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Trial record 3 of 6 for:    "Trigeminal Nerve Disease" | "Analgesics"

Postoperative Analgesia in Patients With Microvascular Decompression

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ClinicalTrials.gov Identifier: NCT03152955
Recruitment Status : Unknown
Verified May 2017 by Xiangya Hospital of Central South University.
Recruitment status was:  Active, not recruiting
First Posted : May 15, 2017
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Trigeminal Neuralgia Drug: Ketamine Other: scalp nerve block Drug: ondansetron Drug: Sufentanil Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Multimodal Analgesia Used in Patients With Microvascular Decompression
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : May 15, 2018
Estimated Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
Patients in Group A will receive scalp nerve block and patient-controlled analgesia which contains sufentanil and ondansetron.
Other: scalp nerve block
Scalp nerve block is performed for the blockade of the greater occipital, superficial cervical and lesser occipital nerves with 0.5% ropivacaine.

Drug: ondansetron
Ondansetron(13ug/kg/h) is applied in patient-controlled analgesia.

Drug: Sufentanil
Sufentanil(0.02ug/kg/h) is applied in patient-controlled analgesia.

Experimental: Group B
In Group B, patient-controlled analgesia which contains sufentanil、ondansetron and ketamine will be applied.
Drug: Ketamine
Ketamine will be applied in patient-controlled analgesia.

Drug: ondansetron
Ondansetron(13ug/kg/h) is applied in patient-controlled analgesia.

Drug: Sufentanil
Sufentanil(0.02ug/kg/h) is applied in patient-controlled analgesia.

Sham Comparator: Group C
In Group C, patient-controlled analgesia which contains sufentanil and ondansetron will be applied.
Drug: ondansetron
Ondansetron(13ug/kg/h) is applied in patient-controlled analgesia.

Drug: Sufentanil
Sufentanil(0.02ug/kg/h) is applied in patient-controlled analgesia.




Primary Outcome Measures :
  1. visual analog scale score [ Time Frame: 6 hour after operation ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients of trigeminal neuralgia plan to receive microvascular decompression
  2. Age between 18 and 70, ASA classification between Ⅰ~Ⅲ
  3. No severe liver and kidney disease, no blood coagulation dysfunction
  4. No history of long-term opioid drugs usage, no drug addiction history
  5. Patients are fully conscious, cooperation, understanding and voluntarily signed informed consent

Exclusion Criteria:

  1. More than 20% of the total blood volume is lost in operation
  2. Intracranial hematoma happens within 24 h after surgery
  3. Secondary surgery patients

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): NCT03152955


Locations
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China, Hunan
Xiangya Hospital of Central South University
Changsha, Hunan, China
Sponsors and Collaborators
Xiangya Hospital of Central South University
Investigators
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Study Director: Xie Yongqiu Xiangya Hospital of Central South University in Changsha

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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03152955     History of Changes
Other Study ID Numbers: XiangyaHospital
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiangya Hospital of Central South University:
trigeminal neuralgia
nerve block
Additional relevant MeSH terms:
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Trigeminal Nerve Diseases
Analgesics
Analgesics, Opioid
Trigeminal Neuralgia
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases
Sufentanil
Ketamine
Ondansetron
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents