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Enrolling by invitation NCT06997016

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

Phase IV Interventional Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pre-operative carbohydrate drink, Acetaminophen, Gabapentin, Bupivacaine.
Who it may be relevant to
Registry conditions: Postoperative Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Dietary supplement pre-operative carbohydrate drink
    50 g of carbohydrate drink 2 hours before surgery
  • Drug Acetaminophen
    650mg acetaminophen 30 minutes prior to surgery
  • Drug Gabapentin
    300 mg gabapentin 30 minutes prior to surgery
  • Drug Bupivacaine
    intraoperative local anesthetic
  • Other Ambulation
    Assisted ambulation 12 hours after surgery

Primary outcome measures

  • Numerical Rating Scale (NRS) (0-10) [Time frame: From enrollment to the end of treatment at 30 days]
  • Narcotic Use [Time frame: From enrollment to the end of treatment at 30 days]
Secondary outcome measures (3)
  • Adverse Events [Time frame: From enrollment to the end of treatment at 30 days]
  • Hospital readmission [Time frame: From enrollment to the end of treatment at 30 days]
  • Length of Stay [Time frame: From enrollment to the end of treatment at 30 days]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Baylor Scott & White All Saints Medical Center — Fort Worth

Identifiers

NCT: NCT06997016 · Baylor IRB #025-220

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗