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

NCT06458842 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2024-06-14

No results posted yet for this study

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

Interventions

DRUG

Ketamine

OTHER

Placebo

Sponsors & Collaborators

Principal Investigators

  • Frank Darras, MD · Stony Brook Medicine - Department of Urology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-23
Primary Completion
2019-10-05
Completion
2019-10-11

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06458842 on ClinicalTrials.gov