MeningiomasNCT02939833
Effects of Scalp Nerve Blocks on Systemic Inflammation
A study testing Scalp Nerve Blocks With Ropivacaine and Scalp Nerve Blocks With Saline in people with Meningiomas, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Meningiomas
- What is being tested?
- Scalp Nerve Blocks With Ropivacaine and Scalp Nerve Blocks With Saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Scalp Nerve Blocks on Systemic Inflammation After Meningeoma Resection Surgery：a Prospective Randomized Controlled Trial
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.
- Conditions
- Meningiomas
- Being tested
- Scalp Nerve Blocks With Ropivacaine, Scalp Nerve Blocks With Saline
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp Nerve Blocks With RopivacaineProcedure or surgery
Scalp Nerve Blocks With SalineProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine | Experimental | patients in this group will receive scalp nerve blocks with 0.5% ropivacaine after anesthesia induction and before skull-pin insertion Receives: Procedure: Scalp Nerve Blocks With Ropivacaine |
| saline | Placebo comparator | patients in this group will receive scalp nerve blocks with 0.9% saline after anesthesia induction and before skull-pin insertion Receives: Procedure: Scalp Nerve Blocks With Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum TNF-α level
Measured: 24 hour after surgery
serum IL-6 level
Measured: 24 hour after surgery
serum IL-1β level
Measured: 24 hour after surgery
Secondary outcomes (16)
serum TNF-α level
Measured: 1 hour after surgery
serum IL-6 level
Measured: 1 hour after surgery
serum IL-1β level
Measured: 1 hour after surgery
serum TNF-α level
Measured: 72 hour after surgery
serum IL-6 level
Measured: 72 hour after surgery
serum IL-1β level
Measured: 72 hour after surgery
VAS score
Measured: 24 hour after surgery
VAS score
Measured: 48 hour after surgery
VAS score
Measured: 72 hour after surgery
dosage of pain-control medicine
Measured: within 72 hour after surgery
NRS score
Measured: 24 hour after surgery
NRS score
Measured: 48 hour after surgery
NRS score
Measured: 72 hour after surgery
incidence of intracranial infection
Measured: within 30 days after surgery
Hospitalization Days
Measured: up to 30 days
out of pocket expenditure for hospitalisation
Measured: hospital discharge/up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomasStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939833
- Sponsor's protocol ID
- NB20161010
- Status last verified
- Oct 2016
- First submitted
- 11 Oct 2016
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Scalp Nerve Blocks on Systemic Inflammation After Meningeoma Resection Surgery：a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02939833
- Acronym / sponsor ID
- NB20161010
- Conditions
- Meningiomas
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ropivacaine | Experimental | Procedure: Scalp Nerve Blocks With Ropivacainepatients in this group will receive scalp nerve blocks with 0.5% ropivacaine after anesthesia induction and before skull-pin insertion |
| saline | Placebo comparator | Procedure: Scalp Nerve Blocks With Salinepatients in this group will receive scalp nerve blocks with 0.9% saline after anesthesia induction and before skull-pin insertion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scalp Nerve Blocks With Ropivacaine | Procedure or surgery | ropivacaine |
| Scalp Nerve Blocks With Saline | Procedure or surgery | saline |
Primary outcome
serum TNF-α level
Time frame: 24 hour after surgery
serum IL-6 level
Time frame: 24 hour after surgery
serum IL-1β level
Time frame: 24 hour after surgery
16 secondary outcomes
serum TNF-α level
Time frame: 1 hour after surgery
serum IL-6 level
Time frame: 1 hour after surgery
serum IL-1β level
Time frame: 1 hour after surgery
serum TNF-α level
Time frame: 72 hour after surgery
serum IL-6 level
Time frame: 72 hour after surgery
serum IL-1β level
Time frame: 72 hour after surgery
VAS score
Time frame: 24 hour after surgery
VAS score
Time frame: 48 hour after surgery
VAS score
Time frame: 72 hour after surgery
dosage of pain-control medicine
Time frame: within 72 hour after surgery
NRS score
Time frame: 24 hour after surgery
NRS score
Time frame: 48 hour after surgery
NRS score
Time frame: 72 hour after surgery
incidence of intracranial infection
Time frame: within 30 days after surgery
Hospitalization Days
Time frame: up to 30 days
out of pocket expenditure for hospitalisation
Time frame: hospital discharge/up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Meningiomas
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
RecruitingPhase 2
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas
Intracranial Meningioma, Recurrent Meningioma
Active, not recruitingPhase 1
Combination of Alpelisib and Trametinib in Progressive Refractory Meningiomas
Meningioma
RecruitingPhase 4
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
CNS Tumors, Meningioma
RecruitingPhase 2
A Study of JZP3507 (ONC206) in Recurrent Grade 2 or 3 Meningioma
Meningioma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scalp Nerve Blocks With Ropivacaine and Scalp Nerve Blocks With Saline in people with Meningiomas, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum TNF-α level (time frame: 24 hour after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2016.