Pre- vs. Postoperative Scalp Block for Pain Control After Supratentorial Craniotomy
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
Study was designed to evaluate optimal timing for selective scalp block in patients undergoing general anesthesia for supratentorial craniotomy.Pain score assessed by visual analog scale (VAS) preoperatively (baseline) and after extubation at 2, 6, 12 and 24 hours; time first request of a patient for rescue analgesia; intraoperative anesthetics and opioids consumption; awakening time; perioperative complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2020
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2020
CompletedFirst Posted
Study publicly available on registry
April 14, 2020
CompletedStudy Start
First participant enrolled
April 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedApril 15, 2020
April 1, 2020
7 months
March 30, 2020
April 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Analogue Scale score at 24 h after surgery
Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain),
up to 24 hours
Secondary Outcomes (9)
Visual Analogue Scale score at 0
Baseline
Visual Analogue Scale score at 2 hours
up to 2 hours
Visual Analogue Scale score at 6 hours
up to 6 hours
Visual Analogue Scale score at 12 hours
up to 12 hours
time first request of a patient for rescue analgesia
during surgery
- +4 more secondary outcomes
Interventions
standard practice of controll the pain after surgery. Block of the nerve emergences.
Eligibility Criteria
You may qualify if:
- Adult patients (\>18 years),
- presenting with supratentorial brain tumors scheduled for elective craniotomy under general anesthesia
You may not qualify if:
- history of allergic reactions on local anesthetics;
- ASA status ≥ 3;
- depressed consciousness in pre- or postoperative period;
- aphasia (as investigators were not able to obtain VAS score).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Bebawy JF, Bilotta F, Koht A. A modified technique for auriculotemporal nerve blockade when performing selective scalp nerve block for craniotomy. J Neurosurg Anesthesiol. 2014 Jul;26(3):271-2. doi: 10.1097/ANA.0000000000000032. No abstract available.
PMID: 24492515BACKGROUNDTsaousi GG, Logan SW, Bilotta F. Postoperative Pain Control Following Craniotomy: A Systematic Review of Recent Clinical Literature. Pain Pract. 2017 Sep;17(7):968-981. doi: 10.1111/papr.12548. Epub 2017 Feb 23.
PMID: 27996204BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 30, 2020
First Posted
April 14, 2020
Study Start
April 20, 2020
Primary Completion
November 30, 2020
Study Completion
December 30, 2020
Last Updated
April 15, 2020
Record last verified: 2020-04