Enhanced Recovery After Surgery (ERAS) in Live Donor Kidney Transplant Recipients
Part of paid clinical trials in Fort Worth, Texas.
- Sponsor
- Baylor Research Institute
- Study ID
- NCT06997016
- Phase
- PHASE4
- Status
- Enrolling By Invitation
Conditions
- Postoperative Pain
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- pre-operative carbohydrate drink — DIETARY_SUPPLEMENT50 g of carbohydrate drink 2 hours before surgery
- Acetaminophen — DRUG650mg acetaminophen 30 minutes prior to surgery
- Gabapentin — DRUG300 mg gabapentin 30 minutes prior to surgery
- Bupivacaine — DRUGintraoperative local anesthetic
- Ambulation — OTHERAssisted ambulation 12 hours after surgery
Study Details
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.
Key Dates
- Start date
- May 5, 2025
- Status verified
- May 2025
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Enhanced Recovery ProtocolThis 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
- No Intervention: Control groupThis 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.
Primary Outcome Measure
Numerical Rating Scale (NRS) (0-10) [ Time Frame: From enrollment to the end of treatment at 30 days ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Baylor Scott & White All Saints Medical Center | Fort Worth | Texas | 76104 | - |
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