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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-0712 | Other Identifier | IRB ID | |
| A530900 | Other Identifier | UW Madison | |
| SMPH/ANESTHESIOLOGY | Other Identifier | UW Madison |
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This study will evaluate the effectiveness of an aggressive multimodal regimen versus standard multimodal for Anterior Cruciate Ligament (ACL) repair using hamstring graft for patients having surgery in our outpatient surgicenter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multimodal:acetaminophen, gabapentin, ketamine, bupivacaine | Experimental | aggressive multimodal plus standard care, which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane |
|
| placebo pills and injectables | Placebo Comparator | standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multimodal:acetaminophen, gabapentin, ketamine, bupivacaine | Drug | acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption in the Immediate Postoperative Period | This data will be entered into the participants electronic medical record and collected from their chart once the participant has been discharged. The "immediate postoperative period" covers the participant's entire time in the outpatient surgery center after they have entered the recovery room postoperatively. The amount of time they remain in the outpatient surgery center postoperatively varies from a minimum of 1 hour to a maximum of 10 hours and an average of 4 hours. | Up to 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores During Recovery | Pain scores during recovery period through the first 24 hours of recovery, recorded upon arrival to recovery room, 1-hr post-op, 24-hrs post-op. This outcome reports lowest and highest pain score since discharge to 24 hour phone call. Pain scores are collected verbally on a scale of 0-10 where 10 is the most severe pain. | up to 24 hours postoperatively |
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Inclusion Criteria:
Patients of orthopedic surgeons on the study team scheduled for ACL repair using hamstring graft from the same leg will be considered for inclusion in this study. Other inclusion criteria are as follows:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John A Shepler | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | aggressive multimodal plus standard care, which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane multimodal:acetaminophen, gabapentin, ketamine, bupivacaine: acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane |
| FG001 | Placebo Pills and Injectables | standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane placebo pills and injectables: receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | aggressive multimodal plus standard care, which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane multimodal:acetaminophen, gabapentin, ketamine, bupivacaine: acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Opioid Consumption in the Immediate Postoperative Period | This data will be entered into the participants electronic medical record and collected from their chart once the participant has been discharged. The "immediate postoperative period" covers the participant's entire time in the outpatient surgery center after they have entered the recovery room postoperatively. The amount of time they remain in the outpatient surgery center postoperatively varies from a minimum of 1 hour to a maximum of 10 hours and an average of 4 hours. | Posted | Mean | Standard Deviation | morphine mg equivalents | Up to 10 hours |
|
up to 24 hours post-op
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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 | Multimodal:Acetaminophen, Gabapentin, Ketamine, Bupivacaine | aggressive multimodal plus standard care, which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane multimodal:acetaminophen, gabapentin, ketamine, bupivacaine: acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Light Headed After Surgery | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Shepler | University of Wisconsin - Madison | 608-263-8100 | jashepler@wisc.edu |
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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 | Aug 16, 2017 | Mar 13, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D007649 | Ketamine |
| D002045 | Bupivacaine |
| D007267 | Injections |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| placebo pills and injectables | Drug | receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds |
|
| Number of Participants Who Received Medication for Nausea | Number of participant who received medication for nausea prior to discharge and after discharge, up to 24 hours post-op. | Up to 24 hours following surgery |
| Post-Operative Incidence of Nausea | Incidence of nausea as recorded in the electronic medical record (EMR) in the recovery room through the first 24-hrs post-op. | Up to 24 hours following surgery |
| Post-Operative Nausea Scores | Nausea scores will be collected in post-operative recovery and 24 hours later (via phone). The participant will be asked to rate their nausea on a scale of 0 (no nausea) - 10 (worst possible). | Up to 24 hours following surgery |
| Incidence of Post-Operative Pruritus | Pruritus in recovery and through the first 24 hours post-op. | Up to 24 hours following surgery |
| Post-Operative Pruritis Score | Participants will be asked to rate their pruritis on a scale of 0 (no itching) - 10 (worst itchiness) while in post-op recovery room and then at 24 hours post-op via phone call. | Up to 24 hours following surgery |
| Sedation Scale | Sedation scale measured in recovery room, 1-hr post op, and 24 hrs op. The Sedation Scale is scored from 0-10 where 0 = normal, no sleepier than average, 10 = sleepy, hard to stay awake. | Up to 24 hours following surgery |
| Impact of Block Characteristics on Pain Control | Up to 24 hours following surgery |
| Intraoperative Medication Use: Ketorolac and Lidocaine | All participants received standard induction medications. | From induction until arrival in post anesthesia care unit. |
| Intraoperative Medication Use: Fentanyl | All participants received standard induction medications. | From induction until arrival in post anesthesia care unit. |
| Number of Participants With Complications From the Procedure | Up to 24 hours following surgery |
| Time to Discharge | Time to discharge from the recovery room (Phase I recovery) and the outpatient surgery center (Phase II recovery). | Up to 24 hours following surgery |
| BG001 | Placebo Pills and Injectables | standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane placebo pills and injectables: receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Smoking | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| ASA Physical Status | American Society of Anesthesiologists (ASA): ASA 1 - A normal healthy patient; ASA 2 - A patient with mild systemic disease | Count of Participants | Participants |
|
| OG001 | Placebo Pills and Injectables | standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane placebo pills and injectables: receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds |
|
|
| Secondary | Pain Scores During Recovery | Pain scores during recovery period through the first 24 hours of recovery, recorded upon arrival to recovery room, 1-hr post-op, 24-hrs post-op. This outcome reports lowest and highest pain score since discharge to 24 hour phone call. Pain scores are collected verbally on a scale of 0-10 where 10 is the most severe pain. | Posted | Mean | Standard Deviation | score on a scale | up to 24 hours postoperatively |
|
|
|
| Secondary | Number of Participants Who Received Medication for Nausea | Number of participant who received medication for nausea prior to discharge and after discharge, up to 24 hours post-op. | Posted | Count of Participants | Participants | Up to 24 hours following surgery |
|
|
|
| Secondary | Post-Operative Incidence of Nausea | Incidence of nausea as recorded in the electronic medical record (EMR) in the recovery room through the first 24-hrs post-op. | Posted | Count of Participants | Participants | Up to 24 hours following surgery |
|
|
|
| Secondary | Post-Operative Nausea Scores | Nausea scores will be collected in post-operative recovery and 24 hours later (via phone). The participant will be asked to rate their nausea on a scale of 0 (no nausea) - 10 (worst possible). | Posted | Mean | Standard Deviation | score on a scale | Up to 24 hours following surgery |
|
|
|
| Secondary | Incidence of Post-Operative Pruritus | Pruritus in recovery and through the first 24 hours post-op. | Posted | Count of Participants | Participants | Up to 24 hours following surgery |
|
|
|
| Secondary | Post-Operative Pruritis Score | Participants will be asked to rate their pruritis on a scale of 0 (no itching) - 10 (worst itchiness) while in post-op recovery room and then at 24 hours post-op via phone call. | Posted | Mean | Standard Deviation | score on a scale | Up to 24 hours following surgery |
|
|
|
| Secondary | Sedation Scale | Sedation scale measured in recovery room, 1-hr post op, and 24 hrs op. The Sedation Scale is scored from 0-10 where 0 = normal, no sleepier than average, 10 = sleepy, hard to stay awake. | Posted | Mean | Standard Deviation | score on a scale | Up to 24 hours following surgery |
|
|
|
| Secondary | Impact of Block Characteristics on Pain Control | This data was not collected. All participants had a femoral nerve block. The quality of this block was not assessed. | Posted | Up to 24 hours following surgery |
|
|
| Secondary | Intraoperative Medication Use: Ketorolac and Lidocaine | All participants received standard induction medications. | Posted | Mean | Standard Deviation | mg | From induction until arrival in post anesthesia care unit. |
|
|
|
| Secondary | Intraoperative Medication Use: Fentanyl | All participants received standard induction medications. | Posted | Mean | Standard Deviation | mcg | From induction until arrival in post anesthesia care unit. |
|
|
|
| Secondary | Number of Participants With Complications From the Procedure | Posted | Count of Participants | Participants | Up to 24 hours following surgery |
|
|
|
| Secondary | Time to Discharge | Time to discharge from the recovery room (Phase I recovery) and the outpatient surgery center (Phase II recovery). | Posted | Mean | Standard Deviation | minutes | Up to 24 hours following surgery |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Placebo Pills and Injectables | standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane placebo pills and injectables: receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds | 0 | 57 | 0 | 57 | 3 | 57 |
| Vivid Dreams | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
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| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| 1 hour post-op |
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| 24 hours post-op |
|