Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Postoperative Analgesia in Patients With Microvascular Decompression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03152955
Recruitment Status : Unknown
Verified May 2017 by Xiangya Hospital of Central South University.
Recruitment status was:  Active, not recruiting
First Posted : May 15, 2017
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

Tracking Information
First Submitted Date  ICMJE May 4, 2017
First Posted Date  ICMJE May 15, 2017
Last Update Posted Date May 15, 2018
Actual Study Start Date  ICMJE May 15, 2017
Estimated Primary Completion Date May 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2017)
visual analog scale score [ Time Frame: 6 hour after operation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postoperative Analgesia in Patients With Microvascular Decompression
Official Title  ICMJE Efficacy and Safety of Multimodal Analgesia Used in Patients With Microvascular Decompression
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Trigeminal Neuralgia
Intervention  ICMJE
  • 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.
  • Drug: Sufentanil
    Sufentanil(0.02ug/kg/h) is applied in patient-controlled analgesia.
Study Arms  ICMJE
  • Experimental: Group A
    Patients in Group A will receive scalp nerve block and patient-controlled analgesia which contains sufentanil and ondansetron.
    Interventions:
    • Other: scalp nerve block
    • Drug: ondansetron
    • Drug: Sufentanil
  • Experimental: Group B
    In Group B, patient-controlled analgesia which contains sufentanil、ondansetron and ketamine will be applied.
    Interventions:
    • Drug: Ketamine
    • Drug: ondansetron
    • Drug: Sufentanil
  • Sham Comparator: Group C
    In Group C, patient-controlled analgesia which contains sufentanil and ondansetron will be applied.
    Interventions:
    • Drug: ondansetron
    • Drug: Sufentanil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 12, 2017)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 15, 2018
Estimated Primary Completion Date May 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03152955
Other Study ID Numbers  ICMJE XiangyaHospital
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Xiangya Hospital of Central South University
Study Sponsor  ICMJE Xiangya Hospital of Central South University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Xie Yongqiu Xiangya Hospital of Central South University in Changsha
PRS Account Xiangya Hospital of Central South University
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP