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Effects of Scalp Nerve Blocks on Systemic Inflammation

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ClinicalTrials.gov Identifier: NCT02939833
Recruitment Status : Not yet recruiting
First Posted : October 20, 2016
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Brief Summary:
Patients undergoing meningeoma resection surgery will be randomly assigned to two groups. One group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will receive scalp nerve blocks with 0.9% saline after anesthesia induction and before skull-pin insertion. Serum levels of TNF-α、IL-6 and IL-1β will be measured and compared at before surgery, 1h, 24h and 72h after surgery, respectively. VAS score, dosage of pain-control medicine and NRS score at the first three days after surgery, ratio of intracranial infection within 30d after surgery, and total hospitalization days and medical expenditure will also be recorded and compared between the two groups.

Condition or disease Intervention/treatment Phase
Meningiomas Procedure: Scalp Nerve Blocks With Ropivacaine Procedure: Scalp Nerve Blocks With Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Scalp Nerve Blocks on Systemic Inflammation After Meningeoma Resection Surgery:a Prospective Randomized Controlled Trial
Study Start Date : January 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ropivacaine
patients in this group will receive scalp nerve blocks with 0.5% ropivacaine after anesthesia induction and before skull-pin insertion
Procedure: Scalp Nerve Blocks With Ropivacaine
Placebo Comparator: saline
patients in this group will receive scalp nerve blocks with 0.9% saline after anesthesia induction and before skull-pin insertion
Procedure: Scalp Nerve Blocks With Saline



Primary Outcome Measures :
  1. serum TNF-α level [ Time Frame: 24 hour after surgery ]
  2. serum IL-6 level [ Time Frame: 24 hour after surgery ]
  3. serum IL-1β level [ Time Frame: 24 hour after surgery ]

Secondary Outcome Measures :
  1. serum TNF-α level [ Time Frame: 1 hour after surgery ]
  2. serum IL-6 level [ Time Frame: 1 hour after surgery ]
  3. serum IL-1β level [ Time Frame: 1 hour after surgery ]
  4. serum TNF-α level [ Time Frame: 72 hour after surgery ]
  5. serum IL-6 level [ Time Frame: 72 hour after surgery ]
  6. serum IL-1β level [ Time Frame: 72 hour after surgery ]
  7. VAS score [ Time Frame: 24 hour after surgery ]
  8. VAS score [ Time Frame: 48 hour after surgery ]
  9. VAS score [ Time Frame: 72 hour after surgery ]
  10. dosage of pain-control medicine [ Time Frame: within 72 hour after surgery ]
  11. NRS score [ Time Frame: 24 hour after surgery ]
  12. NRS score [ Time Frame: 48 hour after surgery ]
  13. NRS score [ Time Frame: 72 hour after surgery ]
  14. incidence of intracranial infection [ Time Frame: within 30 days after surgery ]
  15. Hospitalization Days [ Time Frame: up to 30 days ]
  16. out of pocket expenditure for hospitalisation [ Time Frame: hospital discharge/up to 30 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI 18-28 kg/m2 ASA Physical Status 1-2 diagnosed Meningeoma and will have selective Meningeoma Resection Surgery the incision will be conducted at the frontal, top or the temperal skull.

Exclusion Criteria:

  • 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

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): NCT02939833


Locations
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China, Shanghai
Shanghai Renji hospital
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
RenJi Hospital

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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT02939833     History of Changes
Other Study ID Numbers: NB20161010
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: October 20, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Inflammation
Meningioma
Pathologic Processes
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