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

Baylor Scott and White Health (BSWH)

Status and phase: Invitation-only; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Gabapentin; Dietary Supplement: pre-operative carbohydrate drink; Other: Ambulation; Drug: Bupivacaine; Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT06997016

Baylor IRB #025-220

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Enhanced Recovery Protocol

Experimental group

Description:

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

Treatment:

Drug: Acetaminophen

Drug: Bupivacaine

Other: Ambulation

Drug: Gabapentin

Dietary Supplement: pre-operative carbohydrate drink

Control group

No Intervention group

Description:

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.