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Pre- vs. Postoperative Scalp Block for Pain Control After Supratentorial Craniotomy

Pre- vs. Postoperative Scalp Block for Pain Control After Supratentorial Craniotomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04344132
Enrollment
50
Registered
2020-04-14
Start date
2020-04-20
Completion date
2020-12-30
Last updated
2020-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Supratentorial Neoplasms

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.

Interventions

PROCEDUREScalp Block

standard practice of controll the pain after surgery. Block of the nerve emergences.

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients (\>18 years), * presenting with supratentorial brain tumors scheduled for elective craniotomy under general anesthesia

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frameDescription
Visual Analogue Scale score at 24 h after surgeryup to 24 hoursVisual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain),

Secondary

MeasureTime frameDescription
Visual Analogue Scale score at 2 hoursup to 2 hoursVisual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
Visual Analogue Scale score at 6 hoursup to 6 hoursVisual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
Visual Analogue Scale score at 12 hoursup to 12 hoursVisual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
Visual Analogue Scale score at 0BaselineVisual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
intraoperative anestheticsduring surgery time(and opioids consumption)
awakening timetime from the end of surgery to awekening
changes in hemodynamics at mayfiled headfraom positioningsurgerychanges in term of blood pressure
time first request of a patient for rescue analgesiaduring surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026