Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669081
Recruitment Status : Completed
First Posted : September 13, 2018
Results First Posted : August 15, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey Campsen, University of Utah

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Ketorolac Drug: Pregabalin Drug: Placebo oral capsule Drug: Saline Phase 2

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: A Prospective, Double-blind, Randomized Pilot Study Evaluating the Effects of Toradol and Lyrica Verses Placebo for Pain Control After Donor Nephrectomy (TORPEDO)
Actual Study Start Date : September 20, 2016
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Toradol and Lyrica
Over-Encapsulated Pregabalin 75 mg was administered PO 30 minutes prior to operation; Ketorolac 30 mg IV x 1 was administered in the OR, followed by ketorolac 15 mg IV every 6 hours for 7 doses (or until discharge).
Drug: Ketorolac
Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively.
Other Name: Toradol

Drug: Pregabalin
Pregabalin was administered orally: 75 mg 30 minutes prior to operation.
Other Name: Lyrica

Placebo Comparator: Placebo and Standard of Care
Identical placebo oral capsule (same size and color) was administered PO 30 minutes prior to operation; Saline placebo IV x 1 was administered in the OR, followed by saline placebo IV every 6 hours for 7 doses. Standard of care practices maintained.
Drug: Placebo oral capsule
Placebo oral capsule was administered orally 30 minutes prior to operation.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Study Documents (Full-Text)

Documents provided by Jeffrey Campsen, University of Utah:
Statistical Analysis Plan  [PDF] October 31, 2017
Study Protocol  [PDF] July 3, 2019


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jeffrey Campsen, Associate Professor of Transplant Surgery, University of Utah
ClinicalTrials.gov Identifier: NCT03669081     History of Changes
Other Study ID Numbers: 00094756
First Posted: September 13, 2018    Key Record Dates
Results First Posted: August 15, 2019
Last Update Posted: August 15, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Jeffrey Campsen, University of Utah:
live kidney donor
donor nephrectomy
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ketorolac
Ketorolac Tromethamine
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors