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

Supratentorial Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04344132
• Other study ID #: URom
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 20, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: April 2020
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Supratentorial Neoplasms

Intervention

Procedure:
• Scalp Block
standard practice of controll the pain after surgery. Block of the nerve emergences.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

References & 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. — View Citation

Tsaousi 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analogue Scale score at 0	Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)	Baseline
Secondary	Visual Analogue Scale score at 2 hours	Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)	up to 2 hours
Secondary	Visual Analogue Scale score at 6 hours	Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)	up to 6 hours
Secondary	Visual Analogue Scale score at 12 hours	Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)	up to 12 hours
Secondary	time first request of a patient for rescue analgesia		during surgery
Secondary	intraoperative anesthetics	(and opioids consumption)	during surgery time
Secondary	awakening time		time from the end of surgery to awekening
Secondary	changes in hemodynamics at mayfiled headfraom positioning	changes in term of blood pressure	surgery
Secondary	changes in hemodynamics at mayfiled headfraom positioning	changes in heart rate	surgery