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Terminated early due to funding, lack of participants
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In this case series study, the investigators are testing the hypothesis that sublingual sufentanil (Dsuvia) will improve postoperative pain management in the Post Anesthesia Care Unit (PACU) in ambulatory surgery patients taking Suboxone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Subjects will receive dose of Dsuvia 30mcg SL (1st dose) after induction but before first incision. Post-operatively, if subject rates pain higher than 4 out of 10, subject will receive a second dose of Dsuvia 30mcg SL (sublingual). If 30 minutes after second dose, subject rates pain higher than 4 out of 10, subject will receive ibuprofen 800mg IV. If 60 minutes after second dose, subject rates pain higher than 7 out of 10, subject will receive hydromorphone 0.4 mg IV. |
|
| Control | No Intervention | Subjects will be receive routine standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dsuvia | Drug | Subject will receive up to 2 doses of Dsuvia. The first dose will be intra-op and the second dose will be post-op (if needed) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Equivalence | Evaluate the total amount of morphine equivalence (MME) in the perioperative period (defined as combined total opioid used intra-op and in the PACU). | During day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Fit to Discharge From the PACU (Post-Anesthesia Care Unit) | How much time did subject take to become considered 'fit to discharge?' | During stay in PACU, up until discharge from PACU |
| Need for Additional Opioids Following Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naum Shaparin, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28511196 | Background | Anderson TA, Quaye ANA, Ward EN, Wilens TE, Hilliard PE, Brummett CM. To Stop or Not, That Is the Question: Acute Pain Management for the Patient on Chronic Buprenorphine. Anesthesiology. 2017 Jun;126(6):1180-1186. doi: 10.1097/ALN.0000000000001633. | |
| 21054613 | Background | Degenhardt L, Bucello C, Mathers B, Briegleb C, Ali H, Hickman M, McLaren J. Mortality among regular or dependent users of heroin and other opioids: a systematic review and meta-analysis of cohort studies. Addiction. 2011 Jan;106(1):32-51. doi: 10.1111/j.1360-0443.2010.03140.x. Epub 2010 Nov 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Subjects will receive dose of Dsuvia 30mcg SL (1st dose) after induction but before first incision. Post-operatively, if subject rates pain higher than 4 out of 10, subject will receive a second dose of Dsuvia 30mcg SL (sublingual). If 30 minutes after second dose, subject rates pain higher than 4 out of 10, subject will receive ibuprofen 800mg IV. If 60 minutes after second dose, subject rates pain higher than 7 out of 10, subject will receive hydromorphone 0.4 mg IV. Dsuvia: Subject will receive up to 2 doses of Dsuvia. The first dose will be intra-op and the second dose will be post-op (if needed) |
| FG001 | Control | Subjects will be receive routine standard of care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No participants were enrolled into the Control (Standard of Care) arm prior to study termination. As such, zero participants were identified in the corresponding categories for the Control (Standard of Care) arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Subjects will receive dose of Dsuvia 30mcg SL (1st dose) after induction but before first incision. Post-operatively, if subject rates pain higher than 4 out of 10, subject will receive a second dose of Dsuvia 30mcg SL (sublingual). If 30 minutes after second dose, subject rates pain higher than 4 out of 10, subject will receive ibuprofen 800mg IV. If 60 minutes after second dose, subject rates pain higher than 7 out of 10, subject will receive hydromorphone 0.4 mg IV. Dsuvia: Subject will receive up to 2 doses of Dsuvia. The first dose will be intra-op and the second dose will be post-op (if needed) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Morphine Equivalence | Evaluate the total amount of morphine equivalence (MME) in the perioperative period (defined as combined total opioid used intra-op and in the PACU). | Data was not collected/aggregated. As such there was no data analysis for this terminated study. | Posted | During day of surgery |
|
Intraoperative period through 24 hours following discharge from PACU - an average of 24-48 hours.
No participants were enrolled into the Control (Standard of Care) arm prior to study termination. As such, zero participants were identified as having been 'at risk' in the denominator for the Control (Standard of Care) arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Subjects will receive dose of Dsuvia 30mcg SL (1st dose) after induction but before first incision. Post-operatively, if subject rates pain higher than 4 out of 10, subject will receive a second dose of Dsuvia 30mcg SL (sublingual). If 30 minutes after second dose, subject rates pain higher than 4 out of 10, subject will receive ibuprofen 800mg IV. If 60 minutes after second dose, subject rates pain higher than 7 out of 10, subject will receive hydromorphone 0.4 mg IV. Dsuvia: Subject will receive up to 2 doses of Dsuvia. The first dose will be intra-op and the second dose will be post-op (if needed) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Naum Shaparin | Montefiore Medical Center | 718-920-4316 | nshapari@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 8, 2021 | Jun 26, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000655104 | Dsuvia |
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A measure of how any additional opioids subjects were administered
| PACU stay to 24 hours post hospital discharge |
| Time to Take the First Additional Opioid | Average time for administration of first additional opioid. | 24 hours post hospital discharge |
| Adverse Events in the PACU | Make note of nausea, vomiting, itching, hypotension, dizziness that occur while in PACU | During PACU stay, up until discharge from PACU |
| Adverse Events Post Discharge From PACU | Make note of nausea, vomiting, itching, hypotension, dizziness that occur within 24 hours after being discharged from PACU | 24 hours |
| 15781180 | Background | Johnson RE, Fudala PJ, Payne R. Buprenorphine: considerations for pain management. J Pain Symptom Manage. 2005 Mar;29(3):297-326. doi: 10.1016/j.jpainsymman.2004.07.005. |
| 16418412 | Background | Alford DP, Compton P, Samet JH. Acute pain management for patients receiving maintenance methadone or buprenorphine therapy. Ann Intern Med. 2006 Jan 17;144(2):127-34. doi: 10.7326/0003-4819-144-2-200601170-00010. |
| 23702611 | Background | Hansen HB, Siegel CE, Case BG, Bertollo DN, DiRocco D, Galanter M. Variation in use of buprenorphine and methadone treatment by racial, ethnic, and income characteristics of residential social areas in New York City. J Behav Health Serv Res. 2013 Jul;40(3):367-77. doi: 10.1007/s11414-013-9341-3. |
| 15957687 | Background | Roberts DM, Meyer-Witting M. High-dose buprenorphine: perioperative precautions and management strategies. Anaesth Intensive Care. 2005 Feb;33(1):17-25. doi: 10.1177/0310057X0503300104. |
| 378645 | Background | Heel RC, Brogden RN, Speight TM, Avery GS. Buprenorphine: a review of its pharmacological properties and therapeutic efficacy. Drugs. 1979 Feb;17(2):81-110. doi: 10.2165/00003495-197917020-00001. |
| 9052292 | Background | Claxton AR, McGuire G, Chung F, Cruise C. Evaluation of morphine versus fentanyl for postoperative analgesia after ambulatory surgical procedures. Anesth Analg. 1997 Mar;84(3):509-14. doi: 10.1097/00000539-199703000-00008. |
| 14622770 | Background | Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80. doi: 10.1054/jpai.2002.123652. No abstract available. |
| 21841049 | Background | Felden L, Walter C, Harder S, Treede RD, Kayser H, Drover D, Geisslinger G, Lotsch J. Comparative clinical effects of hydromorphone and morphine: a meta-analysis. Br J Anaesth. 2011 Sep;107(3):319-28. doi: 10.1093/bja/aer232. Epub 2011 Aug 5. |
| 27781372 | Background | Minkowitz HS, Leiman D, Melson T, Singla N, DiDonato KP, Palmer PP. Sufentanil Sublingual Tablet 30 mcg for the Management of Pain Following Abdominal Surgery: A Randomized, Placebo-Controlled, Phase-3 Study. Pain Pract. 2017 Sep;17(7):848-858. doi: 10.1111/papr.12531. Epub 2017 Feb 10. |
| 26079801 | Background | Jove M, Griffin DW, Minkowitz HS, Ben-David B, Evashenk MA, Palmer PP. Sufentanil Sublingual Tablet System for the Management of Postoperative Pain after Knee or Hip Arthroplasty: A Randomized, Placebo-controlled Study. Anesthesiology. 2015 Aug;123(2):434-43. doi: 10.1097/ALN.0000000000000746. |
| 25318408 | Background | Ringold FG, Minkowitz HS, Gan TJ, Aqua KA, Chiang YK, Evashenk MA, Palmer PP. Sufentanil sublingual tablet system for the management of postoperative pain following open abdominal surgery: a randomized, placebo-controlled study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):22-30. doi: 10.1097/AAP.0000000000000152. |
| Background | W.M. Tvetenstrand CD, Reduced Opioid Use and Reduced Time in the Postanesthesia Care Unit Following Preoperative Administration of Sublingual Sufentanil in an Ambulatory Surgery Setting., J Clin Anesth Pain Manag. 4 2. |
| BG001 | Control | Subjects will be receive routine standard of care. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Control | Subjects will be receive routine standard of care. |
|
| Secondary | Time to Fit to Discharge From the PACU (Post-Anesthesia Care Unit) | How much time did subject take to become considered 'fit to discharge?' | Data was not collected/aggregated. As such there was no data analysis for this terminated study. | Posted | During stay in PACU, up until discharge from PACU |
|
|
| Secondary | Need for Additional Opioids Following Surgery | A measure of how any additional opioids subjects were administered | Data was not collected/aggregated. As such there was no data analysis for this terminated study. | Posted | PACU stay to 24 hours post hospital discharge |
|
|
| Secondary | Time to Take the First Additional Opioid | Average time for administration of first additional opioid. | Data was not collected/aggregated. As such there was no data analysis for this terminated study. | Posted | 24 hours post hospital discharge |
|
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| Secondary | Adverse Events in the PACU | Make note of nausea, vomiting, itching, hypotension, dizziness that occur while in PACU | Data was not collected/aggregated. As such there was no data analysis for this terminated study. | Posted | During PACU stay, up until discharge from PACU |
|
|
| Secondary | Adverse Events Post Discharge From PACU | Make note of nausea, vomiting, itching, hypotension, dizziness that occur within 24 hours after being discharged from PACU | Data was not collected/aggregated. As such there was no data analysis for this terminated study. | Posted | 24 hours |
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| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Control | Subjects will be receive routine standard of care. | 0 | 0 | 0 | 0 | 0 | 0 |
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