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出境医 / 临床实验 / Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery

Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery

Study Description
Brief Summary:
Nefopam is a benzoxazocine derivative which is non-opioid and non NSAIDs. The previous studies showed that nefopam can inhibit reuptake of serotonin, norepinephrine and dopamine. It has no respiratory depression so may be useful in potential airway compromized surgery like anterior cervical discectomy and fusion (ACDF). This study aims to study the analgesic properties of nefopam after ACDF.

Condition or disease Intervention/treatment Phase
Cervical Spine Degeneration Drug: Nefopam 20 mg/ml Drug: Normal saline Not Applicable

Detailed Description:
The investigators enroll 50 patient who admitted for ACDF. Standard general anesthesia will be performed in all of the patients. Then, an hour before finishing operation, the patients will be divided into two groups. The first group will receive Nefopam 20 mg infuse for 60 min. The another group or group NSS will receive the same amount of 0.9% sodium chloride. The recorded data include patient demographic data, intraoperative blood loss, hemodynamics and pre and postoperative pain scores and Thai version of the Neuropathic Pain Symptom Inventory (NPSI-T score).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : May 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Nefopam
Nefopam: 20 mg (infuse at least 15 minutes) every 4-6 hours, max 120 mg/day
 Drug: Nefopam 20 mg/ml
Nefopam is a benzoxazocine derivative which is non-opioid and non NSAIDs. The previous studies showed that nefopam can inhibit reuptake of serotonin, norepinephrine and dopamine.
Other Name: Acupan
Placebo Comparator: Normal saline solution
Normal saline or 0.9% Sodium Chloride (NaCl) or NSS
 Drug: Normal saline
0.9% Sodium chloride (normal saline or NSS)
Other Name: 0.9% NaCl or NSS
Outcome Measures
Primary Outcome Measures :
  1. Total morphine consumption [ Time Frame: 24 hours ]
    Intravenous morphine was given to all by patient controlled analgesia (PCA) machine. The higher morphine consumption reflects higher postoperative pain.


Secondary Outcome Measures :
  1. The change in Thai version of the Neuropathic Pain Symptom Inventory (NPSI-T score) [ Time Frame: 30 days ]
    Changes in NPSI-T (minimum 0- maximum 100) period by recording NPSI-T at preoperative period, compared with postoperative day 1, 3, 15,30. The total score is 100, the higher scores reflect higher neuropathic pain

  2. The change in pain scores [ Time Frame: 72 hours ]
    Changes in pain scores (minimum 0- maximum 10) at different time point 0 (upon arrival to recovery room), postoperative at 4, 8, 12, 16, 24, 48, 72 hours. The higher scores reflect higher pain.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with cervical spondylosis or cervical spondylotic myelopathy undergoing elective anterior cervical spine surgery such as ACDF or anterior cervical corpectomy and fusion (ACCF)
  • American Society of Anesthesiologists (ASA) class I-III
  • Age 18-75 years old
  • Body weight > 50 kg, BMI < 30 kg/m2

Exclusion Criteria:

  • Convulsion or seizure
  • Myocardial ischemia or infarction
  • Risk of urinary retention from urethral disease or prostate disease
  • Angle closure glaucoma
  • Patients on monoamine oxidase inhibitor
  • Psychiatric patients
  • Pregnant or lactated woman
  • Creatinine clearance < 30 ml/min
  • Allergic to nefopam
  • Patients on pregabaline or gabapentin
  • Poorly controlled hypertension
  • Cannot understand or do the questionnaire of Thai version of Neuropathic pain symptom inventory (NPSI-T) score
Contacts and Locations

Locations
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Thailand
Siriraj Hospital Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Manee Raksakietisak, MD Mahidol University
Tracking Information
First Submitted Date  ICMJE May 7, 2019
First Posted Date  ICMJE May 20, 2019
Last Update Posted Date September 4, 2020
Actual Study Start Date  ICMJE May 15, 2019
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2019) 		Total morphine consumption [ Time Frame: 24 hours ]
Intravenous morphine was given to all by patient controlled analgesia (PCA) machine. The higher morphine consumption reflects higher postoperative pain.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2019)
  • The change in Thai version of the Neuropathic Pain Symptom Inventory (NPSI-T score) [ Time Frame: 30 days ]
    Changes in NPSI-T (minimum 0- maximum 100) period by recording NPSI-T at preoperative period, compared with postoperative day 1, 3, 15,30. The total score is 100, the higher scores reflect higher neuropathic pain
  • The change in pain scores [ Time Frame: 72 hours ]
    Changes in pain scores (minimum 0- maximum 10) at different time point 0 (upon arrival to recovery room), postoperative at 4, 8, 12, 16, 24, 48, 72 hours. The higher scores reflect higher pain.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery
Official Title  ICMJE Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery
Brief Summary Nefopam is a benzoxazocine derivative which is non-opioid and non NSAIDs. The previous studies showed that nefopam can inhibit reuptake of serotonin, norepinephrine and dopamine. It has no respiratory depression so may be useful in potential airway compromized surgery like anterior cervical discectomy and fusion (ACDF). This study aims to study the analgesic properties of nefopam after ACDF.
Detailed Description The investigators enroll 50 patient who admitted for ACDF. Standard general anesthesia will be performed in all of the patients. Then, an hour before finishing operation, the patients will be divided into two groups. The first group will receive Nefopam 20 mg infuse for 60 min. The another group or group NSS will receive the same amount of 0.9% sodium chloride. The recorded data include patient demographic data, intraoperative blood loss, hemodynamics and pre and postoperative pain scores and Thai version of the Neuropathic Pain Symptom Inventory (NPSI-T score).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cervical Spine Degeneration
Intervention  ICMJE
  • Drug: Nefopam 20 mg/ml
    Nefopam is a benzoxazocine derivative which is non-opioid and non NSAIDs. The previous studies showed that nefopam can inhibit reuptake of serotonin, norepinephrine and dopamine.
    Other Name: Acupan
  • Drug: Normal saline
    0.9% Sodium chloride (normal saline or NSS)
    Other Name: 0.9% NaCl or NSS
Study Arms  ICMJE
  • Experimental: Nefopam
    Nefopam: 20 mg (infuse at least 15 minutes) every 4-6 hours, max 120 mg/day
    Intervention: Drug: Nefopam 20 mg/ml
  • Placebo Comparator: Normal saline solution
    Normal saline or 0.9% Sodium Chloride (NaCl) or NSS
    Intervention: Drug: Normal saline
Publications *
  • Rao R. Neck pain, cervical radiculopathy, and cervical myelopathy: pathophysiology, natural history, and clinical evaluation. J Bone Joint Surg Am. 2002 Oct;84(10):1872-81. Review.
  • Dordoni PL, Della Ventura M, Stefanelli A, Iannace E, Paparella P, Rocca B, Accorra F. Effect of ketorolac, ketoprofen and nefopam on platelet function. Anaesthesia. 1994 Dec;49(12):1046-9.
  • Sunshine A, Laska E. Nefopam and morphine in man. Clin Pharmacol Ther. 1975 Nov;18(5 Pt 1):530-4.
  • Kim KH, Abdi S. Rediscovery of nefopam for the treatment of neuropathic pain. Korean J Pain. 2014 Apr;27(2):103-11. doi: 10.3344/kjp.2014.27.2.103. Epub 2014 Mar 28. Review.
  • Martinez V, Beloeil H, Marret E, Fletcher D, Ravaud P, Trinquart L. Non-opioid analgesics in adults after major surgery: systematic review with network meta-analysis of randomized trials. Br J Anaesth. 2017 Jan;118(1):22-31. doi: 10.1093/bja/aew391. Review.

*   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 Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 17, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with cervical spondylosis or cervical spondylotic myelopathy undergoing elective anterior cervical spine surgery such as ACDF or anterior cervical corpectomy and fusion (ACCF)
  • American Society of Anesthesiologists (ASA) class I-III
  • Age 18-75 years old
  • Body weight > 50 kg, BMI < 30 kg/m2

Exclusion Criteria:

  • Convulsion or seizure
  • Myocardial ischemia or infarction
  • Risk of urinary retention from urethral disease or prostate disease
  • Angle closure glaucoma
  • Patients on monoamine oxidase inhibitor
  • Psychiatric patients
  • Pregnant or lactated woman
  • Creatinine clearance < 30 ml/min
  • Allergic to nefopam
  • Patients on pregabaline or gabapentin
  • Poorly controlled hypertension
  • Cannot understand or do the questionnaire of Thai version of Neuropathic pain symptom inventory (NPSI-T) score
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 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 Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03955705
Other Study ID Numbers  ICMJE Si204/2019
Has Data Monitoring Committee No
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: No
Responsible Party Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Manee Raksakietisak, MD Mahidol University
PRS Account Mahidol University
Verification Date September 2020

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

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