Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Adductor Canal Block | Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB. Adductor canal block: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU. Bupivacaine: Used in spinal anesthetic Fentanyl: May or may not be used in spinal anesthetic Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block. | 0 | None | 0 | 60 | 0 | 60 | View |
| Adductor Canal Block With Dexamethasone | Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their ACB along with 8mg IV dexamethasone. Adductor canal block with dexamethasone: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU. Bupivacaine: Used in spinal anesthetic Fentanyl: May or may not be used in spinal anesthetic Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block. Dexamethasone: To be given intravenously at time of nerve block to one of the study arms. | 0 | None | 0 | 60 | 0 | 60 | View |
| Adductor Canal Catheter | Postoperatively in the PACU, this group will receive 20ml 0.5% ropivacaine for their adductor canal block and have a catheter placed in the adductor canal at the mid-thigh. 0.2% ropivacaine at 5ml/hr will be run for 48 hours. Adductor canal catheter: Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started. Bupivacaine: Used in spinal anesthetic Fentanyl: May or may not be used in spinal anesthetic Ropivacaine 0.5% Injectable Solution: Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block. | 0 | None | 0 | 57 | 0 | 57 | View |