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| ID | Type | Description | Link |
|---|---|---|---|
| U54GM115516-06 | U.S. NIH Grant/Contract | View source |
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This study was halted prior to accumulating the full number of participants due to difficulty in recruiting study subjects.
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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There is limited guidance on the optimal management of buprenorphine perioperatively and both buprenorphine discontinuation and continuation are acceptable standards of care. Buprenorphine continuation at low analgesic dosing is also accepted, however is not provided as a potential treatment strategy by the Substance Abuse and Mental Health Services Administration (SAMHSA). There is the risk of inadequate pain control necessitating opioid escalation when buprenorphine is continued. Preliminary clinical observations support buprenorphine continuation at low analgesic doses (8mg) as it adequately facilitates postoperative pain management without interrupting opioid use disorder (OUD) treatment, however to date, no prospective trial has investigated this treatment strategy in comparison to full dose buprenorphine continuation. Since optimal perioperative dosing strategies remain unknown, the purpose of this study is to investigate if buprenorphine continuation at analgesic dosing is superior to full dose buprenorphine continuation in individuals presenting for elective surgery.
The purpose of this study is to investigate whether buprenorphine continuation at analgesic dosing is superior to full dose buprenorphine continuation in individuals presenting for elective surgery. Adults scheduled for elective surgery who are taking ≥12mg buprenorphine for OUD treatment will be eligible for this study. Enrolled participants will be randomized to receive either a reduced analgesic dose of buprenorphine (8mg) or to continue buprenorphine on the day of surgery without dose reduction. The primary outcome of interest is postoperative pain scores. The secondary outcomes of interest are opioid consumption, opioid dispensing up to 30 days following the surgical procedure and OUD related symptoms, including opioid withdrawal, cravings and relapse. The investigators hypothesis is that there will be a clinically significant increase in pain scores when buprenorphine is continued in full compared to when it is continued at a lower analgesic dose. Clinical significance will be defined as a difference in composite pain scores of greater than 20% between groups. The investigators also hypothesize that opioid consumption and opioid dispensing will be greater with full dose buprenorphine continuation compared to low-dose continuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buprenorphine Dose Reduction | Other | Patients instructed to reduce buprenorphine to 8mg prior to surgery |
|
| Buprenorphine Full Dose Continuation | Other | Patients instructed to continue taking the full prescribed dose of buprenorphine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine | Drug | Patients randomized to this group will reduce their buprenorphine dose prior to surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain Scores: 24 Hours After Surgery | Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain) | 24 hours after surgery |
| Post-operative Pain Scores: 48 Hours After Surgery | Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain) | 48 hours after surgery |
| Post-operative Pain Scores: 72 Hours After Surgery | Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain) | 72 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | All opioids consumed through 72 hours after surgery combined into mean morphine equivalents | 3 days post-op |
| Opioid Dispensing | Prescriptions filled for the patient in the Prescription Awareness Tool |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aurora Quaye, MD | Maine Medical Center; Spectrum Healthcare Partners | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maine Medical Center | Portland | Maine | 04102 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Buprenorphine Dose Reduction | Patients instructed to reduce buprenorphine to 8mg prior to surgery Buprenorphine: Patients randomized to this group will reduce their buprenorphine dose prior to surgery. |
| FG001 | Buprenorphine Full Dose Continuation | Patients instructed to continue taking the full prescribed dose of buprenorphine. Buprenorphine: Patients randomized to this group will continue their buprenorphine at the full prescribed dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Buprenorphine Dose Reduction | Patients instructed to reduce buprenorphine to 8mg prior to surgery Buprenorphine: Patients randomized to this group will reduce their buprenorphine dose prior to surgery. |
| BG001 | Buprenorphine Full Dose Continuation |
| 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 | Post-operative Pain Scores: 24 Hours After Surgery | Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain) | Posted | Mean | Standard Deviation | score on a scale (NRS pain scale) | 24 hours after surgery |
|
30 days
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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 | Buprenorphine Dose Reduction | Patients instructed to reduce buprenorphine to 8mg prior to surgery Buprenorphine: Patients randomized to this group will reduce their buprenorphine dose prior to surgery. |
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Early termination due to low enrollment; limited data analysis performed because of the small number of subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lead Research Coordinator | MaineHealth, Department of Anethesiology | 207-662-2862 | janelle.richard@mainehealth.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 | May 12, 2022 | Sep 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Buprenorphine | Drug | Patients randomized to this group will continue their buprenorphine at the full prescribed dose. |
|
| 30 days following surgery |
| Opioid Withdrawal | Withdrawal symptoms as measured by the Clinical Opioid Withdrawal Scale (COWS, scores can range from 0-48 [5-12 mild; 13-24, moderate; 25-36, moderately severe; >36, severe withdrawal)](streamdown:incomplete-link) | 1-3 hours prior to surgery |
| Opioid Cravings | Measured by the Opioid Craving Scale (OCS); scale ranges from 0-30 with higher scores indicating higher levels of cravings | 1-3 hours prior to surgery |
| Opioid Cravings | Measured by the Opioid Craving Scale (OCS); scale ranges from 0-30 with higher scores indicating higher levels of cravings | 30 days following surgery |
| Opioid Misuse | Measured by the Current Opioid Misuse Measure ((COMM); scores can range from 0-68, scores of 9 or lower indicates a low risk of opioid misuse or abuse, scores higher than 9 indicate a high risk) | 1-3 hours prior to surgery |
| Opioid Misuse | Measured by the Current Opioid Misuse Measure ((COMM); scores can range from 0-68, scores of 9 or lower indicates a low risk of opioid misuse or abuse, scores higher than 9 indicate a high risk) | 30 days following surgery |
| Opioid Relapse | Patient reported use of non-prescribed opioids | 30 days following surgery |
Patients instructed to continue taking the full prescribed dose of buprenorphine. Buprenorphine: Patients randomized to this group will continue their buprenorphine at the full prescribed dose. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Current buprenorphine dose | Median | Full Range | mg |
|
|
|
| Primary | Post-operative Pain Scores: 48 Hours After Surgery | Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain) | Posted | Mean | Standard Deviation | score on a scale (NRS) | 48 hours after surgery |
|
|
|
| Primary | Post-operative Pain Scores: 72 Hours After Surgery | Highest, average, and lowest pain scores will be evaluated using the Numerical Rating Scale of 0 (no pain) -10 (worst pain) | Posted | Mean | Standard Deviation | score on a scale (NRS) | 72 hours after surgery |
|
|
|
| Secondary | Opioid Consumption | All opioids consumed through 72 hours after surgery combined into mean morphine equivalents | Posted | Mean | Full Range | morphine milligram equivalents (MME) | 3 days post-op |
|
|
|
| Secondary | Opioid Dispensing | Prescriptions filled for the patient in the Prescription Awareness Tool | Posted | Median | Inter-Quartile Range | morphine milligram equivalents | 30 days following surgery |
|
|
|
| Secondary | Opioid Withdrawal | Withdrawal symptoms as measured by the Clinical Opioid Withdrawal Scale (COWS, scores can range from 0-48 [5-12 mild; 13-24, moderate; 25-36, moderately severe; >36, severe withdrawal)](streamdown:incomplete-link) | Posted | Count of Participants | Participants | 1-3 hours prior to surgery |
|
|
|
| Secondary | Opioid Cravings | Measured by the Opioid Craving Scale (OCS); scale ranges from 0-30 with higher scores indicating higher levels of cravings | Posted | Mean | Full Range | score on a scale | 1-3 hours prior to surgery |
|
|
|
| Secondary | Opioid Cravings | Measured by the Opioid Craving Scale (OCS); scale ranges from 0-30 with higher scores indicating higher levels of cravings | Posted | Mean | Full Range | score on a scale | 30 days following surgery |
|
|
|
| Secondary | Opioid Misuse | Measured by the Current Opioid Misuse Measure ((COMM); scores can range from 0-68, scores of 9 or lower indicates a low risk of opioid misuse or abuse, scores higher than 9 indicate a high risk) | Posted | Mean | Full Range | score on a scale (COMM) | 1-3 hours prior to surgery |
|
|
|
| Secondary | Opioid Misuse | Measured by the Current Opioid Misuse Measure ((COMM); scores can range from 0-68, scores of 9 or lower indicates a low risk of opioid misuse or abuse, scores higher than 9 indicate a high risk) | Posted | Mean | Full Range | score on a scale (COMM) | 30 days following surgery |
|
|
|
| Secondary | Opioid Relapse | Patient reported use of non-prescribed opioids | Posted | Number | number of patients reporting relapse | 30 days following surgery |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Buprenorphine Full Dose Continuation | Patients instructed to continue taking the full prescribed dose of buprenorphine. Buprenorphine: Patients randomized to this group will continue their buprenorphine at the full prescribed dose. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Highest |
|
| Highest |
|