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

Narcotic Use Clinical Trial

Official title:

Postoperative Pain Protocol Limiting Narcotics for Laparoscopic Hand-assisted Donor Nephrectomy Patients: A Randomized Control Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT06458842
• Other study ID #: 495511
• Status: Terminated
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Narcotic Use
• Pain, Postoperative
• Renal Transplant Donor of Left Kidney

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