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

Pain, Postoperative Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669081
• Other study ID #: 00094756
• Status: Completed
• Phase: Phase 2
• Start date: September 20, 2016
• Est. completion date: September 30, 2018

Study information

• Verified date: July 2019
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Ketorolac
Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively.
• Pregabalin
Pregabalin was administered orally: 75 mg 30 minutes prior to operation.
• Placebo oral capsule
Placebo oral capsule was administered orally 30 minutes prior to operation.
• Saline
Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Length of Hospital Stay	Primary outcomes include length of hospital stay (LOS).	82.25 hours
Secondary	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
Secondary	Bleeding Risk	Hematocrit levels were evaluated post-operatively for up to a day post-operatively for signs of blood loss.	24 hours
Secondary	Number of Patients With Urinary Retention	Patients were evaluated post-operatively during hospital stay for instances of urinary retention.	82.25 hours
Secondary	30 Day Mortality	Primary outcomes include 30 day mortality post-operatively.	30 days