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

NCT ID: NCT06458842

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-23
• Study Completion Date: 2019-10-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ketamine

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

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Ketamine

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

FRANK S. DARRAS MD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Darras, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook Medicine - Department of Urology

Other Identifiers

495511

Identifier Type: -

Identifier Source: org_study_id