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

Not Applicable

• Conditions: Supratentorial Neoplasms

• Registration Number: NCT04344132
• Lead Sponsor: University of Roma La Sapienza

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-30
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-14
• Last Update Submitted: 2020-04-14
• Last Update Posted: 2020-04-15
• Study Start: 2020-04-20
• Primary Completion: 2020-11-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale score at 24 h after surgery	up to 24 hours	Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain),

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale score at 0	Baseline	Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
Visual Analogue Scale score at 2 hours	up to 2 hours	Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
Visual Analogue Scale score at 6 hours	up to 6 hours	Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
Visual Analogue Scale score at 12 hours	up to 12 hours	Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)
time first request of a patient for rescue analgesia	during surgery
awakening time	time from the end of surgery to awekening
changes in hemodynamics at mayfiled headfraom positioning	surgery	changes in heart rate
intraoperative anesthetics	during surgery time	(and opioids consumption)