Opioid Use DisorderEarly Phase 1NCT07211399
Transition From Acute to Chronic Opioid Use and Chronic Pain
A Early Phase 1 study testing Opioid-free anesthesia and Opioid-based anesthesia in people with Opioid Use Disorder, run by Jacques E. Chelly at 1 site in United States.
Trial summary
In the current opioid crisis, the use of opioids as the main pain management method is recognized as a consistent risk factor for chronic opioid use and the development of Opioid Use Disorder (OUD), as well as related complications like overdose fatalities among surgical patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Opioid-free anesthesia and Opioid-based anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 1 Dec 2030
- Phase
- Early Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old
- scheduled for an elective, unilateral Total Knee Arthroplasty (TKA)
- anticipated to stay in PACU after surgery
- receiving general anesthesia (i.e. fentanyl, etc.)
- receiving spinal regional anesthesia
Who cannot join
- <18 years of age
- sent to the ICU at any point during their hospital stay
- scheduled for a bilateral TKA
- received intraoperative opioids other than fentanyl
- received patient-controlled analgesia in PACU
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
About this study
Official title: The Role of Intraoperative Opioids in the Transition From Acute to Chronic Opioid Use and Chronic Pain
In the current opioid crisis, the use of opioids as the main pain management method is recognized as a consistent risk factor for chronic opioid use and the development of Opioid Use Disorder (OUD), as well as related complications like overdose fatalities among surgical patients. The most recent data suggests that 3.1%-10.5% of surgical patients are at risk of developing OUD. On average, there are over 40 million major surgeries that require post-op pain management, taking place in the United States each year. This puts over 1 million American surgical patients at risk for opioid dependency and misuse.
This is a prospective randomized controlled intervention study that will examine the physical and emotional outcomes of surgical patients who receive intraoperative Opioid-Free Anesthesia (OFA) supplemented with Non-Opioid Analgesia (NOAs), and how this relates to surgical patients who receive intraoperative Opioid-Based Anesthesia (OBA).
- Conditions
- Opioid Use Disorder
- Being tested
- Opioid-free anesthesia, Opioid-based anesthesia
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid-free anesthesiaDrug
Also called Dexmedetomidine & Ketamine Group
Each patient will be pre-oxygenated receive IV-acetaminophen (1 g), and IV-lidocaine (60 - 100 mg). and dexmedetomidine (12-20 mcg IV) and ketamine (25-50 mcg) prior to intubation. Induction of anesthesia will be achieved with IV-propofol (1 - 2 mg/kg; 150 - 200 mg). Patient air ways will be secured with an intratracheal tube or LMA. Anesthesia will be maintained by either propofol (100 - 150 mcg/kg/hour; TIVA), or sevoflurane (0.5-1 MAC). During surgery, dexmedetomidine and ketamine will be administered as needed. Anesthesia will be maintained by either propofol (100 - 150 mcg/kg/hour; TIVA), or sevoflurane (0.5-1 MAC).
Opioid-based anesthesiaDrug
Also called Fentanyl Group
Each patient will be pre-oxygenated receive IV-acetaminophen (1 g), and IV-lidocaine (60 - 100 mg). and fentanyl 50-100 mcg IV prior to intubation. Induction of anesthesia will be achieved with IV-propofol (1 - 2 mg/kg; 150 - 200 mg). Patient air ways will be secured with an intratracheal tube or LMA. Anesthesia will be maintained by either propofol (100 - 150 mcg/kg/hour; TIVA), or sevoflurane (0.5-1 MAC). During surgery, each patient in the opioid group will receive IV-fentanyl (50 - 100 mcg) as needed.
| Study group | Role | What they receive |
|---|---|---|
| Opioid-free anesthesia (OFA) Group | Experimental | Subjects enrolled in this arm will receive IV-acetaminophen, IV-lidocaine, dexmedetomidine, and ketamine prior to intubation. Receives: Drug: Opioid-free anesthesia |
| Opioid-based anesthesia (OBA) Group | Active comparator | Subjects enrolled in this arm will receive IV-acetaminophen, IV-lidocaine, and fentanyl prior to intubation. Receives: Drug: Opioid-based anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
PACU Opioid Medication Administered
Medications will be extracted from the electronic medical records. Opioid-based medications will be reported as mean(SD).
Measured: Postoperative Day 5
PACU Non-Opioid Medication Administered
Medications will be extracted from the electronic medical records.Non-opioid-based medications will be reported as mean(SD).
Measured: Postoperative Day 5
PACU NRS Pain Score at Rest
Numerical Rating Scale (NRS) Pain Scores will be self reported on a scale of 0-10, 0 being no pain at all, 10 being worst pain imaginable. Pain scores at rest will be averaged and reported as mean(SD).
Measured: Postoperative Day 5
PACU NRS Pain Score with Movement
Numerical Rating Scale (NRS) Pain Scores will be self reported on a scale of 0-10, 0 being no pain at all, 10 being worst pain imaginable. Pain scores with movement will be averaged and reported as mean(SD).
Measured: Postoperative Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (estimated)
Why it stopped: Study did not receive funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective RCT aiming to examine the effectiveness of OFA on the reduction of postoperative acute and chronic pain and opioid use among 700 adult TKA patients.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacques E. Chelly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jacques E. Chelly, University of Pittsburgh
- Investigators
- Jacques Chelly, MD, PhD, MBA, Principal investigator, University of Pittsburgh, UPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211399
- Sponsor's protocol ID
- STUDY25050099
- Status last verified
- Jun 2026
- First submitted
- 1 Oct 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified information collected throughout the study will be included in a study database. No patient identifiers will be included in the database and there will be a confidential (access limited to investigators only) code or link between the database and other information about the participant. De-identified data may be shared with additional internal or external data warehouses/investigators and the NIH. Data may be shared with authorized representatives of the study sponsor and federal regulatory agencies for purposes of monitoring the conduct of this study. If data is to be shared with other external organizations in the future, the IRB will be modified accordingly, and an appropriate Date Use Agreement will be secured.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Intraoperative Opioids in the Transition From Acute to Chronic Opioid Use and Chronic Pain
- ClinicalTrials.gov ID
- NCT07211399
- Acronym / sponsor ID
- STUDY25050099
- Conditions
- Opioid Use Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study did not receive funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jacques E. ChellyUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 8 Oct 2025 (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.
In the current opioid crisis, the use of opioids as the main pain management method is recognized as a consistent risk factor for chronic opioid use and the development of Opioid Use Disorder (OUD), as well as related complications like overdose fatalities among surgical patients. The most recent data suggests that 3.1%-10.5% of surgical patients are at risk of developing OUD. On average, there are over 40 million major surgeries that require post-op pain management, taking place in the United States each year. This puts over 1 million American surgical patients at risk for opioid dependency and misuse.
This is a prospective randomized controlled intervention study that will examine the physical and emotional outcomes of surgical patients who receive intraoperative Opioid-Free Anesthesia (OFA) supplemented with Non-Opioid Analgesia (NOAs), and how this relates to surgical patients who receive intraoperative Opioid-Based Anesthesia (OBA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective RCT aiming to examine the effectiveness of OFA on the reduction of postoperative acute and chronic pain and opioid use among 700 adult TKA patients.
| Arm | Type | Receives |
|---|---|---|
| Opioid-free anesthesia (OFA) Group | Experimental | Drug: Opioid-free anesthesiaSubjects enrolled in this arm will receive IV-acetaminophen, IV-lidocaine, dexmedetomidine, and ketamine prior to intubation. |
| Opioid-based anesthesia (OBA) Group | Active comparator | Drug: Opioid-based anesthesiaSubjects enrolled in this arm will receive IV-acetaminophen, IV-lidocaine, and fentanyl prior to intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years old
- scheduled for an elective, unilateral Total Knee Arthroplasty (TKA)
- anticipated to stay in PACU after surgery
- receiving general anesthesia (i.e. fentanyl, etc.)
- receiving spinal regional anesthesia
Key exclusion criteria (5 listed)
- <18 years of age
- sent to the ICU at any point during their hospital stay
- scheduled for a bilateral TKA
- received intraoperative opioids other than fentanyl
- received patient-controlled analgesia in PACU
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 |
|---|---|---|
| Opioid-free anesthesiaAlso: Dexmedetomidine & Ketamine GroupEach patient will be pre-oxygenated receive IV-acetaminophen (1 g), and IV-lidocaine (60 - 100 mg). and dexmedetomidine (12-20 mcg IV) and ketamine (25-50 mcg) prior to intubation. Induction of anesthesia will be achieved with IV-propofol (1 - 2 mg/kg; 150 - 200 mg). Patient air ways will be secured with an intratracheal tube or LMA. Anesthesia will be maintained by either propofol (100 - 150 mcg/kg/hour; TIVA), or sevoflurane (0.5-1 MAC). During surgery, dexmedetomidine and ketamine will be administered as needed. Anesthesia will be maintained by either propofol (100 - 150 mcg/kg/hour; TIVA), or sevoflurane (0.5-1 MAC). | Drug | Opioid-free anesthesia (OFA) Group |
| Opioid-based anesthesiaAlso: Fentanyl GroupEach patient will be pre-oxygenated receive IV-acetaminophen (1 g), and IV-lidocaine (60 - 100 mg). and fentanyl 50-100 mcg IV prior to intubation. Induction of anesthesia will be achieved with IV-propofol (1 - 2 mg/kg; 150 - 200 mg). Patient air ways will be secured with an intratracheal tube or LMA. Anesthesia will be maintained by either propofol (100 - 150 mcg/kg/hour; TIVA), or sevoflurane (0.5-1 MAC). During surgery, each patient in the opioid group will receive IV-fentanyl (50 - 100 mcg) as needed. | Drug | Opioid-based anesthesia (OBA) Group |
Primary outcome
PACU Opioid Medication Administered
Time frame: Postoperative Day 5
Medications will be extracted from the electronic medical records. Opioid-based medications will be reported as mean(SD).
PACU Non-Opioid Medication Administered
Time frame: Postoperative Day 5
Medications will be extracted from the electronic medical records.Non-opioid-based medications will be reported as mean(SD).
PACU NRS Pain Score at Rest
Time frame: Postoperative Day 5
Numerical Rating Scale (NRS) Pain Scores will be self reported on a scale of 0-10, 0 being no pain at all, 10 being worst pain imaginable. Pain scores at rest will be averaged and reported as mean(SD).
PACU NRS Pain Score with Movement
Time frame: Postoperative Day 5
Numerical Rating Scale (NRS) Pain Scores will be self reported on a scale of 0-10, 0 being no pain at all, 10 being worst pain imaginable. Pain scores with movement will be averaged and reported as mean(SD).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No. De-identified information collected throughout the study will be included in a study database. No patient identifiers will be included in the database and there will be a confidential (access limited to investigators only) code or link between the database and other information about the participant. De-identified data may be shared with additional internal or external data warehouses/investigators and the NIH. Data may be shared with authorized representatives of the study sponsor and federal regulatory agencies for purposes of monitoring the conduct of this study. If data is to be shared with other external organizations in the future, the IRB will be modified accordingly, and an appropriate Date Use Agreement will be secured.
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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.
Jacques Chelly, MD, PhD, MBA principal investigator
University of Pittsburgh, UPMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Opioid-free anesthesia and Opioid-based anesthesia in people with Opioid Use Disorder, run by Jacques E. Chelly 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 30 Jun 2026. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
PACU Opioid Medication Administered (time frame: Postoperative Day 5). The study lists 4 primary outcomes in all. 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 30 Jun 2026.