Enhanced Recovery After Surgery (ERAS) in Live Donor Kidney Transplant Recipients

Phase 4

Not yet recruiting

• Conditions: Postoperative Pain
• Interventions: Dietary Supplement: pre-operative carbohydrate drink; Drug: Acetaminophen; Drug: Gabapentin; Drug: Bupivacaine; Other: Ambulation

• Registration Number: NCT06997016
• Lead Sponsor: Baylor Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-21
• Study First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Study First Posted: 2025-05-30
• Last Update Posted: 2025-05-30
• Study Start: 2025-06
• Primary Completion: 2026-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Adult patients, over 18 years of age, receiving a kidney transplant from a living donor.

Exclusion Criteria

• delayed gastric emptying, severe type I diabetes, allergy to interventional medications, pregnancy (this is a normal exclusion for kidney recipients)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enhanced Recovery Protocol	Bupivacaine	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
Enhanced Recovery Protocol	Ambulation	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
Enhanced Recovery Protocol	Gabapentin	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
Enhanced Recovery Protocol	Acetaminophen	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
Enhanced Recovery Protocol	pre-operative carbohydrate drink	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

Primary Outcome Measures

Name	Time	Method
Pain Scores	From enrollment to the end of treatment at 30 days	Routinely recorded pain scores from EMR
Narcotic Use	From enrollment to the end of treatment at 30 days	milligram morphine equivalents (MME)

Secondary Outcome Measures

Name	Time	Method
Adverse Events	From enrollment to the end of treatment at 30 days
Hospital readmission	From enrollment to the end of treatment at 30 days	readmission to any hospital within 30 days
Length of Stay	From enrollment to the end of treatment at 30 days	total hospital length of stay

Trial Locations

Locations (1)

Baylor Scott & White All Saints Medical Center; 🇺🇸 Fort Worth, Texas, United States