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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this interventional study is to learn if an Enhanced Recovery After Surgery (ERAS) protocol works to reduce the need for narcotic pain medications in live donor kidney transplant recipients. The main questions it aims to answer are: Does the ERAS protocol lower the amount of opioid narcotic medication needed to manage post-surgery pain? Does the ERAS protocol help lower pain scores after surgery? Researchers will compare the ERAS protocol to previous patients where the ERAS protocol was not used to see if the ERAS protocol works to reduce post-surgery pain. Participants will be asked to: * Drink a pre-surgery carbohydrate drink two hours before your surgery. * Take a pre-surgery dose of Tylenol by mouth. * Take a pre-surgery dose of Gabapentin by mouth. * The surgeon will administer a local numbing medication at the surgery site by injection during the surgery. * Begin walking with assistance about 12 hours after your surgery. * Allow the research staff to collect data about your kidney function. This data will be collected on your postoperative clinic visits, which generally occur about twice weekly for one month. This information will determine your kidney health, need for hospitalization, and side effects that may occur.

Research Team

Richard Ruiz, MD

Principal Investigator

Baylor Scott & White All Saints Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+