Narcotic Use, Renal Transplant Donor of Left Kidney
Conditions
Brief summary
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.
Interventions
DRUGKetamine
OTHERPlacebo
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | number of days immediately after the surgery | length of stay after surgery |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| post surgical complication rates | 30 day |
| 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 |
| postoperative nausea | number of patients reporting postoperative nausea during inpatient time period |
Outcome results
None listed