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Procedure
Donor nephrectomy for Opioid Use Disorder
N/A
Recruiting
Led By Uzong Yoon, MD, MPH
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from arrival to pacu until post-operative day 2 (48 hours)
Awards & highlights
Study Summary
This trial is designed to study the effectiveness of an ERAS pathway for patients undergoing living donor nephrectomy. The hypothesis is that this will lead to faster recovery, early bowel function, decreased postoperative pain, increased patient satisfaction and shorter length of stay.
Eligible Conditions
- Opioid Use Disorder
- Postoperative Complications
- Kidney Disease
- Postoperative Pain
- Postoperative Nausea and Vomiting
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from arrival to pacu until post-operative day 2 (48 hours)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from arrival to pacu until post-operative day 2 (48 hours)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
post operative opioid consumption
Secondary outcome measures
duration of hospitalization
patient satisfaction
time to first oral intake
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced recovery after surgeryExperimental Treatment5 Interventions
Preoperatively, patients will be counseled on optimization of physical and nutritional status. They will receive carbohydrate loading drinks prior to surgery. Intraoperatively, standard ASA monitors will be utilized, and patients will receive general anesthesia. Goal directed fluid management will be enforced with bolus options based on hemodynamics. Transabdominal plane and rectus sheath block will be performed in the operating room by the regional anesthesia team. Post-operatively pain management will include multimodal analgesic medications. Regular diet will be allowed and encouraged on post-operative day 0 (POD). Lines and drains will be minimized to encourage early mobilization and bowel function. Patients will be counseled on expectations of discharge criteria POD0.
Group II: Standard of careActive Control1 Intervention
Patients will receive traditional care for donor nephrectomy. Patients will be instructed to fast for 24 hours preoperative. On day of surgery, standard monitors will be used, and intraoperative management per anesthesiologists discretion including pain management. Post-operative, patients will receive pain medications, including opioids, as needed. Intravenous fluids will be continued until patients tolerate liquids per os. Bowel regimen will be ordered as needed. Patients will be discharged once meeting pre-set criteria.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
regional anesthesia
2009
Completed Phase 3
~64310
Find a Location
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
444 Previous Clinical Trials
145,582 Total Patients Enrolled
Uzong Yoon, MD, MPHPrincipal InvestigatorThomas Jefferson University
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are being recruited for this research endeavor?
"Affirmative, the details of this clinical trial hosted on clinicaltrials.gov demonstrate that patient recruitment is currently underway. It was initially posted in September 12th 2019 and last updated April 27th 2022; 42 participants are needed at one site."
Answered by AI
Are there any openings for this clinical trial at the moment?
"Affirmative. Clinicaltrials.gov's data states that this medical trial, which began recruiting on September 12th 2019, is currently seeking participants. 42 patients are needed from a single research site."
Answered by AI
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