Postoperative Analgesia in Patients With Microvascular Decompression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Multimodal Analgesia Used in Patients With Microvascular Decompression

Conditions
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Trigeminal Neuralgia

Intervention / Treatment
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* Drug: Ketamine
* Other: scalp nerve block
* Drug: ondansetron
* Drug: Sufentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: More than 20% of the total blood volume is lost in operation Intracranial hematoma happens within 24 h after surgery Secondary surgery patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Patients in Group A will receive scalp nerve block and patient-controlled analgesia which contains sufentanil and ondansetron. | Other: scalp nerve block<br>* Scalp nerve block is performed for the blockade of the greater occipital, superficial cervical and lesser occipital nerves with 0.5% ropivacaine.<br>Drug: ondansetron<br>* Ondansetron(13ug/kg/h) is applied in patient-controlled analgesia.<br>Drug: Sufentanil<br>* Sufentanil(0.02ug/kg/h) is applied in patient-controlled analgesia.<br>|
| Experimental: Group B<br>In Group B, patient-controlled analgesia which contains sufentanil、ondansetron and ketamine will be applied. | Drug: Ketamine<br>* Ketamine will be applied in patient-controlled analgesia.<br>Drug: ondansetron<br>* Ondansetron(13ug/kg/h) is applied in patient-controlled analgesia.<br>Drug: Sufentanil<br>* Sufentanil(0.02ug/kg/h) is applied in patient-controlled analgesia.<br>|
| Sham Comparator: Group C<br>In Group C, patient-controlled analgesia which contains sufentanil and ondansetron will be applied. | Drug: ondansetron<br>* Ondansetron(13ug/kg/h) is applied in patient-controlled analgesia.<br>Drug: Sufentanil<br>* Sufentanil(0.02ug/kg/h) is applied in patient-controlled analgesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale score |  | 6 hour after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trigeminal neuralgia, nerve block