MeningiomaNCT03648034
Effects of Scalp Nerve Block With Ropivacaine on Postoperative Recovery Quality
A study testing ropivacaine and saline in people with Meningioma, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Meningioma
- What is being tested?
- ropivacaine and saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2018to 30 Nov 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital affliated to Shanghai Jiaotong University School of Medicine
Shanghai, 200127
About this study
Official title: 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.
Read the 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.
- Conditions
- Meningioma
- Being tested
- ropivacaine, saline
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineProcedure or surgery
To perform scalp nerve blocks with ropivacaine
salineProcedure or surgery
To perform scalp nerve blocks with saline
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine | Experimental | After anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.5% ropivacaine Receives: Procedure: ropivacaine |
| saline | Placebo comparator | After anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.9% saline Receives: Procedure: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days post-surgery
Secondary outcomes (12)
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.
Measured: 3 days post-surgery
serum TNF-α levels
an inflammatory mediator that reflects systemic inflammation
Measured: at 1h and 24h post-surgery
serum IL-6 levels
an inflammatory mediator that reflects systemic inflammation
Measured: at 1h and 24h post-surgery
serum IL-1β levels
an inflammatory mediator that reflects systemic inflammation
Measured: 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.
Measured: 1 hour after the surgery is finished
white blood cell
serum white blood cell count
Measured: at 24 h after surgery
serum levels of CRP
inflammatory responses
Measured: 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.
Measured: at 1, 2 and 3 days post-surgery
pain-relief medications
amounts of pain-relief medications
Measured: at 1, 2 and 3 days post-surgery
Hospitalization Days
length of hospitalization
Measured: up to 30 days
out of pocket expenditure for hospitalisation
This reflects how much money the patient spends during hospitalisation
Measured: hospital discharge/up to 30 days
complications
incidence of intracranial infection
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start18 Sep 2018
- Primary completion30 Sep 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Tian, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648034
- Sponsor's protocol ID
- SNB20180813
- Status last verified
- Apr 2020
- First submitted
- 13 Aug 2018
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Scalp Nerve Block on Postoperative Recovery Quality in Patients Undergoing Excision of Intracranial Meningioma
- ClinicalTrials.gov ID
- NCT03648034
- Acronym / sponsor ID
- SNB20180813
- Conditions
- Meningioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 27 Aug 2018 (actual)
- 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ropivacaine | Experimental | Procedure: ropivacaineAfter anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.5% ropivacaine |
| saline | Placebo comparator | Procedure: salineAfter anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.9% saline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| ropivacaineTo perform scalp nerve blocks with ropivacaine | Procedure or surgery | ropivacaine |
| salineTo perform scalp nerve blocks with saline | Procedure or surgery | saline |
Primary outcome
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.
12 secondary outcomes
KPS score
Time frame: 3 days post-surgery
serum TNF-α levels
Time frame: at 1h and 24h post-surgery
serum IL-6 levels
Time frame: at 1h and 24h post-surgery
serum IL-1β levels
Time frame: at 1h and 24h post-surgery
Iowa Satisfaction with Anesthesia Scale (ISAS)
Time frame: 1 hour after the surgery is finished
white blood cell
Time frame: at 24 h after surgery
serum levels of CRP
Time frame: at 24 h after surgery
VAS score
Time frame: at 1, 2 and 3 days post-surgery
pain-relief medications
Time frame: at 1, 2 and 3 days post-surgery
Hospitalization Days
Time frame: up to 30 days
out of pocket expenditure for hospitalisation
Time frame: hospital discharge/up to 30 days
complications
Time frame: within 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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 ropivacaine and saline in people with Meningioma, 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 6 Apr 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
KPS score (time frame: 7 days post-surgery). 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 6 Apr 2020.