Study Evaluating the Effects of Toradol and Lyrica for Pain Control After Donor Nephrectomy
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ketorolac
Pregabalin
Placebo oral capsule
Saline
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative focused on measuring live kidney donor, donor nephrectomy
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Toradol and Lyrica
Placebo and Standard of Care
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Cumulative Narcotic Use
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.
Length of Hospital Stay
Primary outcomes include length of hospital stay (LOS).
Secondary Outcome Measures
Serum Creatinine Levels at One Year Post-operatively
Renal function was evaluated by following serum creatinine levels for up to one year post-operatively.
Bleeding Risk
Hematocrit levels were evaluated post-operatively for up to a day post-operatively for signs of blood loss.
Number of Patients With Urinary Retention
Patients were evaluated post-operatively during hospital stay for instances of urinary retention.
30 Day Mortality
Primary outcomes include 30 day mortality post-operatively.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03669081
Brief Title
Study Evaluating the Effects of Toradol and Lyrica for Pain Control After Donor Nephrectomy
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 20, 2016 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
live kidney donor, donor nephrectomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Toradol and Lyrica
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo and Standard of Care
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively.
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
Pregabalin was administered orally: 75 mg 30 minutes prior to operation.
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Placebo oral capsule was administered orally 30 minutes prior to operation.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively.
Primary Outcome Measure Information:
Title
Cumulative Narcotic Use
Description
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.
Time Frame
82.25 hours
Title
Length of Hospital Stay
Description
Primary outcomes include length of hospital stay (LOS).
Time Frame
82.25 hours
Secondary Outcome Measure Information:
Title
Serum Creatinine Levels at One Year Post-operatively
Description
Renal function was evaluated by following serum creatinine levels for up to one year post-operatively.
Time Frame
1 year
Title
Bleeding Risk
Description
Hematocrit levels were evaluated post-operatively for up to a day post-operatively for signs of blood loss.
Time Frame
24 hours
Title
Number of Patients With Urinary Retention
Description
Patients were evaluated post-operatively during hospital stay for instances of urinary retention.
Time Frame
82.25 hours
Title
30 Day Mortality
Description
Primary outcomes include 30 day mortality post-operatively.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
30589514
Citation
Campsen J, Call T, Allen CM, Presson AP, Martinez E, Rofaiel G, Kim RD. Prospective, double-blind, randomized clinical trial comparing an ERAS pathway with ketorolac and pregabalin versus standard of care plus placebo during live donor nephrectomy for kidney transplant. Am J Transplant. 2019 Jun;19(6):1777-1781. doi: 10.1111/ajt.15242. Epub 2019 Jan 28.
Results Reference
derived
Learn more about this trial
Study Evaluating the Effects of Toradol and Lyrica for Pain Control After Donor Nephrectomy
We'll reach out to this number within 24 hrs