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

NCT ID: NCT06997016

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-05

Study Completion Date

2027-06-30

Brief Summary

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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

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Enhanced Recovery Protocol

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 Type EXPERIMENTAL

pre-operative carbohydrate drink

Intervention Type DIETARY_SUPPLEMENT

50 g of carbohydrate drink 2 hours before surgery

Acetaminophen

Intervention Type DRUG

650mg acetaminophen 30 minutes prior to surgery

Gabapentin

Intervention Type DRUG

300 mg gabapentin 30 minutes prior to surgery

Bupivacaine

Intervention Type DRUG

intraoperative local anesthetic

Ambulation

Intervention Type OTHER

Assisted ambulation 12 hours after surgery

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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pre-operative carbohydrate drink

50 g of carbohydrate drink 2 hours before surgery

Intervention Type DIETARY_SUPPLEMENT

Acetaminophen

650mg acetaminophen 30 minutes prior to surgery

Intervention Type DRUG

Gabapentin

300 mg gabapentin 30 minutes prior to surgery

Intervention Type DRUG

Bupivacaine

intraoperative local anesthetic

Intervention Type DRUG

Ambulation

Assisted ambulation 12 hours after surgery

Intervention Type OTHER

Other Intervention Names

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tylenol Neurontin Gralise Marcaine Sensorcaine

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Ruiz, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Scott & White All Saints Medical Center

Locations

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Baylor Scott & White All Saints Medical Center

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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Baylor IRB #025-220

Identifier Type: -

Identifier Source: org_study_id

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