Postoperative Pain Protocol Limiting Narcotics for Laparoscopic Hand-assisted Donor Nephrectomy

Postoperative Pain Protocol Limiting Narcotics for Laparoscopic Hand-assisted Donor Nephrectomy Patients: A Randomized Control Trial

Kidney donors represent healthy patients and their anticipated postoperative course should be uncomplicated and brief. This study looks to optimize the perioperative pain regimen of laparoscopic donor nephrectomy patients by minimizing or eliminating narcotics from the immediate post-operative period. Current postoperative standard of care after donor nephrectomy require narcotic analgesics. While narcotics are potent pain medications, they are often associated with complications including nausea, vomiting and dysfunction of the gastrointestinal tract causing prolonged complications.

The investigators seek to evaluate a peri-operative pain regimen limiting the usage of narcotics. This incorporates a perioperative analgesic course utilizing combination of an intravenous non-steroidal anti-inflammatory drug (NSAID), intravenous acetaminophen, and intravenous ketamine. All three have been demonstrated to be effective for the control of perioperative pain while decreasing narcotics use.

Prior to surgery, participants will be consented and randomly assigned to receive the standard of care perioperative pain management using intravenous narcotics as a patient-controlled analgesia (PCA) by itself plus placebo or along with the new protocol. The study will demonstrate it the new protocol will limit or eliminate the need for narcotics as a patient-controlled dose during the postoperative period.

Upon discharge from the hospital, patients will be followed in clinic and via home questionnaires annually for 5 years to evaluate satisfaction, renal function and quality of life.

Study Overview

• Status: Terminated
• Conditions: Narcotic Use; Renal Transplant Donor of Left Kidney
• Intervention / Treatment: Other: Placebo; Drug: Ketamine

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• all individuals undergoing laparoscopic donor nephrectomies at Stony Brook Hospital

Exclusion Criteria:

• Patients excluded as a potential kidney donor or surgical candidate (renal failure, cancer, uncontrolled hypertension or diabetes, cognitively impaired adults, children, history of stroke, complicated coronary history or pregnant)
• Patients with a history of chronic pain or chronic pain medication use
• Patients who are undergoing open nephrectomies
• Allergy to NSAID or acetaminophen
• Hepatic disease or elevated transaminases
• Peptic Ulcer Disease
• Probenecid use
• History of traumatic brain injury
• Contraindications of Ketamine Use (recent head trauma, open eye injury or glaucoma)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketamine; Patients in this group will receive ketamine, morphine PCA and caldolor for pain control	Drug: Ketamine
Placebo Comparator: placebo; Patients in this group receive placebo, morphine PCA, and caldolor for pain control	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	length of stay after surgery	number of days immediately after the surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
post surgical complication rates	30 day
postoperative renal function (serum creatinine)	up to 2 years after intervention
amount of narcotic pain medication use	starting immediately after the surgery, during the inpatient time period
postoperative nausea	number of patients reporting postoperative nausea during inpatient time period
return of bowel function (passage of flatus)	the number of days after surgery at which return of bowel function is achieved
date of postoperative ambulation	reported during inpatient time period

Collaborators and Investigators

• Sponsor: Stony Brook University
• Investigators: Principal Investigator: Frank Darras, MD, Stony Brook Medicine - Department of Urology

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2014
• Primary Completion (Actual): October 5, 2019
• Study Completion (Actual): October 11, 2019

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: 495511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No