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

Stony Brook University

Status

Terminated

Conditions

Renal Transplant Donor of Left Kidney

Narcotic Use

Treatments

Other: Placebo

Drug: Ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT06458842

495511

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)