Status:
TERMINATED
Cranial Blocks for Postoperative Anesthesia
Lead Sponsor:
University of Pennsylvania
Conditions:
Craniotomy Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study compares the standard of care to the standard of care plus the administration of bupivacaine or liposomal bupivacaine in patients receiving craniotomies.
Detailed Description
Objective: To assess the effectiveness of analgesia by scalp nerve block with various agents in the first 72 hours following elective craniotomy. The investigators will employ a randomized, single-bl...
Eligibility Criteria
Inclusion
- ≥18 years of age
- Need for elective supratentorial craniotomy
- Preoperative GCS \> 13
Exclusion
- Preoperative GCS ≤ 13
- Child (\<18 years of age)
- Inability to understand or use the visual analog scale (VAS)
- Proven or suspected allergy to local anesthetics
- Craniotomy incision extending beyond the field of the block
- Patients chronically (more than 2 wk) treated with narcotic medications
- Previous scalp incision
- Bilateral craniotomies
- Allergies to local anesthetics
- GCS verbal score \< 4 after extubation
- Patients whose surgeries extend past 6 hours (will be placed on standard of care and removed from study)
- Patients currently on ergot-type oxytoxic drugs, MAOIs, or certain antidepressants
- Lactating Mothers
Key Trial Info
Start Date :
September 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2021
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04749797
Start Date
September 2 2020
End Date
July 20 2021
Last Update
September 13 2023
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104