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Clinical Trials/NCT03152955
NCT03152955
Unknown
Phase 4

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

Xiangya Hospital of Central South University1 site in 1 country90 target enrollmentMay 15, 2017

Overview

Phase
Phase 4
Intervention
scalp nerve block
Conditions
Trigeminal Neuralgia
Sponsor
Xiangya Hospital of Central South University
Enrollment
90
Locations
1
Primary Endpoint
visual analog scale score
Last Updated
7 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 15, 2017
End Date
May 15, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Xiangya Hospital of Central South University
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Group A

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

Intervention: scalp nerve block

Group A

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

Intervention: ondansetron

Group A

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

Intervention: Sufentanil

Group B

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

Intervention: Ketamine

Group B

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

Intervention: ondansetron

Group B

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

Intervention: Sufentanil

Group C

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

Intervention: ondansetron

Group C

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

Intervention: Sufentanil

Outcomes

Primary Outcomes

visual analog scale score

Time Frame: 6 hour after operation

Study Sites (1)

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