Postoperative Analgesia in Patients With Microvascular Decompression

NCT03152955 | Unknown Phase 4

• 1 other identifier: XiangyaHospital
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigeminal Neuralgia

Keywords

trigeminal neuralgia; nerve block

Outcome Measures

Primary Outcomes (1)

• visual analog scale score

  6 hour after operation

Study Arms (3)

Group A

EXPERIMENTAL

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

Other: scalp nerve block; Drug: ondansetron; Drug: Sufentanil

Group B

EXPERIMENTAL

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

Drug: Ketamine; Drug: ondansetron; Drug: Sufentanil

Group C

SHAM COMPARATOR

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

Drug: ondansetron; Drug: Sufentanil

Interventions

Ketamine DRUG

Ketamine will be applied in patient-controlled analgesia.

Group B

scalp nerve block OTHER

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

Group A

ondansetron DRUG

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

Group A; Group B; Group C

Sufentanil DRUG

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

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Ketamine; Ondansetron; Sufentanil

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Fentanyl; Piperidines

Study Officials

• Xie Yongqiu

  Xiangya Hospital of Central South University in Changsha

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 15, 2017
• Study Start: May 15, 2017
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: May 15, 2018

Record last verified: 2017-05

Locations

CN (1)