Postoperative Analgesia in Patients With Microvascular Decompression

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03152955
• Other study ID #: XiangyaHospital
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 15, 2017
• Est. completion date: May 15, 2018

Study information

• Verified date: May 2017
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: May 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients of trigeminal neuralgia plan to receive microvascular decompression

2. Age between 18 and 70, ASA classification between ?~?

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

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Drug:
• Ketamine
Ketamine will be applied in patient-controlled analgesia.

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

Locations

Country	Name	City	State
China	Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analog scale score		6 hour after operation