals.lww.com journals.lww.com/clinicalpain/fulltext/2020/03000/enhanced_recovery_after_surgery__eras___a.11.aspx

Enhanced Recovery After Surgery (ERAS): A Perspective... ... The objective of this study was to review the current scientific evidence on the role of Enhanced Recovery After Surgery (ERAS) implementations in reducing ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35746820/

The effectiveness of ERAS guidelines in reducing ... Enhanced recovery after surgery (ERAS) guidelines have shown promise in reducing opioid exposure and minimizing opioid-related side effects.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10654132/

Enhanced Recovery After Surgery: Exploring the Advances ... This included a shorter average hospital stay (reduced from seven days to five days) and greater postoperative patient satisfaction [23].

7. sciencedirect.com sciencedirect.com/science/article/pii/S1365182X2200137X

Impact of an enhanced recovery after surgery protocol on ... Implementation of an ERAS protocol was associated with a significant reduction in postoperative LOS in both elderly and non-elderly patients.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9975314/

Impact of Enhanced Recovery After Surgery pathway for ... Inpatient postoperative opioid use decreased by 50% after the implementation of an ERAS protocol, without an increase in postoperative pain scores. The ...