Effects of Scalp Nerve Block With Ropivacaine on Postoperative Recovery Quality

Meningioma Clinical Trial

Official title:

Effects of Preoperative Scalp Nerve Block on Postoperative Recovery Quality in Patients Undergoing Excision of Intracranial Meningioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03648034
• Other study ID #: SNB20180813
• Status: Completed
• Phase: N/A
• Start date: September 18, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: April 2020
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients undergoing elective meningeoma resection surgery will be randomly assigned to one of the following two groups. After anesthesia induction but before skull-pin insertion, one group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will receive scalp nerve blocks with 0.9% saline. The patients' postoperative recovery quality, which is evaluated by KPS score, peri-operative inflammatory responses, and post-operative pain degree will be evaluated and compared between the two groups.

Description:

Patients undergoing elective meningeoma resection surgery will be randomly assigned to one of the following two groups. After anesthesia induction but before skull-pin insertion, one group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will receive scalp nerve blocks with 0.9% saline. The patients' KPS scores at 3d after surgery and at discharge, serum levels of TNF-α、IL-6，IL-1β at 24h after surgery, satisfaction score after recovery, and VAS scores at 1, 2, 3 days post-surgery will be evaluated and compared between the two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: November 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 18-75 years old;

2. BMI 18-28 kg/m2;

3. ASA Physical Status 1-2;

4. Clinical diagnosis of primary Meningeoma and will have elective Meningeoma Resection Surgery;

5. With an estimated surgery time of less than 4h;

6. The incision will be conducted at the frontal, top or the temperal skull.

Exclusion Criteria:

1. A history of previous brain surgery;

2. Severe systemic disease (heart, lung, kidney, or immune system);

3. Nerval or mental disorders;

4. A history of addiction to opioids;

5. Allergic to ropivacaine;

6. Infection at block site or severe systemic infection;

7. Refuse to attend the trial.

Related Conditions & MeSH terms

• Meningioma

Intervention

Procedure:
• ropivacaine
To perform scalp nerve blocks with ropivacaine
• saline
To perform scalp nerve blocks with saline

Locations

Country	Name	City	State
China	Renji Hospital affliated to Shanghai Jiaotong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KPS score	Karnofsky performance score (KPS) allows patients to be classified as to their functional impairment. The total scale range is 0-100. The lower the KPS score, the worse the survival for most serious illnesses.	7 days post-surgery
Secondary	KPS score	Karnofsky performance score (KPS) allows patients to be classified as to their functional impairment. The total scale range is 0-100. The lower the KPS score, the worse the survival for most serious illnesses.	3 days post-surgery
Secondary	serum TNF-a levels	an inflammatory mediator that reflects systemic inflammation	at 1h and 24h post-surgery
Secondary	serum IL-6 levels	an inflammatory mediator that reflects systemic inflammation	at 1h and 24h post-surgery
Secondary	serum IL-1ß levels	an inflammatory mediator that reflects systemic inflammation	at 1h and 24h post-surgery
Secondary	Iowa Satisfaction with Anesthesia Scale (ISAS)	Iowa Satisfaction with Anesthesia Scale (ISAS) comprises of 11 items to measure patient satisfaction after surgery. The total scale range is -33-+33. The higher the ISAS score, the better the satisfaction level.	1 hour after the surgery is finished
Secondary	white blood cell	serum white blood cell count	at 24 h after surgery
Secondary	serum levels of CRP	inflammatory responses	at 24 h after surgery
Secondary	VAS score	The visual analogue scale or visual analog scale (VAS) measures the average intensity of pain in the past on a 0-to-10 scale, where 0 = No pain and 10 = Pain as intense as you can imagine.	at 1, 2 and 3 days post-surgery
Secondary	pain-relief medications	amounts of pain-relief medications	at 1, 2 and 3 days post-surgery
Secondary	Hospitalization Days	length of hospitalization	up to 30 days
Secondary	out of pocket expenditure for hospitalisation	This reflects how much money the patient spends during hospitalisation	hospital discharge/up to 30 days
Secondary	complications	incidence of intracranial infection	within 30 days after surgery