Effects of Scalp Nerve Blocks on Systemic Inflammation

Meningiomas Clinical Trial

Official title:

Effects of Scalp Nerve Blocks on Systemic Inflammation After Meningeoma Resection Surgery：a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02939833
• Other study ID #: NB20161010
• Status: Not yet recruiting
• Phase: N/A
• First received: October 11, 2016
• Last updated: October 18, 2016
• Start date: January 2017
• Est. completion date: October 2019

Study information

• Verified date: October 2016
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Patients undergoing meningeoma resection surgery will be randomly assigned to two groups. One group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will receive scalp nerve blocks with 0.9% saline after anesthesia induction and before skull-pin insertion. Serum levels of TNF-α、IL-6 and IL-1β will be measured and compared at before surgery, 1h, 24h and 72h after surgery, respectively. VAS score, dosage of pain-control medicine and NRS score at the first three days after surgery, ratio of intracranial infection within 30d after surgery, and total hospitalization days and medical expenditure will also be recorded and compared between the two groups.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: October 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI 18-28 kg/m2 ASA Physical Status 1-2 diagnosed Meningeoma and will have selective Meningeoma Resection Surgery the incision will be conducted at the frontal, top or the temperal skull.

Exclusion Criteria:

• previous brain surgery severe systemic disease (heart, lung, kidney, or immune system) nerval or mental disorders a history of addiction to opioids allergic to ropivacaine infection at block site or severe systemic infection refuse to attend the trial

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Meningioma
• Meningiomas

Intervention

Procedure:
• Scalp Nerve Blocks With Ropivacaine

• Scalp Nerve Blocks With Saline

Locations

Country	Name	City	State
China	Shanghai Renji hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum TNF-a level		24 hour after surgery	No
Primary	serum IL-6 level		24 hour after surgery	No
Primary	serum IL-1ß level		24 hour after surgery	No
Secondary	serum TNF-a level		1 hour after surgery	No
Secondary	serum IL-6 level		1 hour after surgery	No
Secondary	serum IL-1ß level		1 hour after surgery	No
Secondary	serum TNF-a level		72 hour after surgery	No
Secondary	serum IL-6 level		72 hour after surgery	No
Secondary	serum IL-1ß level		72 hour after surgery	No
Secondary	VAS score		24 hour after surgery	No
Secondary	VAS score		48 hour after surgery	No
Secondary	VAS score		72 hour after surgery	No
Secondary	dosage of pain-control medicine		within 72 hour after surgery	No
Secondary	NRS score		24 hour after surgery	No
Secondary	NRS score		48 hour after surgery	No
Secondary	NRS score		72 hour after surgery	No
Secondary	incidence of intracranial infection		within 30 days after surgery	No
Secondary	Hospitalization Days		up to 30 days	No
Secondary	out of pocket expenditure for hospitalisation		hospital discharge/up to 30 days	No