Postoperative Analgesia in Patients With Microvascular Decompression

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

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.

Study Overview

• Status: Unknown
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Other: scalp nerve block; Drug: ondansetron; Drug: Sufentanil; Drug: Ketamine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A; Patients in Group A will receive scalp nerve block and patient-controlled analgesia which contains sufentanil and ondansetron.	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.; Drug: Sufentanil; Sufentanil(0.02ug/kg/h) is applied in patient-controlled analgesia.
EXPERIMENTAL: Group B; In Group B, patient-controlled analgesia which contains sufentanil、ondansetron and ketamine will be applied.	Drug: ondansetron; Ondansetron(13ug/kg/h) is applied in patient-controlled analgesia.; Drug: Sufentanil; Sufentanil(0.02ug/kg/h) is applied in patient-controlled analgesia.; Drug: Ketamine; Ketamine will be applied in patient-controlled analgesia.
SHAM_COMPARATOR: Group C; In Group C, patient-controlled analgesia which contains sufentanil and ondansetron will be applied.	Drug: ondansetron; Ondansetron(13ug/kg/h) is applied in patient-controlled analgesia.; Drug: Sufentanil; Sufentanil(0.02ug/kg/h) is applied in patient-controlled analgesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
visual analog scale score	6 hour after operation

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University
• Investigators: Study Director: Xie Yongqiu, Xiangya Hospital of Central South University in Changsha

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2017
• Primary Completion (ANTICIPATED): May 15, 2018
• Study Completion (ANTICIPATED): May 15, 2018

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: May 12, 2017
• First Posted (ACTUAL): May 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 15, 2018
• Last Update Submitted That Met QC Criteria: May 14, 2018
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: nerve block; trigeminal neuralgia
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Trigeminal Neuralgia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Analgesics, Opioid; Narcotics; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Adjuvants, Anesthesia; Anti-Anxiety Agents; Antipruritics; Ketamine; Ondansetron; Sufentanil
• Other Study ID Numbers: XiangyaHospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No