Clinical trial NCT03669081: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain, Postoperative
Keywords: live kidney donor
donor nephrectomy
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Cumulative Narcotic Use
timeFrame: 82.25 hours
measure: Length of Hospital Stay
timeFrame: 82.25 hours
Secondary outcomes:
measure: Serum Creatinine Levels at One Year Post-operatively
timeFrame: 1 year
measure: Bleeding Risk
timeFrame: 24 hours
measure: Number of Patients With Urinary Retention
timeFrame: 82.25 hours
measure: 30 Day Mortality
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
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.