Combination Effect of Nefopam With Propacetamol for Postoperative Pain After Thyroidectomy

Study Overview
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Brief Summary
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Patients undergoing thyroidectomy are suffering not only surgical wound pain but posterior neck pain because of neck extension position during the surgery. However, there has been little attention of posterior neck pain. Nefopam and Propacetamol have different pharmacodynamics and been used for postoperative pain control in thyroidectomy patients. The aim of this study is evaluation of combination effect of Nefopam and Propacetamol for acute wound pain, posterior neck pain and chronic pain after thyroidectomy.

Conditions
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Thyroidectomy, Pain

Intervention / Treatment
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* Drug: Nefopam
* Drug: Propacetamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient who undergone open thyroidectomy 20 70 years old ASA I III Exclusion Criteria: hypersensitivity on Nefopam and Propacetamol Liver failure, chronic alcohol addiction severe hemolytic anemia, chronic nutrition deficiency history of seizure MI, MAO inhibitor pregnant, breast-feeding foreigners

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nefopam group<br> | Drug: Nefopam<br>* Patients undergoing thyroidectomy receive medications depending on the group allocation 30minutes prior to the surgery end; Nefopam 20mg, Propacetamol 2g, and Nefopam 20mg+Propacetamol 2g. In addition, patients will take the same medication every six hours during POD 1.<br>|
| Active Comparator: propacetamol group<br> | Drug: Propacetamol<br>* Patients undergoing thyroidectomy receive medications depending on the group allocation 30minutes prior to the surgery end; Nefopam 20mg, Propacetamol 2g, and Nefopam 20mg+Propacetamol 2g. In addition, patients will take the same medication every six hours during POD 1.<br>|
| Experimental: nefopam and propacetamol group<br> | Drug: Nefopam<br>* Patients undergoing thyroidectomy receive medications depending on the group allocation 30minutes prior to the surgery end; Nefopam 20mg, Propacetamol 2g, and Nefopam 20mg+Propacetamol 2g. In addition, patients will take the same medication every six hours during POD 1.<br>Drug: Propacetamol<br>* Patients undergoing thyroidectomy receive medications depending on the group allocation 30minutes prior to the surgery end; Nefopam 20mg, Propacetamol 2g, and Nefopam 20mg+Propacetamol 2g. In addition, patients will take the same medication every six hours during POD 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score on wound site and posterior neck | Patients' subject pain score through VAS on the surgery wound site and posterior neck. | one hour after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional pain rescue drug | how much of pain rescue drugs taken besides PCA | for postop. 24hrs. | 
| Postoperative nausea and vomiting | nausea score (0-none, 1- a little, 2- moderate, 3-severe) and vomiting (all or none) | for postop. 24hrs. | 
| Patient satisfaction | Patients satisfaction score ( 0- dissatisfaction, 1- a little dissatisfaction, 2- average, 3- a little satisfaction, 4- satisfaction) | for postop. 24hrs. | 
| Chronic pain and neurogenic pain | Neuropathic pain diagnostic questionnaire(DN 4) : The DN4 questionnaire consists of a total of 10 items grouped in 4 sections. The first seven items are related to the quality of pain (burning, painful cold, electric shocks) and its association to abnormal sensations (tingling, pins and needles, numbness, itching). The other 3 items are related to neurological examination in the painful area (touch hypoesthesia, pinprick hypoesthesia, tactile allodynia). A score of 1 is given to each positive item and a score of 0 to each negative item. The total score is calculated as the sum of all 10 items, and the cut-off value for the diagnosis of neuropathic pain is a total score of 4/10. All questions are related to pain which is the claim for current medical consultation. | three month after the surgery. | 
| acute VAS on wound site and posterior neck | VAS for patients' subject pain scor | postop. 24hrs. |