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| Name | Class |
|---|---|
| Berry Consultants | OTHER |
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This REMAP Periop ERP domain study falls under the Periop Core Protocol, which compares the different recommended strategies for enhancing recovery through the use of various standard of care treatments before, during and after surgery in all patients with elective surgical encounters at UPMC who meet eligibility criteria.
The ERP domain seeks to enhance recovery by optimizing strategies of perioperative care through evaluating combinations of perioperative treatment, which consists of preoperative, intraoperative and postoperative care. Optimal combinations of perioperative care will be generated and analyzed to determine the best outcomes for patients as defined by reduction in hospital free days, reduction in postoperative nausea and vomiting, and improved pain control.
The Periop Core Protocol is an administration structure designed to provide appropriate management of all aspects of the study, taking into account multiple factors including representation from clinics and hospitals that are participating in the trial, availability of skills and expertise related to trial conduct and statistical analysis, and content knowledge regarding acute illness, elective surgery, and the interventions that are being evaluated. Eligible patients will be randomized to a recommended set of standard of care treatments related to their surgery to identify those that improve outcomes as defined by hospital free days at 30 days from the date of the surgical encounter. The administration model is designed to provide effective operational and strategic management of the REMAP that operates in multiple UPMC facilities, is supported by multiple funding bodies and sponsors, and will evolve with addition of domains and interventions that are being evaluated.
The ERP domain under the Periop Core Protocol will evaluate the varying recommended combinations of perioperative treatments, in hopes to determine the optimal strategies for perioperative care based on surgery type and patient specific factors. In this study, patient care components within the preoperative, perioperative, and postoperative domains will be randomized with a machine learning REMAP technique. Optimal strategies combining the entire perioperative process will be analyzed that determine best outcomes for patients including hospital free days, reductions in postoperative nausea and vomiting, and improved pain control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PONV Optimal Prophylaxis & Neuraxial Analgesia | Active Comparator | PONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia Intrathecal Morphine |
|
| PONV Supraoptimal Prophylaxis & Neuraxial Analgesia | Active Comparator | PONV Pre-op
Induction -dexamethasone Emergence -ondansetron Analgesia Intrathecal morphine |
|
| PONV Supraoptimal Prophylaxis & Regional Analgesia Block 1 | Active Comparator | PONV Pre-op
Induction -dexamethasone Emergence -ondansetron Analgesia Paravertebral block |
|
| PONV Supraoptimal Prophylaxis & Regional Analgesia Block 2 | Active Comparator | PONV Pre-op
Induction -dexamethasone Emergence -ondansetron Analgesia QL1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuraxial Analgesia | Drug | This randomized group will receive a neuraxial morphine injection (intrathecal morphine/hydromorphone). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30 Day Hospital Free Days | The primary endpoint for this domain is the REMAP Periop primary outcome of hospital free days at 30 days after the elective surgical encounter. | Day 0 - Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Postoperative Nausea and Vomiting (PONV) by Measurement Incidences of Emesis Within 24 Hours Post Surgery | Did the participant receive postoperative antiemetic medication within 24 hours of completion of surgery (number of participants who did receive postoperative antiemetics) | 0 - 24 hours post-surgery |
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Inclusion Criteria
Exclusion Critera
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Esper, MD, MBA | University of Pittsburgh | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States | ||
| UPMC Presbyterian |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38154902 | Derived | Holder-Murray J, Esper SA, Althans AR, Knight J, Subramaniam K, Derenzo J, Ball R, Beaman S, Luke C, La Colla L, Schott N, Williams B, Lorenzi E, Berry LR, Viele K, Berry S, Masters M, Meister KA, Wilkinson T, Garrard W, Marroquin OC, Mahajan A. REMAP Periop: a randomised, embedded, multifactorial adaptive platform trial protocol for perioperative medicine to determine the optimal enhanced recovery pathway components in complex abdominal surgery patients within a US healthcare system. BMJ Open. 2023 Dec 28;13(12):e078711. doi: 10.1136/bmjopen-2023-078711. |
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De-identified participant-level data underlying the results reported in journal articles, subject to appropriate security controls, may be available for sharing with other researchers.
Relevant data may be available 1 year following publication.
Data access is subject to a methodically sound proposal and the necessary data sharing agreements.
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| ID | Title | Description |
|---|---|---|
| FG000 | PONV Optimal Prophylaxis & Neuraxial Analgesia | Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Intrathecal Morphine |
| FG001 | PONV Optimal Prophylaxis & Regional Analgesia Block 1 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 9, 2023 | Mar 5, 2026 |
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This study has 2 domains, and each domain has its own arms. Domain 1: postoperative nausea and vomiting (Optimal Prophylaxis and Supraoptimal prophylaxis). Domain 2: Analgesia (Neuraxial block, regional block 1, regional block 2, neuraxial & regional block 1, and neuraxial & regional block 2). Each patient is randomized to one intervention in each domain. The randomization for one domain does not influence the randomization in the other domain. The trial is adaptive, so if one arm is more successful than another arm, the randomization weights will shift to favor the more successful arm. Unsuccessful arms can be dropped from the trial.
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| PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 1 | Active Comparator | PONV Pre-op
Induction -dexamethasone Emergence -ondansetron Analgesia IT morphine and Paravertebral |
|
| PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 2 | Active Comparator | PONV Pre-op
Induction -dexamethasone Emergence -ondansetron Analgesia IT morphine and QL1 |
|
| PONV Optimal Prophylaxis & Regional Analgesia Block 1 | Active Comparator | PONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia Paravertebral Block |
|
| PONV Optimal Prophylaxis & Regional Analgesia Block 2 | Active Comparator | PONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia QL1 |
|
| PONV Optimal Prophylaxis and Neuraxial & Regional Analgesia Block 1 | Active Comparator | PONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia Intrathecal Morphine & Paravertebral Block |
|
| PONV Optimal Prophylaxis and Neuraxial & Regional Analgesia Block 2 | Active Comparator | PONV Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Analgesia Intrathecal Morphine & QL1 |
|
|
| Regional Block 1: Paravertebral | Drug | This randomized group will receive regional technique analgesia with sodium channel nerve blockade pharmacotherapy (ie nerve block) |
|
|
| Perphenazine | Drug | This randomized group will receive 8 mg of perphenazine orally preoperatively. |
|
| Aprepitant | Drug | This randomized group will receive 40 mg of aprepitant orally preoperatively. |
|
| Dimenhydrinate | Drug | This randomized group will receive 25 mg of dimenhydrinate orally preoperatively. |
|
| Ondansetron 4 MG | Drug | This randomized group will receive 4 mg of ondansetron orally. |
|
| Dexamethasone | Drug | This randomized group will receive 4-5 mg of dexamethasone intravenously. |
|
| Regional Block 2: QL1 | Drug | This randomized group will receive regional technique analgesia with sodium channel nerve blockade pharmacotherapy (ie nerve block) |
|
|
| Change in the Rate of Postoperative Opioid Use by Measurement of Oral Morphine Equivalents (OME) Measured 24 Hours After Surgery |
OME measurement is a method to compare and standardize different opioids administered to participants to account for varying strengths. OME is measured as a rate in milligrams per day and modeled as a continuous endpoint. For analysis purposes, OME was converted to log(OME) + 1 |
| 0-24 hours post-surgery |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| UPMC Passavant | Pittsburgh | Pennsylvania | 15237 | United States |
Pre-op
-perphenazine
Induction -dexamethasone
Emergence
-ondansetron
Paravertebral block
| FG002 | PONV Optimal Prophylaxis & Regional Analgesia Block 2 | Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron QL1 |
| FG003 | PONV Optimal Prophylaxis & Neuraxial and Regional Analgesia Block 1 | Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron IT morphine and Paravertebral |
| FG004 | PONV Optimal Prophylaxis & Neuraxial and Regional Analgesia Block 2 | Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron IT morphine and QL1 |
| FG005 | PONV Supraoptimal Prophylaxis & Neuraxial Analgesia | Pre-op
Induction -dexamethasone Emergence -ondansetron Intrathecal morphine |
| FG006 | PONV Supraoptimal Prophylaxis & Regional Analgesia Block 1 | Pre-op
Induction -dexamethasone Emergence -ondansetron Paravertebral block |
| FG007 | PONV Supraoptimal Prophylaxis & Regional Analgesia Block 2 | Pre-op
Induction -dexamethasone Emergence -ondansetron QL1 |
| FG008 | PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 1 | Pre-op
Induction -dexamethasone Emergence -ondansetron IT morphine and Paravertebral |
| FG009 | PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 2 | Pre-op
Induction -dexamethasone Emergence -ondansetron IT morphine and QL1 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PONV Optimal Prophylaxis & Neuraxial Analgesia | Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Intrathecal Morphine |
| BG001 | PONV Optimal Prophylaxis & Regional Analgesia Block 1 | Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Paravertebral block |
| BG002 | PONV Optimal Prophylaxis & Regional Analgesia Block 2 | Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron QL1 |
| BG003 | PONV Optimal Prophylaxis & Neuraxial and Regional Analgesia Block 1 | Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron IT morphine and Paravertebral |
| BG004 | PONV Optimal Prophylaxis & Neuraxial and Regional Analgesia Block 2 | Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron IT morphine and QL1 |
| BG005 | PONV Supraoptimal Prophylaxis & Neuraxial Analgesia | Pre-op
Induction -dexamethasone Emergence -ondansetron Intrathecal morphine |
| BG006 | PONV Supraoptimal Prophylaxis & Regional Analgesia Block 1 | Pre-op
Induction -dexamethasone Emergence -ondansetron Paravertebral block |
| BG007 | PONV Supraoptimal Prophylaxis & Regional Analgesia Block 2 | Pre-op
Induction -dexamethasone Emergence -ondansetron QL1 |
| BG008 | PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 1 | Pre-op
Induction -dexamethasone Emergence -ondansetron IT morphine and Paravertebral |
| BG009 | PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 2 | Pre-op
Induction -dexamethasone Emergence -ondansetron IT morphine and QL1 |
| BG010 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | 30 Day Hospital Free Days | The primary endpoint for this domain is the REMAP Periop primary outcome of hospital free days at 30 days after the elective surgical encounter. | Each participant was assigned an arm/intervention for the PONV domain and Analgesia domain. To make sure 1 participant was not counted twice, we had to arrange the participant flow by each of the possible combinations instead of separately. It was pre-specified to report the data for Outcome Measure 1 per individual intervention and not by combination. | Posted | Median | Inter-Quartile Range | Number of hospital free days | Day 0 - Day 30 |
|
|
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Postoperative Nausea and Vomiting (PONV) by Measurement Incidences of Emesis Within 24 Hours Post Surgery | Did the participant receive postoperative antiemetic medication within 24 hours of completion of surgery (number of participants who did receive postoperative antiemetics) | Each participant was assigned an arm/intervention for the PONV domain and Analgesia domain. To make sure 1 participant was not counted twice, we had to arrange the participant flow by each of the possible combinations instead of separately. The different domains were analyzed separately though. They were not analyzed as a combination. This analysis only included the PONV domain because the measure is specific to PONV and does not involve analgesia. | Posted | Count of Participants | Participants | 0 - 24 hours post-surgery |
|
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in the Rate of Postoperative Opioid Use by Measurement of Oral Morphine Equivalents (OME) Measured 24 Hours After Surgery | OME measurement is a method to compare and standardize different opioids administered to participants to account for varying strengths. OME is measured as a rate in milligrams per day and modeled as a continuous endpoint. For analysis purposes, OME was converted to log(OME) + 1 | Each participant was assigned an arm/intervention for the PONV domain and Analgesia domain. To make sure 1 participant was not counted twice, we had to arrange the participant flow by each of the possible combinations instead of separately. The different domains were analyzed separately though. They were not analyzed as a combination. This analysis only included the analgesia domain because the measure is specific to analgesia and does not involve PONV. | Posted | Mean | Standard Deviation | mg/day | 0-24 hours post-surgery |
|
from enrollment until 30 days after surgery
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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 | PONV Optimal Prophylaxis & Neuraxial Analgesia | Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Intrathecal Morphine | 2 | 113 | 0 | 113 | 0 | 113 |
| EG001 | PONV Optimal Prophylaxis & Regional Analgesia Block 1 | Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron Paravertebral block | 1 | 116 | 0 | 116 | 0 | 116 |
| EG002 | PONV Optimal Prophylaxis & Regional Analgesia Block 2 | Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron QL1 | 1 | 112 | 0 | 112 | 0 | 112 |
| EG003 | PONV Optimal Prophylaxis & Neuraxial and Regional Analgesia Block 1 | Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron IT morphine and Paravertebral | 0 | 121 | 0 | 121 | 0 | 121 |
| EG004 | PONV Optimal Prophylaxis & Neuraxial and Regional Analgesia Block 2 | Pre-op -perphenazine Induction -dexamethasone Emergence -ondansetron IT morphine and QL1 | 2 | 118 | 0 | 118 | 0 | 118 |
| EG005 | PONV Supraoptimal Prophylaxis & Neuraxial Analgesia | Pre-op
Induction -dexamethasone Emergence -ondansetron Intrathecal morphine | 0 | 157 | 0 | 157 | 0 | 157 |
| EG006 | PONV Supraoptimal Prophylaxis & Regional Analgesia Block 1 | Pre-op
Induction -dexamethasone Emergence -ondansetron Paravertebral block | 0 | 130 | 0 | 130 | 0 | 130 |
| EG007 | PONV Supraoptimal Prophylaxis & Regional Analgesia Block 2 | Pre-op
Induction -dexamethasone Emergence -ondansetron QL1 | 2 | 136 | 0 | 136 | 0 | 136 |
| EG008 | PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 1 | Pre-op
Induction -dexamethasone Emergence -ondansetron IT morphine and Paravertebral | 3 | 1,581 | 0 | 1,581 | 0 | 1,581 |
| EG009 | PONV Supraoptimal Prophylaxis & Neuraxial and Regional Analgesia Block 2 | Pre-op
Induction -dexamethasone Emergence -ondansetron IT morphine and QL1 | 2 | 393 | 0 | 393 | 0 | 393 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Holder-Murray, MD, FACS, FASCRS | UPMC | 8876847189 | holdermurrayjm@upmc.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Postoperative Nausea and Vomiting Domain SAP | Mar 7, 2024 | Mar 5, 2026 | SAP_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: PONV Adaptive Design Report | Jun 14, 2023 | May 1, 2026 | SAP_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Analgesia Domain SAP | Feb 21, 2025 | Mar 5, 2026 | SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Analgesia Adaptive Design Report | Jun 14, 2023 | May 1, 2026 | SAP_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Core Adaptive Design Report | Jun 14, 2013 | May 1, 2026 | SAP_005.pdf |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| D009407 | Nerve Block |
| D010546 | Perphenazine |
| D000077608 | Aprepitant |
| D004111 | Dimenhydrinate |
| D017294 | Ondansetron |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| 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 |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004155 | Diphenhydramine |
| D005021 | Ethylamines |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013806 | Theophylline |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013259 | Steroids, Fluorinated |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| OG003 |
| Neuraxial and Regional Analgesia Block 1 |
IT morphine and Paravertebral |
| OG004 | Neuraxial and Regional Analgesia Block 2 | IT morphine and QL1 |
|
|