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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Ketorolac
* Drug: Pregabalin
* Drug: Placebo oral capsule
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toradol and Lyrica<br>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<br>* Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively.<br>* Other names: Toradol;Drug: Pregabalin<br>* Pregabalin was administered orally: 75 mg 30 minutes prior to operation.<br>* Other names: Lyrica;|
| Placebo Comparator: Placebo and Standard of Care<br>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<br>* Placebo oral capsule was administered orally 30 minutes prior to operation.<br>Drug: Saline<br>* Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 82.25 hours | 
| Length of Hospital Stay | Primary outcomes include length of hospital stay (LOS). | 82.25 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Creatinine Levels at One Year Post-operatively | Renal function was evaluated by following serum creatinine levels for up to one year post-operatively. | 1 year | 
| Bleeding Risk | Hematocrit levels were evaluated post-operatively for up to a day post-operatively for signs of blood loss. | 24 hours | 
| Number of Patients With Urinary Retention | Patients were evaluated post-operatively during hospital stay for instances of urinary retention. | 82.25 hours | 
| 30 Day Mortality | Primary outcomes include 30 day mortality post-operatively. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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live kidney donor, donor nephrectomy