Opioid UsePhase 4NCT04625283
The Impact of Perioperative Ketamine Infusion on Surgical Recovery
A Phase 4 study testing Ketamine in people with Opioid Use and Enhanced Recovery After Surgery, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
In order to effectively treat surgical pain with the least amount of opioids required, a multi-modal approach must include medications with different mechanisms of actions at alternative receptors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Enhanced Recovery After Surgery, Anesthesia
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,570 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2021to 1 Feb 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old or greater
- presenting at VUMC for abdominal surgery on the colorectal, ventral hernia or surgical oncology services on a weekday.
Who cannot join
- allergy or contraindication to ketamine
- unable or refuse to receive a neuraxial or regional nerve block
- patient refusal
- direct transfer from operating room to intensive care unit with endotracheal tube placed
- treating team elects to exclude the patient prior to study drug administration
- abortion of planned surgical procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: The Effect and Contribution of a Perioperative Ketamine Infusion in an Established Enhanced Recovery Pathway
In order to effectively treat surgical pain with the least amount of opioids required, a multi-modal approach must include medications with different mechanisms of actions at alternative receptors. In light of the opioid epidemic, medical providers at Vanderbilt University Medical Center (VUMC) are strategically combining these medications in a bundled pain-regimen after surgery. These regimens have been shown to decrease opioid consumption, improve surgical outcomes, and reduce hospital stays, thus coining the term 'enhanced recovery pathway'. The combination of these medications has an indisputable synergistic effect. However, it is unknown how each medication contributes individually to the overall efficacy of the pathway. This study will examine the effects of ketamine, within the constructs of a multimodal pain regimen, on a) length of stay, b) opioid consumption, and c) surgical outcomes after major abdominal surgery.
Read the detailed description
Opioids are powerful analgesic medications that can reduce pain through action at the mu receptor. Unfortunately, activation of the mu receptor also results in undesirable side effects, such as respiratory depression, sedation, bowel ileus, nausea, itching, and tolerance. Therefore, in order to effectively treat pain with the least amount of opioids required, a multi-modal approach must include medications with different mechanisms of actions at alternative receptors. Some examples of non-narcotic pain medications include acetaminophen (Tylenol), anti-inflammatories (NSAIDS), muscle relaxants, local anesthetics, gabapentinoids (Lyrica), and ketamine, to name a few. In light of the opioid epidemic, medical providers at Vanderbilt University Medical Center (VUMC) are strategically combining these medications in a bundled pain-regimen after surgery. These regimens have been shown to decrease opioid consumption, improve surgical outcomes, and reduce hospital stays, thus coining the term 'enhanced recovery pathway' or enhanced recovery after surgery (ERAS). The combination of these medications has an indisputable synergistic effect. However, it is unknown how each medication contributes individually to the overall efficacy of the pathway. Ultimately, the investigators aim to perform a series of randomized controlled trials in which we isolate each component of the pathway to investigate its effects on length of stay, total opioid consumption, and surgical outcomes. The investigators will begin with studying ketamine.
- Being tested
- Ketamine, Placebo
- Keywords
- ERAS, Enhanced Recovery After Surgery, Ketamine, Opioid, Learning Healthcare System
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
Participants in the ketamine arm will receive intraoperative and postoperative ketamine.
PlaceboDrug
Also called Saline
Participants in the placebo arm will receive intraoperative and postoperative saline.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | Participants in this arm will receive intraoperative ketamine bolus (0.5mg/kg) followed by continuous infusion 5 mcg/kg/min and also will receive postoperative ketamine infusion (2.5 mcg/kg/min, up to 100kg max) for 48 hours. Receives: Drug: Ketamine |
| Saline | Placebo comparator | Participants in this arm will receive an equivalent volume of intraoperative saline bolus followed by continuous saline infusion and also will receive postoperative saline infusion for 48 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
The participants length of stay, from anesthesia beginning to discharge, measured in days
Measured: From surgery start until discharge, typically 3-5 days
Secondary outcomes (5)
Total Consumption of Inpatient Opioids
Inpatient opioid consumption measured in morphine milligram equivalents
Measured: From hospital admission until discharge, typically 3-5 days
Number of Participants With Ileus
Number of participants reporting ileus requiring gastric decompression as defined by orogastric or nasogastric tube placement in the postoperative period.
Measured: From hospital admission until discharge, typically 3-5 days
Number of Participants Who Encounter Rapid Response Team Activation
Number of participants who encounter rapid response team activation within 72 hours post-operation. This is as a binary outcome
Measured: From hospital admission until discharge, typically 3-5 days
Number of Participants Who Experienced ICU Transfer
Number of participants who experienced transfer to ICU. This is as a binary outcome
Measured: From hospital admission until discharge, typically 3-5 days
Number of Participants Who Experienced Adverse Side Effects
Total number of side effects (hallucination, sedation, lightheadedness, patient request) as adverse reactions requiring early cessation.
Measured: From hospital admission until discharge, typically 3-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start12 Apr 2021
- Primary completion26 Jan 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be performed as a pragmatic controlled clinical trial with parallel group assignment. Randomization will be in a cluster format.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,570 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Britany Lynn Raymond, MD, Vanderbilt University Medical Center
- Investigators
- Britany L Raymond, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625283
- Sponsor's protocol ID
- 200210
- Status last verified
- Jan 2025
- First submitted
- 6 Nov 2020
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share individual participant data.
Publications
Boenigk K, Echevarria GC, Nisimov E, von Bergen Granell AE, Cuff GE, Wang J, Atchabahian A. Low-dose ketamine infusion reduces postoperative hydromorphone requirements in opioid-tolerant patients following spinal fusion: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jan;36(1):8-15. doi: 10.1097/EJA.0000000000000877.
PubMed 30113350Kaur S, Saroa R, Aggarwal S. Effect of intraoperative infusion of low-dose ketamine on management of postoperative analgesia. J Nat Sci Biol Med. 2015 Jul-Dec;6(2):378-82. doi: 10.4103/0976-9668.160012.
PubMed 26283834Kim SH, Kim SI, Ok SY, Park SY, Kim MG, Lee SJ, Noh JI, Chun HR, Suh H. Opioid sparing effect of low dose ketamine in patients with intravenous patient-controlled analgesia using fentanyl after lumbar spinal fusion surgery. Korean J Anesthesiol. 2013 Jun;64(6):524-8. doi: 10.4097/kjae.2013.64.6.524. Epub 2013 Jun 24.
PubMed 23814653Suppa E, Valente A, Catarci S, Zanfini BA, Draisci G. A study of low-dose S-ketamine infusion as "preventive" pain treatment for cesarean section with spinal anesthesia: benefits and side effects. Minerva Anestesiol. 2012 Jul;78(7):774-81. Epub 2012 Feb 29.
PubMed 22374377Remerand F, Le Tendre C, Baud A, Couvret C, Pourrat X, Favard L, Laffon M, Fusciardi J. The early and delayed analgesic effects of ketamine after total hip arthroplasty: a prospective, randomized, controlled, double-blind study. Anesth Analg. 2009 Dec;109(6):1963-71. doi: 10.1213/ANE.0b013e3181bdc8a0.
PubMed 19923527Pergolizzi JV Jr, Rosenblatt M, LeQuang JA. Three Years Down the Road: The Aftermath of the CDC Guideline for Prescribing Opioids for Chronic Pain. Adv Ther. 2019 Jun;36(6):1235-1240. doi: 10.1007/s12325-019-00954-1. Epub 2019 Apr 23.
PubMed 31016474Kent ML, Hurley RW, Oderda GM, Gordon DB, Sun E, Mythen M, Miller TE, Shaw AD, Gan TJ, Thacker JKM, McEvoy MD; POQI-4 Working Group. American Society for Enhanced Recovery and Perioperative Quality Initiative-4 Joint Consensus Statement on Persistent Postoperative Opioid Use: Definition, Incidence, Risk Factors, and Health Care System Initiatives. Anesth Analg. 2019 Aug;129(2):543-552. doi: 10.1213/ANE.0000000000003941.
PubMed 30897590Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
PubMed 28403427Kurokawa Y, Kurokawa T, Tanimoto T. Opioid Prescription After Surgery. JAMA Surg. 2019 Jul 1;154(7):675. doi: 10.1001/jamasurg.2019.0573. No abstract available.
PubMed 31017640Mercadante S. Opioid Analgesics Adverse Effects: The Other Side of the Coin. Curr Pharm Des. 2019;25(30):3197-3202. doi: 10.2174/1381612825666190717152226.
PubMed 31333113McEvoy MD, Wanderer JP, King AB, Geiger TM, Tiwari V, Terekhov M, Ehrenfeld JM, Furman WR, Lee LA, Sandberg WS. A perioperative consult service results in reduction in cost and length of stay for colorectal surgical patients: evidence from a healthcare redesign project. Perioper Med (Lond). 2016 Feb 5;5:3. doi: 10.1186/s13741-016-0028-1. eCollection 2016.
PubMed 26855773Hawkins AT, Geiger TM, King AB, Wanderer JP, Tiwari V, Muldoon RL, Ford MM, Dmochowski RR, Sandberg WS, Martin B, Hopkins MB, McEvoy MD. An enhanced recovery program in colorectal surgery is associated with decreased organ level rates of complications: a difference-in-differences analysis. Surg Endosc. 2019 Jul;33(7):2222-2230. doi: 10.1007/s00464-018-6508-2. Epub 2018 Oct 17.
PubMed 30334161King AB, Spann MD, Jablonski P, Wanderer JP, Sandberg WS, McEvoy MD. An enhanced recovery program for bariatric surgical patients significantly reduces perioperative opioid consumption and postoperative nausea. Surg Obes Relat Dis. 2018 Jun;14(6):849-856. doi: 10.1016/j.soard.2018.02.010. Epub 2018 Feb 13.
PubMed 29555468Li Z, Zhao Q, Bai B, Ji G, Liu Y. Enhanced Recovery After Surgery Programs for Laparoscopic Abdominal Surgery: A Systematic Review and Meta-analysis. World J Surg. 2018 Nov;42(11):3463-3473. doi: 10.1007/s00268-018-4656-0.
PubMed 29750324Greco M, Capretti G, Beretta L, Gemma M, Pecorelli N, Braga M. Enhanced recovery program in colorectal surgery: a meta-analysis of randomized controlled trials. World J Surg. 2014 Jun;38(6):1531-41. doi: 10.1007/s00268-013-2416-8.
PubMed 24368573
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Contribution of a Perioperative Ketamine Infusion in an Established Enhanced Recovery Pathway
- ClinicalTrials.gov ID
- NCT04625283
- Acronym / sponsor ID
- 200210
- Keywords
- ERAS, Enhanced Recovery After Surgery, Ketamine, Opioid, Learning Healthcare System
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,570 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Posted 4 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In order to effectively treat surgical pain with the least amount of opioids required, a multi-modal approach must include medications with different mechanisms of actions at alternative receptors. In light of the opioid epidemic, medical providers at Vanderbilt University Medical Center (VUMC) are strategically combining these medications in a bundled pain-regimen after surgery. These regimens have been shown to decrease opioid consumption, improve surgical outcomes, and reduce hospital stays, thus coining the term 'enhanced recovery pathway'. The combination of these medications has an indisputable synergistic effect. However, it is unknown how each medication contributes individually to the overall efficacy of the pathway. This study will examine the effects of ketamine, within the constructs of a multimodal pain regimen, on a) length of stay, b) opioid consumption, and c) surgical outcomes after major abdominal surgery.
Detailed description
Opioids are powerful analgesic medications that can reduce pain through action at the mu receptor. Unfortunately, activation of the mu receptor also results in undesirable side effects, such as respiratory depression, sedation, bowel ileus, nausea, itching, and tolerance. Therefore, in order to effectively treat pain with the least amount of opioids required, a multi-modal approach must include medications with different mechanisms of actions at alternative receptors. Some examples of non-narcotic pain medications include acetaminophen (Tylenol), anti-inflammatories (NSAIDS), muscle relaxants, local anesthetics, gabapentinoids (Lyrica), and ketamine, to name a few. In light of the opioid epidemic, medical providers at Vanderbilt University Medical Center (VUMC) are strategically combining these medications in a bundled pain-regimen after surgery. These regimens have been shown to decrease opioid consumption, improve surgical outcomes, and reduce hospital stays, thus coining the term 'enhanced recovery pathway' or enhanced recovery after surgery (ERAS). The combination of these medications has an indisputable synergistic effect. However, it is unknown how each medication contributes individually to the overall efficacy of the pathway. Ultimately, the investigators aim to perform a series of randomized controlled trials in which we isolate each component of the pathway to investigate its effects on length of stay, total opioid consumption, and surgical outcomes. The investigators will begin with studying ketamine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be performed as a pragmatic controlled clinical trial with parallel group assignment. Randomization will be in a cluster format.
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: KetamineParticipants in this arm will receive intraoperative ketamine bolus (0.5mg/kg) followed by continuous infusion 5 mcg/kg/min and also will receive postoperative ketamine infusion (2.5 mcg/kg/min, up to 100kg max) for 48 hours. |
| Saline | Placebo comparator | Drug: PlaceboParticipants in this arm will receive an equivalent volume of intraoperative saline bolus followed by continuous saline infusion and also will receive postoperative saline infusion for 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years old or greater
- presenting at VUMC for abdominal surgery on the colorectal, ventral hernia or surgical oncology services on a weekday.
Key exclusion criteria (6 listed)
- allergy or contraindication to ketamine
- unable or refuse to receive a neuraxial or regional nerve block
- patient refusal
- direct transfer from operating room to intensive care unit with endotracheal tube placed
- treating team elects to exclude the patient prior to study drug administration
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 |
|---|---|---|
| KetamineAlso: KetalarParticipants in the ketamine arm will receive intraoperative and postoperative ketamine. | Drug | Ketamine |
| PlaceboAlso: SalineParticipants in the placebo arm will receive intraoperative and postoperative saline. | Drug | Saline |
Primary outcome
Length of Stay
Time frame: From surgery start until discharge, typically 3-5 days
The participants length of stay, from anesthesia beginning to discharge, measured in days
5 secondary outcomes
Total Consumption of Inpatient Opioids
Time frame: From hospital admission until discharge, typically 3-5 days
Number of Participants With Ileus
Time frame: From hospital admission until discharge, typically 3-5 days
Number of Participants Who Encounter Rapid Response Team Activation
Time frame: From hospital admission until discharge, typically 3-5 days
Number of Participants Who Experienced ICU Transfer
Time frame: From hospital admission until discharge, typically 3-5 days
Number of Participants Who Experienced Adverse Side Effects
Time frame: From hospital admission until discharge, typically 3-5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30113350Boenigk K, Echevarria GC, Nisimov E, von Bergen Granell AE, Cuff GE, Wang J, Atchabahian A. Low-dose ketamine infusion reduces postoperative hydromorphone requirements in opioid-tolerant patients following spinal fusion: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jan;36(1):8-15. doi: 10.1097/EJA.0000000000000877.
- Background: PubMed 26283834Kaur S, Saroa R, Aggarwal S. Effect of intraoperative infusion of low-dose ketamine on management of postoperative analgesia. J Nat Sci Biol Med. 2015 Jul-Dec;6(2):378-82. doi: 10.4103/0976-9668.160012.
- Background: PubMed 23814653Kim SH, Kim SI, Ok SY, Park SY, Kim MG, Lee SJ, Noh JI, Chun HR, Suh H. Opioid sparing effect of low dose ketamine in patients with intravenous patient-controlled analgesia using fentanyl after lumbar spinal fusion surgery. Korean J Anesthesiol. 2013 Jun;64(6):524-8. doi: 10.4097/kjae.2013.64.6.524. Epub 2013 Jun 24.
- Background: PubMed 22374377Suppa E, Valente A, Catarci S, Zanfini BA, Draisci G. A study of low-dose S-ketamine infusion as "preventive" pain treatment for cesarean section with spinal anesthesia: benefits and side effects. Minerva Anestesiol. 2012 Jul;78(7):774-81. Epub 2012 Feb 29.
- Background: PubMed 19923527Remerand F, Le Tendre C, Baud A, Couvret C, Pourrat X, Favard L, Laffon M, Fusciardi J. The early and delayed analgesic effects of ketamine after total hip arthroplasty: a prospective, randomized, controlled, double-blind study. Anesth Analg. 2009 Dec;109(6):1963-71. doi: 10.1213/ANE.0b013e3181bdc8a0.
- Background: PubMed 31016474Pergolizzi JV Jr, Rosenblatt M, LeQuang JA. Three Years Down the Road: The Aftermath of the CDC Guideline for Prescribing Opioids for Chronic Pain. Adv Ther. 2019 Jun;36(6):1235-1240. doi: 10.1007/s12325-019-00954-1. Epub 2019 Apr 23.
- Background: PubMed 30897590Kent ML, Hurley RW, Oderda GM, Gordon DB, Sun E, Mythen M, Miller TE, Shaw AD, Gan TJ, Thacker JKM, McEvoy MD; POQI-4 Working Group. American Society for Enhanced Recovery and Perioperative Quality Initiative-4 Joint Consensus Statement on Persistent Postoperative Opioid Use: Definition, Incidence, Risk Factors, and Health Care System Initiatives. Anesth Analg. 2019 Aug;129(2):543-552. doi: 10.1213/ANE.0000000000003941.
- Background: PubMed 28403427Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
- Background: PubMed 31017640Kurokawa Y, Kurokawa T, Tanimoto T. Opioid Prescription After Surgery. JAMA Surg. 2019 Jul 1;154(7):675. doi: 10.1001/jamasurg.2019.0573. No abstract available.
- Background: PubMed 31333113Mercadante S. Opioid Analgesics Adverse Effects: The Other Side of the Coin. Curr Pharm Des. 2019;25(30):3197-3202. doi: 10.2174/1381612825666190717152226.
- Background: PubMed 26855773McEvoy MD, Wanderer JP, King AB, Geiger TM, Tiwari V, Terekhov M, Ehrenfeld JM, Furman WR, Lee LA, Sandberg WS. A perioperative consult service results in reduction in cost and length of stay for colorectal surgical patients: evidence from a healthcare redesign project. Perioper Med (Lond). 2016 Feb 5;5:3. doi: 10.1186/s13741-016-0028-1. eCollection 2016.
- Background: PubMed 30334161Hawkins AT, Geiger TM, King AB, Wanderer JP, Tiwari V, Muldoon RL, Ford MM, Dmochowski RR, Sandberg WS, Martin B, Hopkins MB, McEvoy MD. An enhanced recovery program in colorectal surgery is associated with decreased organ level rates of complications: a difference-in-differences analysis. Surg Endosc. 2019 Jul;33(7):2222-2230. doi: 10.1007/s00464-018-6508-2. Epub 2018 Oct 17.
- Individual participant dataSharing planned: No. The investigators do not plan to share individual participant data.
Related trials for Opioid Use
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
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.
Britany L Raymond, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine in people with Opioid Use and Enhanced Recovery After Surgery, run by Vanderbilt University Medical Center at 1 site in United States.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Stay (time frame: From surgery start until discharge, typically 3-5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04625283, which also lists 25 linked publications.
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 4 Feb 2025.