Skip to main content
OpenTrials
Completed

NCT Number: NCT03669081

Study Evaluating the Effects of Toradol and Lyrica for Pain Control After Donor Nephrectomy

The investigators will assess how the use of toradol and pregabalin affects return to bowel function and see if there is a difference in length of hospital stay. Narcotic use can affect bowel function so the investigators hypothesize that use of Toradol will decrease delayed bowel function and aid in a patients discharge and reduction of hospital stay.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

Perioperative pain management is a significant challenge following surgery. Many pathways contribute to perioperative pain, including nociceptive, inflammatory, and neuropathic sources. Although opioids have long been a mainstay for perioperative analgesia, other non-opioid therapies have been increasingly used as part of a multimodal analgesic regimen to provide improved pain control while minimizing opioid-related side effects

TORADOL (ketorolac tromethamine), is a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level.

Anecdotal evidence has shown that the use of Toradol (Ketorolac) is safe in renal surgery patients. The study team aims to further evaluate this in a pilot study specifically in the population of patient who have donated their kidney in live kidney transplants. The study team will assess how the use of toradol affects return to bowel function and see if there is a difference in length of hospital stay. Narcotic use can affect bowel function so the investigators hypothesize that use of Toradol will decrease delayed bowel function and aid in a patients discharge and reduction of hospital stay. The study team will assess differences in visual analog pain scores and total narcotic consumption, whereas secondary endpoints of urine output, serum creatinine and hemoglobin levels to assess for efficacy and safety.

Pregabalin is prescribed for neuropathic pain. In many studies, preoperative administration of pregabalin reduced postoperative morphine consumption and early postoperative pain.

There will be two arms of the study including:

Arm 1 (pure placebo group): Placebo oral preop then Saline placebo IV x 1 in the OR, then saline placebo IV every 6 hours for 7 doses.

Arm 2: Pregabalin 75mg oral preop, then Ketorolac 30 mg IV x 1 in the OR, then ketorolac 15 mg IV every 6 hours for 7 doses.

Toradol and Lyrica will be used consistent with its FDA approval in terms of dosing, route of administration, etc.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients anticipating donating a kidney in a live kidney donor transplant.

Exclusion criteria

  • Patients not receiving a donor nephrectomy
  • Pregnant, lactating, or nursing mothers
  • Medical allergies or history that would otherwise be contraindicated for of a non-steroidal anti-inflammatory drug.

Treatment and study plan

Ketorolac

Drug

Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively.

Other names: Toradol

Pregabalin

Drug

Pregabalin was administered orally: 75 mg 30 minutes prior to operation.

Other names: Lyrica

Placebo oral capsule

Drug

Placebo oral capsule was administered orally 30 minutes prior to operation.

Saline

Drug

Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively.

Primary outcomes

  1. Cumulative Narcotic Use

    Time frame: 82.25 hours

    Cumulative narcotic use was defined by cumulative morphine equivalents over the course of a patient's hospital course. The Washington State Agency Medical Director's Group Opioid dose calculator was used to provide a total morphine dose equivalent (MDE) for each patient while in the hospital.

  2. Length of Hospital Stay

    Time frame: 82.25 hours

    Primary outcomes include length of hospital stay (LOS).

Secondary outcomes

  1. Serum Creatinine Levels at One Year Post-operatively

    Time frame: 1 year

    Renal function was evaluated by following serum creatinine levels for up to one year post-operatively.

  2. Bleeding Risk

    Time frame: 24 hours

    Hematocrit levels were evaluated post-operatively for up to a day post-operatively for signs of blood loss.

  3. Number of Patients With Urinary Retention

    Time frame: 82.25 hours

    Patients were evaluated post-operatively during hospital stay for instances of urinary retention.

  4. 30 Day Mortality

    Time frame: 30 days

    Primary outcomes include 30 day mortality post-operatively.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

A Prospective, Double-blind, Randomized Pilot Study Evaluating the Effects of Toradol and Lyrica Verses Placebo for Pain Control After Donor Nephrectomy (TORPEDO)

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2018
Registry last updated
Aug 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.