Trigeminal NeuralgiaPhase 4NCT03152955
Postoperative Analgesia in Patients With Microvascular Decompression
A Phase 4 study testing Ketamine, scalp nerve block and ondansetron in people with Trigeminal Neuralgia, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Perioperative pain is caused by a variety of harmful factors through multiple mechanisms, therefore, reasonable postoperative analgesia should be combined with drugs or measures of different mechanism , which is called multimodal analgesia. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Ketamine, scalp nerve block and ondansetron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2017to 15 May 2018
- Phase
- Phase 4
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of trigeminal neuralgia plan to receive microvascular decompression
- Age between 18 and 70, ASA classification between Ⅰ～Ⅲ
- No severe liver and kidney disease, no blood coagulation dysfunction
- No history of long-term opioid drugs usage, no drug addiction history
- Patients are fully conscious, cooperation, understanding and voluntarily signed informed consent
Who cannot join
- More than 20% of the total blood volume is lost in operation
- Intracranial hematoma happens within 24 h after surgery
- Secondary surgery patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Multimodal Analgesia Used in Patients With Microvascular Decompression
Perioperative pain is caused by a variety of harmful factors through multiple mechanisms, therefore, reasonable postoperative analgesia should be combined with drugs or measures of different mechanism , which is called multimodal analgesia. Multimodal analgesia could minimize side effects and achieve a better analgesic effect. Commonly used strategies of multimodal analgesia are oral analgesic drug, nerve block, patient controlled analgesia and so on. This study will observe the effect of multimodal analgesia on postoperative pain in patients with microvascular decompression and record side effects. Finally, it will provide technical support for the guidance of postoperative analgesia in patients of trigeminal neuralgia.
Read the detailed description
The investigators will collect 90 cases which will be divided into 3 groups. Patients in Group A will receive scalp nerve block and patient-controlled analgesia which contains sufentanil and ondansetron. In Group B, patient-controlled analgesia which contains sufentanil, ondansetron and ketamine will be applied. In Group C, patient-controlled analgesia which contains sufentanil and ondansetron will be applied.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Ketamine, scalp nerve block, ondansetron, Sufentanil
- Keywords
- trigeminal neuralgia, nerve block
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Ketamine will be applied in patient-controlled analgesia.
scalp nerve blockOther
Scalp nerve block is performed for the blockade of the greater occipital, superficial cervical and lesser occipital nerves with 0.5% ropivacaine.
ondansetronDrug
Ondansetron(13ug/kg/h) is applied in patient-controlled analgesia.
SufentanilDrug
Sufentanil(0.02ug/kg/h) is applied in patient-controlled analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients in Group A will receive scalp nerve block and patient-controlled analgesia which contains sufentanil and ondansetron. Receives: Other: scalp nerve block; Drug: ondansetron; Drug: Sufentanil |
| Group B | Experimental | In Group B, patient-controlled analgesia which contains sufentanil、ondansetron and ketamine will be applied. Receives: Drug: Ketamine; Drug: ondansetron; Drug: Sufentanil |
| Group C | Sham comparator | In Group C, patient-controlled analgesia which contains sufentanil and ondansetron will be applied. Receives: Drug: ondansetron; Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale score
Measured: 6 hour after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start15 May 2017
- Primary completion15 May 2018 (estimated)
- Study completion15 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xie Yongqiu, Study director, Xiangya Hospital of Central South University in Changsha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152955
- Sponsor's protocol ID
- XiangyaHospital
- Status last verified
- May 2017
- First submitted
- 4 May 2017
- Last updated
- 15 May 2018
- Results posted
- 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 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Multimodal Analgesia Used in Patients With Microvascular Decompression
- ClinicalTrials.gov ID
- NCT03152955
- Acronym / sponsor ID
- XiangyaHospital
- Conditions
- Trigeminal Neuralgia
- Keywords
- trigeminal neuralgia, nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 15 May 2018 (estimated)
- Study completion
- 15 May 2018 (estimated)
- First posted
- 15 May 2017 (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.
Perioperative pain is caused by a variety of harmful factors through multiple mechanisms, therefore, reasonable postoperative analgesia should be combined with drugs or measures of different mechanism , which is called multimodal analgesia. Multimodal analgesia could minimize side effects and achieve a better analgesic effect. Commonly used strategies of multimodal analgesia are oral analgesic drug, nerve block, patient controlled analgesia and so on. This study will observe the effect of multimodal analgesia on postoperative pain in patients with microvascular decompression and record side effects. Finally, it will provide technical support for the guidance of postoperative analgesia in patients of trigeminal neuralgia.
Detailed description
The investigators will collect 90 cases which will be divided into 3 groups. Patients in Group A will receive scalp nerve block and patient-controlled analgesia which contains sufentanil and ondansetron. In Group B, patient-controlled analgesia which contains sufentanil, ondansetron and ketamine will be applied. In Group C, patient-controlled analgesia which contains sufentanil and ondansetron will be applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: scalp nerve block, Drug: ondansetron, Drug: SufentanilPatients in Group A will receive scalp nerve block and patient-controlled analgesia which contains sufentanil and ondansetron. |
| Group B | Experimental | Drug: Ketamine, Drug: ondansetron, Drug: SufentanilIn Group B, patient-controlled analgesia which contains sufentanil、ondansetron and ketamine will be applied. |
| Group C | Sham comparator | Drug: ondansetron, Drug: SufentanilIn Group C, patient-controlled analgesia which contains sufentanil and ondansetron will be applied. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of trigeminal neuralgia plan to receive microvascular decompression
- Age between 18 and 70, ASA classification between Ⅰ～Ⅲ
- No severe liver and kidney disease, no blood coagulation dysfunction
- No history of long-term opioid drugs usage, no drug addiction history
- Patients are fully conscious, cooperation, understanding and voluntarily signed informed consent
Key exclusion criteria (3 listed)
- More than 20% of the total blood volume is lost in operation
- Intracranial hematoma happens within 24 h after surgery
- Secondary surgery patients
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 |
|---|---|---|
| KetamineKetamine will be applied in patient-controlled analgesia. | Drug | Group B |
| scalp nerve blockScalp nerve block is performed for the blockade of the greater occipital, superficial cervical and lesser occipital nerves with 0.5% ropivacaine. | Other | Group A |
| ondansetronOndansetron(13ug/kg/h) is applied in patient-controlled analgesia. | Drug | Group A, Group B, Group C |
| SufentanilSufentanil(0.02ug/kg/h) is applied in patient-controlled analgesia. | Drug | Group A, Group B, Group C |
Primary outcome
visual analog scale score
Time frame: 6 hour after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- 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.
Xie Yongqiu study director
Xiangya Hospital of Central South University in Changsha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine, scalp nerve block and ondansetron in people with Trigeminal Neuralgia, run by Xiangya Hospital of Central South University 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 5 inclusion and 3 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 15 May 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
visual analog scale score (time frame: 6 hour after operation). 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 15 May 2018.