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 |
|---|---|---|---|---|---|---|---|---|
| Single Injection of Bupivacaine | Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane. Bupivacaine: 60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block. | 0 | None | 0 | 3 | 0 | 3 | View |
| Single Injection of Exparel® | Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane Exparel®: 20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block. | 0 | None | 0 | 6 | 0 | 6 | View |
| Continuous Infusion of Ropivacaine | Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump Ropivacaine: 40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side. | 0 | None | 0 | 4 | 0 | 4 | View |