Pain, Thyroidectomy
Conditions
Brief summary
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.
Interventions
DRUGNefopam
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.
DRUGPropacetamol
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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS score on wound site and posterior neck | one hour after the surgery | Patients' subject pain score through VAS on the surgery wound site and posterior neck. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional pain rescue drug | for postop. 24hrs. | how much of pain rescue drugs taken besides PCA |
| Postoperative nausea and vomiting | for postop. 24hrs. | nausea score (0-none, 1- a little, 2- moderate, 3-severe) and vomiting (all or none) |
| Patient satisfaction | for postop. 24hrs. | Patients satisfaction score ( 0- dissatisfaction, 1- a little dissatisfaction, 2- average, 3- a little satisfaction, 4- satisfaction) |
| Chronic pain and neurogenic pain | three month after the surgery. | 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. |
| acute VAS on wound site and posterior neck | postop. 24hrs. | VAS for patients' subject pain scor |
Countries
South Korea
Outcome results
None listed