Effects of Scalp Nerve Block With Ropivacaine on Postoperative Recovery Quality

RenJi Hospital144 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

144

Conditions

Meningioma

Interventions

ropivacainePROCEDURE

To perform scalp nerve blocks with ropivacaine

salinePROCEDURE

To perform scalp nerve blocks with saline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Renji Hospital affliated to Shanghai Jiaotong University School of Medicine

Shanghai, China

Outcomes

Primary Outcomes

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.

Time frame: 7 days post-surgery

Secondary Outcomes

KPS score

Time frame: 3 days post-surgery

serum TNF-α levels

an inflammatory mediator that reflects systemic inflammation

Time frame: at 1h and 24h post-surgery

serum IL-6 levels

an inflammatory mediator that reflects systemic inflammation

Time frame: at 1h and 24h post-surgery

serum IL-1β levels

an inflammatory mediator that reflects systemic inflammation

Time frame: at 1h and 24h post-surgery

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.

Time frame: 1 hour after the surgery is finished

white blood cell

serum white blood cell count

Time frame: at 24 h after surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.