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

NCT06458842 | Terminated

• 1 other identifier: 495511
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Narcotic Use; Renal Transplant Donor of Left Kidney

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  length of stay after surgery

  number of days immediately after the surgery

Secondary Outcomes (6)

• 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

Study Arms (2)

Ketamine

EXPERIMENTAL

Patients in this group will receive ketamine, morphine PCA and caldolor for pain control

Drug: Ketamine

placebo

PLACEBO COMPARATOR

Patients in this group receive placebo, morphine PCA, and caldolor for pain control

Other: Placebo

Interventions

Ketamine DRUG

Ketamine

Placebo OTHER

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all individuals undergoing laparoscopic donor nephrectomies at Stony Brook Hospital

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stony Brook University: lead

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Frank Darras, MD

  Stony Brook Medicine - Department of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: June 14, 2024
• Study Start: May 23, 2014
• Primary Completion: October 5, 2019
• Study Completion: October 11, 2019
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share