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

NCT06997016 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: Baylor IRB #025-220
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

transplantation, kidney; renal transplantation; Enhanced Postsurgical Recovery; Recovery, Enhanced Postsurgical; pain, postoperative; postsurgical pain

Outcome Measures

Primary Outcomes (2)

• Numerical Rating Scale (NRS) (0-10)

  Patient reported pain on a scale from 0 (no pain) to 10 (the worst possible pain)

  From enrollment to the end of treatment at 30 days

• Narcotic Use

  milligram morphine equivalents (MME)

  From enrollment to the end of treatment at 30 days

Secondary Outcomes (3)

• Adverse Events

  From enrollment to the end of treatment at 30 days

• Hospital readmission

  From enrollment to the end of treatment at 30 days

• Length of Stay

  From enrollment to the end of treatment at 30 days

Study Arms (2)

Enhanced Recovery Protocol

EXPERIMENTAL

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

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

Control group

NO 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.

Interventions

Acetaminophen DRUG

650mg acetaminophen 30 minutes prior to surgery

Also known as: tylenol

Enhanced Recovery Protocol

Gabapentin DRUG

300 mg gabapentin 30 minutes prior to surgery

Also known as: Neurontin, Gralise

Enhanced Recovery Protocol

Bupivacaine DRUG

intraoperative local anesthetic

Also known as: Marcaine, Sensorcaine

Enhanced Recovery Protocol

Ambulation OTHER

Assisted ambulation 12 hours after surgery

Enhanced Recovery Protocol

pre-operative carbohydrate drink DIETARY_SUPPLEMENT

50 g of carbohydrate drink 2 hours before surgery

Enhanced Recovery Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• delayed gastric emptying
• severe type I diabetes
• allergy to interventional medications

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (1)

Baylor Scott & White All Saints Medical Center

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Gabapentin; Bupivacaine; Walking

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Richard Ruiz, MD

  Baylor Scott & White All Saints Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)