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Postoperative Analgesia in Patients With Microvascular Decompression

Primary Purpose

Trigeminal Neuralgia

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Ketamine

scalp nerve block

ondansetron

Sufentanil

About this trial

This is an interventional treatment trial for Trigeminal Neuralgia focused on measuring trigeminal neuralgia, nerve block

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Xiangya Hospital of Central South University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Arm Label

Group A

Group B

Group C

Arm Description

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.

Outcomes

Primary Outcome Measures

visual analog scale score

Secondary Outcome Measures

Full Information

NCT ID

NCT03152955

First Posted

May 4, 2017

Last Updated

May 14, 2018

Sponsor

Xiangya Hospital of Central South University

1. Study Identification

Unique Protocol Identification Number

NCT03152955

Brief Title

Postoperative Analgesia in Patients With Microvascular Decompression

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

May 15, 2017 (Actual)

Primary Completion Date

May 15, 2018 (Anticipated)

Study Completion Date

May 15, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trigeminal Neuralgia

Keywords

trigeminal neuralgia, nerve block

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

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

Arm Title

Group B

Arm Type

Experimental

Arm Description

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

Arm Title

Group C

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Description

Ketamine will be applied in patient-controlled analgesia.

Intervention Type

Other

Intervention Name(s)

scalp nerve block

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

ondansetron

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sufentanil

Intervention Description

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

Primary Outcome Measure Information:

Title

visual analog scale score

Time Frame

6 hour after operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xie Yongqiu

Organizational Affiliation

Xiangya Hospital of Central South University in Changsha

Official's Role

Study Director

Facility Information:

Facility Name

Xiangya Hospital of Central South University

City

Changsha

State/Province

Hunan

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Postoperative Analgesia in Patients With Microvascular Decompression

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