Effects of Scalp Nerve Block With Ropivacaine on Postoperative Recovery Quality

Effects of Preoperative Scalp Nerve Block on Postoperative Recovery Quality in Patients Undergoing Excision of Intracranial Meningioma

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.

Study Overview

• Status: Completed
• Conditions: Meningioma
• Intervention / Treatment: Procedure: ropivacaine; Procedure: saline

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.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200127
    • Renji Hospital affliated to Shanghai Jiaotong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ropivacaine; After anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.5% ropivacaine	Procedure: ropivacaine; To perform scalp nerve blocks with ropivacaine
Placebo Comparator: saline; After anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.9% saline	Procedure: saline; To perform scalp nerve blocks with saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 days post-surgery
serum TNF-α levels	an inflammatory mediator that reflects systemic inflammation	at 1h and 24h post-surgery
serum IL-6 levels	an inflammatory mediator that reflects systemic inflammation	at 1h and 24h post-surgery
serum IL-1β levels	an inflammatory mediator that reflects systemic inflammation	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.	1 hour after the surgery is finished
white blood cell	serum white blood cell count	at 24 h after surgery
serum levels of CRP	inflammatory responses	at 24 h after surgery
VAS score	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.	at 1, 2 and 3 days post-surgery
pain-relief medications	amounts of pain-relief medications	at 1, 2 and 3 days post-surgery
Hospitalization Days	length of hospitalization	up to 30 days
out of pocket expenditure for hospitalisation	This reflects how much money the patient spends during hospitalisation	hospital discharge/up to 30 days
complications	incidence of intracranial infection	within 30 days after surgery

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Meningioma; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: SNB20180813

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No