Narcotic UseNCT06458842
Postoperative Pain Protocol Limiting Narcotics for Laparoscopic Hand-assisted Donor Nephrectomy
A study testing Ketamine in people with Narcotic Use and Renal Transplant Donor of Left Kidney, run by Stony Brook University.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Narcotic Use, Renal Transplant Donor of Left Kidney
- What is being tested?
- Ketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 23 May 2014to 11 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all individuals undergoing laparoscopic donor nephrectomies at Stony Brook Hospital
Who cannot join
- 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
Show all 9Show fewer
- Probenecid use
- History of traumatic brain injury
- Contraindications of Ketamine Use (recent head trauma, open eye injury or glaucoma)
About this study
Official title: Postoperative Pain Protocol Limiting Narcotics for Laparoscopic Hand-assisted Donor Nephrectomy Patients: A Randomized Control Trial
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.
Read more
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.
- Being tested
- Ketamine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | Patients in this group will receive ketamine, morphine PCA and caldolor for pain control Receives: Drug: Ketamine |
| placebo | Placebo comparator | Patients in this group receive placebo, morphine PCA, and caldolor for pain control Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
length of stay after surgery
Measured: number of days immediately after the surgery
Secondary outcomes (6)
post surgical complication rates
Measured: 30 day
postoperative renal function (serum creatinine)
Measured: up to 2 years after intervention
amount of narcotic pain medication use
Measured: starting immediately after the surgery, during the inpatient time period
postoperative nausea
Measured: number of patients reporting postoperative nausea during inpatient time period
return of bowel function (passage of flatus)
Measured: the number of days after surgery at which return of bowel function is achieved
date of postoperative ambulation
Measured: reported during inpatient time period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start23 May 2014
- Primary completion5 Oct 2019
- Study completion11 Oct 2019
Why it stopped: Unable to recruit desired number of patients in reasonable time frame
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Narcotic UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FRANK S. DARRAS MD, Stony Brook University
- Investigators
- Frank Darras, MD, Principal investigator, Stony Brook Medicine - Department of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458842
- Sponsor's protocol ID
- 495511
- Status last verified
- Jun 2024
- First submitted
- 17 May 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Protocol Limiting Narcotics for Laparoscopic Hand-assisted Donor Nephrectomy Patients: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06458842
- Acronym / sponsor ID
- 495511
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit desired number of patients in reasonable time frame
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 23 May 2014 (actual)
- Primary completion
- 5 Oct 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: KetaminePatients in this group will receive ketamine, morphine PCA and caldolor for pain control |
| placebo | Placebo comparator | Other: PlaceboPatients in this group receive placebo, morphine PCA, and caldolor for pain control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all individuals undergoing laparoscopic donor nephrectomies at Stony Brook Hospital
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine | Drug | Ketamine |
| Placebo | Other | placebo |
Primary outcome
Length of hospital stay
Time frame: number of days immediately after the surgery
length of stay after surgery
6 secondary outcomes
post surgical complication rates
Time frame: 30 day
postoperative renal function (serum creatinine)
Time frame: up to 2 years after intervention
amount of narcotic pain medication use
Time frame: starting immediately after the surgery, during the inpatient time period
postoperative nausea
Time frame: number of patients reporting postoperative nausea during inpatient time period
return of bowel function (passage of flatus)
Time frame: the number of days after surgery at which return of bowel function is achieved
date of postoperative ambulation
Time frame: reported during inpatient time period
Results and safety
The study was stopped early (reason given: Unable to recruit desired number of patients in reasonable time frame). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Darras, MD principal investigator
Stony Brook Medicine - Department of Urology
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine in people with Narcotic Use and Renal Transplant Donor of Left Kidney, run by Stony Brook University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit desired number of patients in reasonable time frame). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: number of days immediately after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.