Effects of Scalp Nerve Block With Ropivacaine on Postoperative Recovery Quality

Shanghai Jiao Tong University

Status: Completed

Conditions: Meningioma

Treatments: Procedure: ropivacaine; Procedure: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03648034

SNB20180813

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 2 patient groups, including a placebo group

ropivacaine

Experimental group

Description:

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

Treatment:

Procedure: ropivacaine

saline

Placebo Comparator group

Description:

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

Treatment:

Procedure: saline