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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT06458842
Other study ID # 495511
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 23, 2014
Est. completion date October 11, 2019

Study information

Verified date June 2024
Source Stony Brook University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 56
Est. completion date October 11, 2019
Est. primary completion date October 5, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ketamine

Other:
Placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Stony Brook University

Outcome

Type Measure Description Time frame Safety issue
Primary Length of hospital stay length of stay after surgery number of days immediately after the surgery
Secondary post surgical complication rates 30 day
Secondary postoperative renal function (serum creatinine) up to 2 years after intervention
Secondary amount of narcotic pain medication use starting immediately after the surgery, during the inpatient time period
Secondary postoperative nausea number of patients reporting postoperative nausea during inpatient time period
Secondary return of bowel function (passage of flatus) the number of days after surgery at which return of bowel function is achieved
Secondary date of postoperative ambulation reported during inpatient time period
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