Back to resultsEffects of Scalp Nerve Block With Ropivacaine on Postoperative Recovery Quality
Primary Purpose
Meningioma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ropivacaine
saline
Sponsored by
About this trial
This is an interventional supportive care trial for Meningioma
Eligibility Criteria
Inclusion Criteria:
- 18-75 years old;
- BMI 18-28 kg/m2;
- ASA Physical Status 1-2;
- Clinical diagnosis of primary Meningeoma and will have elective Meningeoma Resection Surgery;
- With an estimated surgery time of less than 4h;
- The incision will be conducted at the frontal, top or the temperal skull.
Exclusion Criteria:
- A history of previous brain surgery;
- Severe systemic disease (heart, lung, kidney, or immune system);
- Nerval or mental disorders;
- A history of addiction to opioids;
- Allergic to ropivacaine;
- Infection at block site or severe systemic infection;
- Refuse to attend the trial.
Sites / Locations
- Renji Hospital affliated to Shanghai Jiaotong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ropivacaine
saline
Arm Description
After anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.5% ropivacaine
After anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.9% saline
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
serum TNF-α levels
an inflammatory mediator that reflects systemic inflammation
serum IL-6 levels
an inflammatory mediator that reflects systemic inflammation
serum IL-1β levels
an inflammatory mediator that reflects systemic inflammation
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.
white blood cell
serum white blood cell count
serum levels of CRP
inflammatory responses
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.
pain-relief medications
amounts of pain-relief medications
Hospitalization Days
length of hospitalization
out of pocket expenditure for hospitalisation
This reflects how much money the patient spends during hospitalisation
complications
incidence of intracranial infection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03648034
Brief Title
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
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningioma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ropivacaine
Arm Type
Experimental
Arm Description
After anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.5% ropivacaine
Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
After anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.9% saline
Intervention Type
Procedure
Intervention Name(s)
ropivacaine
Intervention Description
To perform scalp nerve blocks with ropivacaine
Intervention Type
Procedure
Intervention Name(s)
saline
Intervention Description
To perform scalp nerve blocks with saline
Primary Outcome Measure Information:
Title
KPS score
Description
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.
Time Frame
7 days post-surgery
Secondary Outcome Measure Information:
Title
KPS score
Description
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.
Time Frame
3 days post-surgery
Title
serum TNF-α levels
Description
an inflammatory mediator that reflects systemic inflammation
Time Frame
at 1h and 24h post-surgery
Title
serum IL-6 levels
Description
an inflammatory mediator that reflects systemic inflammation
Time Frame
at 1h and 24h post-surgery
Title
serum IL-1β levels
Description
an inflammatory mediator that reflects systemic inflammation
Time Frame
at 1h and 24h post-surgery
Title
Iowa Satisfaction with Anesthesia Scale (ISAS)
Description
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.
Time Frame
1 hour after the surgery is finished
Title
white blood cell
Description
serum white blood cell count
Time Frame
at 24 h after surgery
Title
serum levels of CRP
Description
inflammatory responses
Time Frame
at 24 h after surgery
Title
VAS score
Description
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.
Time Frame
at 1, 2 and 3 days post-surgery
Title
pain-relief medications
Description
amounts of pain-relief medications
Time Frame
at 1, 2 and 3 days post-surgery
Title
Hospitalization Days
Description
length of hospitalization
Time Frame
up to 30 days
Title
out of pocket expenditure for hospitalisation
Description
This reflects how much money the patient spends during hospitalisation
Time Frame
hospital discharge/up to 30 days
Title
complications
Description
incidence of intracranial infection
Time Frame
within 30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-75 years old;
BMI 18-28 kg/m2;
ASA Physical Status 1-2;
Clinical diagnosis of primary Meningeoma and will have elective Meningeoma Resection Surgery;
With an estimated surgery time of less than 4h;
The incision will be conducted at the frontal, top or the temperal skull.
Exclusion Criteria:
A history of previous brain surgery;
Severe systemic disease (heart, lung, kidney, or immune system);
Nerval or mental disorders;
A history of addiction to opioids;
Allergic to ropivacaine;
Infection at block site or severe systemic infection;
Refuse to attend the trial.
Facility Information:
Facility Name
Renji Hospital affliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
ZIP/Postal Code
200127
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of Scalp Nerve Block With Ropivacaine on Postoperative Recovery Quality
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