Study Overview

The study is broadly divided into three phases:

Screening Phase

Potential participants are first assessed to make sure they fit the eligibility criteria. A total of 195 eligible participants will be included in the course of study.

Intervention Phase

Participants who fulfil the eligibility criteria are randomly assigned to one of the 3 groups. Every participant has an equal chance to get into one of these 3 groups. While the participants in each group receive a different intervention, the standard of care for all the participants is the same. All the participants are given around-the-clock pain medicine and the option for more pain medicine as needed. The purpose of creation of these groups is to assess the safety and efficacy of the active block (ropivacaine and dexamethasone) against saline/placebo. The intervention phase lasts 4 days and can be further divided into two phases:  

Double-blinded phase (Days 1 and 2)  

Open-label phase (Days 3 and 4)  

During the double-blinded phase (Days 1 and 2), both the doctors and participants are kept unaware of the drug being administered to prevent any bias and maintain the standard of care for all participants. Participants in group 1 receive an active block on Day 1 and saline/placebo on Day 2. Participants in group 2 receive saline/placebo on Day 1 and active block on Day 2. While participants in group 3 receive saline/placebo on both the days. During the open-label phase, participants can opt to receive the active block. Hourly pain scores are calculated on an 11-point numeric pain scale daily and a record of opioid use requirements is also kept for all participants. Participants are closely monitored for any adverse events via a series of assessments and imaging studies throughout the duration of their hospital stay. Vasospasm (constriction of blood vessels causing decreased blood supply) is one of the delayed complications of SAH and can potentially lead to irreversible brain damage (if not detected and managed early). Transcranial Doppler (TCD) is an ultrasonographic procedure that captures vasospasm early by measuring the speed of blood flow through the blood vessels. We perform a TCD within 3 hours before and within 6 hours after the PPF-injection in addition to daily TCDs. If vasospasm is detected on TCD before the PPF-injection, participants are not administered a PPF-injection for their safety. Computed tomography angiography (CTA) is another imaging technique that can diagnose vasospasm and be used as an alternative to TCD. 

Participants can withdraw from the study at any time. An investigator may also decide to remove a participant from the study if it is determined that their involvement in it poses even the tiniest risk to their health or if their health is already being negatively impacted by other factors.

Followup Phase

After the intervention phase, participants are still closely monitored for headaches, pain scores on 11-point numeric pain scale, opioid use requirements, and any adverse events throughout their hospital stay. After discharge from hospital, participants are followed-up at 3 months via an in-person meeting or a phone call. 

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