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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03955705
Other study ID # Si204/2019
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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Withdrawn NCT03312192 - Stand-Alone Cage Verus Anterior Plating for Anterior Cervical Discectomy and Fusion. N/A
Recruiting NCT06202443 - Improving Surgical Outcomes With Early PT After ACDF N/A
Completed NCT06428981 - Surgical Intervention on the Body-mind-spirit of Patients With Cervical Spine Surgery N/A