Clinical trial NCT03648034: Effects of Scalp Nerve Block With Ropivacaine on Postoperative Recovery Quality
Official title: Effects of Preoperative Scalp Nerve Block on Postoperative Recovery Quality in Patients Undergoing Excision of Intracranial Meningioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meningioma
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: KPS score
timeFrame: 7 days post-surgery
Secondary outcomes:
measure: KPS score
timeFrame: 3 days post-surgery
measure: serum TNF-α levels
timeFrame: at 1h and 24h post-surgery
measure: serum IL-6 levels
timeFrame: at 1h and 24h post-surgery
measure: serum IL-1β levels
timeFrame: at 1h and 24h post-surgery
measure: Iowa Satisfaction with Anesthesia Scale (ISAS)
timeFrame: 1 hour after the surgery is finished
measure: white blood cell
timeFrame: at 24 h after surgery
measure: serum levels of CRP
timeFrame: at 24 h after surgery
measure: VAS score
timeFrame: at 1, 2 and 3 days post-surgery
measure: pain-relief medications
timeFrame: at 1, 2 and 3 days post-surgery
measure: Hospitalization Days
timeFrame: up to 30 days
measure: out of pocket expenditure for hospitalisation
timeFrame: hospital discharge/up to 30 days
measure: complications
timeFrame: within 30 days after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital affliated to Shanghai Jiaotong University School of Medicine
Study officials:
References: