Clinical trial NCT03955705: Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery
Official title: Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Spine Degeneration
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Total morphine consumption
timeFrame: 24 hours
Secondary outcomes:
measure: The change in Thai version of the Neuropathic Pain Symptom Inventory (NPSI-T score)
timeFrame: 30 days
measure: The change in pain scores
timeFrame: 72 hours
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital Mahidol University
Study officials:
affiliation: Mahidol University
name: Manee Raksakietisak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.2106/00004623-200210000-00021. No abstract available.
citation: 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. doi: 10.1111/j.1365-2044.1994.tb04352.x.
citation: Sunshine A, Laska E. Nefopam and morphine in man. Clin Pharmacol Ther. 1975 Nov;18(5 Pt 1):530-4. doi: 10.1002/cpt1975185part1530.
citation: 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.
citation: 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.