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Effects of Scalp Nerve Block With Ropivacaine on Postoperative Recovery Quality

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648034
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Jie Tian, RenJi Hospital

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.

Condition or disease Intervention/treatment Phase
Meningioma Procedure: ropivacaine Procedure: saline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Preoperative Scalp Nerve Block on Postoperative Recovery Quality in Patients Undergoing Excision of Intracranial Meningioma
Actual Study Start Date : September 18, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. KPS score [ Time Frame: 7 days post-surgery ]
    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 :
  1. KPS score [ Time Frame: 3 days post-surgery ]
    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.

  2. serum TNF-α levels [ Time Frame: at 1h and 24h post-surgery ]
    an inflammatory mediator that reflects systemic inflammation

  3. serum IL-6 levels [ Time Frame: at 1h and 24h post-surgery ]
    an inflammatory mediator that reflects systemic inflammation

  4. serum IL-1β levels [ Time Frame: at 1h and 24h post-surgery ]
    an inflammatory mediator that reflects systemic inflammation

  5. Iowa Satisfaction with Anesthesia Scale (ISAS) [ Time Frame: 1 hour after the surgery is finished ]
    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.

  6. white blood cell [ Time Frame: at 24 h after surgery ]
    serum white blood cell count

  7. serum levels of CRP [ Time Frame: at 24 h after surgery ]
    inflammatory responses

  8. VAS score [ Time Frame: at 1, 2 and 3 days post-surgery ]
    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.

  9. pain-relief medications [ Time Frame: at 1, 2 and 3 days post-surgery ]
    amounts of pain-relief medications

  10. Hospitalization Days [ Time Frame: up to 30 days ]
    length of hospitalization

  11. out of pocket expenditure for hospitalisation [ Time Frame: hospital discharge/up to 30 days ]
    This reflects how much money the patient spends during hospitalisation

  12. complications [ Time Frame: within 30 days after surgery ]
    incidence of intracranial infection



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648034


Contacts
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Contact: jie Tian 8618616206596 vaseline2001@hotmail.com

Locations
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China
Renji Hospital affliated to Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, China, 200127
Contact: JIE TIAN    862168383702      
Sponsors and Collaborators
RenJi Hospital

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Responsible Party: Jie Tian, Principal Investigator, RenJi Hospital
ClinicalTrials.gov Identifier: NCT03648034    
Other Study ID Numbers: SNB20180813
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Meningioma
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents