Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery

• Sponsor: Mahidol University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT03955705
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24.5
• Patients Per Site Per Month: 2

Study Details

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	N/A

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

• Study Type: Interventional
• Anticipated 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
• Anticipated Primary Completion Date: Apr 30, 2021
• Anticipated 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 Names: 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 Names: 0.9% NaCl or NSS

Outcome Measures

Primary Outcome Measures

1. Total morphine consumption [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) [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

	Site	City	State	Country	Postal Code
1	Siriraj Hospital Mahidol University	Bangkok		Thailand	10700

Sponsors and Collaborators

• Mahidol University

Investigators

• Principal Investigator: Manee Raksakietisak, MD, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Mahidol University
• ClinicalTrials.gov Identifier: NCT03955705
• Other Study ID Numbers: Si204/2019
• First Posted: May 20, 2019
• Last Update Posted: Sep 4, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nefopam

Study Results

No Results Posted as of Sep 4, 2020