Effects of Scalp Nerve Block With Ropivacaine on Postoperative Recovery Quality

Not Applicable

Completed

• Conditions: Meningioma
• Interventions: Procedure: ropivacaine; Procedure: saline

• Registration Number: NCT03648034
• Lead Sponsor: RenJi Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-27
• Study Start: 2018-09-18
• Primary Completion: 2019-09-30
• Study Completion: 2019-11-30
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ropivacaine	ropivacaine	After anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.5% ropivacaine
saline	saline	After anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.9% saline

Primary Outcome Measures

Name	Time	Method
KPS score	7 days post-surgery	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.

Secondary Outcome Measures

Name	Time	Method
serum levels of CRP	at 24 h after surgery	inflammatory responses
serum TNF-α levels	at 1h and 24h post-surgery	an inflammatory mediator that reflects systemic inflammation
Hospitalization Days	up to 30 days	length of hospitalization
out of pocket expenditure for hospitalisation	hospital discharge/up to 30 days	This reflects how much money the patient spends during hospitalisation
KPS score	3 days post-surgery	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.
white blood cell	at 24 h after surgery	serum white blood cell count
serum IL-1β levels	at 1h and 24h post-surgery	an inflammatory mediator that reflects systemic inflammation
VAS score	at 1, 2 and 3 days post-surgery	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.
pain-relief medications	at 1, 2 and 3 days post-surgery	amounts of pain-relief medications
serum IL-6 levels	at 1h and 24h post-surgery	an inflammatory mediator that reflects systemic inflammation
Iowa Satisfaction with Anesthesia Scale (ISAS)	1 hour after the surgery is finished	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.
complications	within 30 days after surgery	incidence of intracranial infection

Trial Locations

Locations (1)

Renji Hospital affliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China