Postoperative Analgesia in Patients With Microvascular Decompression

Ketamine

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.

Intervention / Treatment

  • Ketamine (DRUG)
    Ketamine will be applied in patient-controlled analgesia.
  • 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.
  • Ondansetron (DRUG)
    Ondansetron(13ug/kg/h) is applied in patient-controlled analgesia.
  • Sufentanil (DRUG)
    Sufentanil(0.02ug/kg/h) is applied in patient-controlled analgesia.

Condition or Disease

  • Trigeminal Neuralgia

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years to 70 Years
    Enrollment: 90 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: May 15, 2017 ACTUAL
    Primary Completion: May 15, 2018 ESTIMATED
    Completion Date: May 15, 2018 ESTIMATED
    Study First Posted: May 15, 2017 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: May 14, 2018

    Sponsors / Collaborators

    Lead Sponsor: Xiangya Hospital of Central South University
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Hunan, China
    Changsha, Hunan, China

    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.

    Participant 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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 70
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • visual analog scale score 6 hour after operation

    More Details

    NCT Number: NCT03152955
    Other IDs: XiangyaHospital
    Study URL: https://clinicaltrials.gov/study/NCT03152955
    Last updated: Sep 29, 2023