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

NCT03669081 | Completed Phase 2 Results DMC

• 1 other identifier: 00094756
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain, Postoperative

Keywords

live kidney donor; donor nephrectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Serum Creatinine Levels at One Year Post-operatively

  1 year

• Bleeding Risk

  24 hours

• Number of Patients With Urinary Retention

  82.25 hours

• 30 Day Mortality

  30 days

Study Arms (2)

Toradol and Lyrica

EXPERIMENTAL

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; Drug: Pregabalin

Placebo and Standard of Care

PLACEBO COMPARATOR

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; Drug: Saline

Interventions

Ketorolac DRUG

Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively.

Also known as: Toradol

Toradol and Lyrica

Pregabalin DRUG

Pregabalin was administered orally: 75 mg 30 minutes prior to operation.

Also known as: Lyrica

Toradol and Lyrica

Placebo oral capsule DRUG

Placebo oral capsule was administered orally 30 minutes prior to operation.

Placebo and Standard of Care

Saline DRUG

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

Placebo and Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients anticipating donating a kidney in a live kidney donor transplant.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Related Publications (1)

• 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.

  PMID: 30589514 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketorolac; Ketorolac Tromethamine; Pregabalin; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Eryberto Martinez
• Organization: University of Utah

eddie.martinez@utah.edu

801-581-2563

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Transplant Surgery

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 13, 2018
• Study Start: September 20, 2016
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: August 15, 2019
• Results First Posted: August 15, 2019

Record last verified: 2019-07