TerminatedN/Aketamine

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

Sponsored by Stony Brook University

NCT ID
NCT06458842
Target Enrollment
56 participants
Start Date
2014-05-23
Est. Completion
2019-10-11

About This Study

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 Studied

Narcotic UseRenal Transplant Donor of Left Kidney

Interventions

  • Ketamine
  • Placebo

Eligibility

Age:18 Years - N/A
Healthy Volunteers:Yes
View full 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)

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source

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