Effects of Scalp Nerve Block With Ropivacaine on Postoperative Recovery Quality

NCT ID: NCT03648034

Last Updated: 2020-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-18
• Study Completion Date: 2019-11-30

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.

Conditions

Meningioma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

ropivacaine

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

Group Type: EXPERIMENTAL

ropivacaine

Intervention Type: PROCEDURE

To perform scalp nerve blocks with ropivacaine

saline

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

Group Type: PLACEBO_COMPARATOR

saline

Intervention Type: PROCEDURE

To perform scalp nerve blocks with saline

Interventions

ropivacaine

To perform scalp nerve blocks with ropivacaine

Intervention Type: PROCEDURE

saline

To perform scalp nerve blocks with saline

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jie Tian

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Renji Hospital affliated to Shanghai Jiaotong University School of Medicine

Shanghai, , China

Countries

China

Other Identifiers

SNB20180813

Identifier Type: -

Identifier Source: org_study_id