Postoperative Analgesia in Patients With Microvascular Decompression

NCT ID: NCT03152955

Last Updated: 2018-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2018-05-15

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.

Conditions

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Trigeminal Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

Patients in Group A will receive scalp nerve block and patient-controlled analgesia which contains sufentanil and ondansetron.

Group Type EXPERIMENTAL

scalp nerve block

Intervention Type OTHER

Scalp nerve block is performed for the blockade of the greater occipital, superficial cervical and lesser occipital nerves with 0.5% ropivacaine.

ondansetron

Intervention Type DRUG

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

Sufentanil

Intervention Type DRUG

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

Group B

In Group B, patient-controlled analgesia which contains sufentanil、ondansetron and ketamine will be applied.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Ketamine will be applied in patient-controlled analgesia.

ondansetron

Intervention Type DRUG

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

Sufentanil

Intervention Type DRUG

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

Group C

In Group C, patient-controlled analgesia which contains sufentanil and ondansetron will be applied.

Group Type SHAM_COMPARATOR

ondansetron

Intervention Type DRUG

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

Sufentanil

Intervention Type DRUG

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

Interventions

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Ketamine

Ketamine will be applied in patient-controlled analgesia.

Intervention Type DRUG

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.

Intervention Type OTHER

ondansetron

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

Intervention Type DRUG

Sufentanil

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xie Yongqiu

Role: STUDY_DIRECTOR

Xiangya Hospital of Central South University in Changsha

Locations

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Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

Countries

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China

Other Identifiers

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XiangyaHospital

Identifier Type: -

Identifier Source: org_study_id

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