Clinical trial NCT06458842: Postoperative Pain Protocol Limiting Narcotics for Laparoscopic Hand-assisted Donor Nephrectomy
Official title: Postoperative Pain Protocol Limiting Narcotics for Laparoscopic Hand-assisted Donor Nephrectomy Patients: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Narcotic Use
Renal Transplant Donor of Left Kidney
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Length of hospital stay
timeFrame: number of days immediately after the surgery
Secondary outcomes:
measure: post surgical complication rates
timeFrame: 30 day
measure: postoperative renal function (serum creatinine)
timeFrame: up to 2 years after intervention
measure: amount of narcotic pain medication use
timeFrame: starting immediately after the surgery, during the inpatient time period
measure: postoperative nausea
timeFrame: number of patients reporting postoperative nausea during inpatient time period
measure: return of bowel function (passage of flatus)
timeFrame: the number of days after surgery at which return of bowel function is achieved
measure: date of postoperative ambulation
timeFrame: reported during inpatient time period
Other outcomes:
Locations:
Study officials:
affiliation: Stony Brook Medicine - Department of Urology
name: Frank Darras, MD
role: PRINCIPAL_INVESTIGATOR
References: