Meningioma
Conditions
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.
Interventions
PROCEDUREropivacaine
To perform scalp nerve blocks with ropivacaine
PROCEDUREsaline
To perform scalp nerve blocks with saline
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| serum TNF-α levels | at 1h and 24h post-surgery | an inflammatory mediator that reflects systemic inflammation |
| serum IL-6 levels | at 1h and 24h post-surgery | an inflammatory mediator that reflects systemic inflammation |
| serum IL-1β 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. |
| white blood cell | at 24 h after surgery | serum white blood cell count |
| 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. |
| 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 |
| 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 |
| complications | within 30 days after surgery | incidence of intracranial infection |
| serum levels of CRP | at 24 h after surgery | inflammatory responses |
Countries
China
Outcome results
None listed