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

NCT ID: NCT03669081

Last Updated: 2019-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-20
• Study Completion Date: 2018-09-30

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Placebo and Standard of Care

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.

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

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

Saline

Intervention Type: DRUG

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

Toradol and Lyrica

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).

Group Type: EXPERIMENTAL

Ketorolac

Intervention Type: DRUG

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

Pregabalin

Intervention Type: DRUG

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

Interventions

Ketorolac

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

Intervention Type: DRUG

Pregabalin

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

Intervention Type: DRUG

Placebo oral capsule

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

Intervention Type: DRUG

Saline

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

Intervention Type: DRUG

Other Intervention Names

Toradol; Lyrica

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Campsen

Associate Professor of Transplant Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 30589514 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

00094756

Identifier Type: -

Identifier Source: org_study_id