Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery

Cervical Spine Degeneration Clinical Trial

Official title:

Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03955705
• Other study ID #: Si204/2019
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2020
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: May 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Spine Degeneration

Intervention

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.
• Normal saline
0.9% Sodium chloride (normal saline or NSS)

Locations

Country	Name	City	State
Thailand	Siriraj Hospital Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

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. — View 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. Review. — View 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. Revie — View 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. Review. — View Citation

Sunshine A, Laska E. Nefopam and morphine in man. Clin Pharmacol Ther. 1975 Nov;18(5 Pt 1):530-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption	Intravenous morphine was given to all by patient controlled analgesia (PCA) machine. The higher morphine consumption reflects higher postoperative pain.	24 hours
Secondary	The change in Thai version of the Neuropathic Pain Symptom Inventory (NPSI-T score)	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	30 days
Secondary	The change in pain scores	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.	72 hours