Pain Clinical Trial
Verified date | February 2019 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | August 23, 2016 |
Est. primary completion date | August 23, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Han DW, Koo BN, Chung WY, Park CS, Kim SY, Palmer PP, Kim KJ. Preoperative greater occipital nerve block in total thyroidectomy patients can reduce postoperative occipital headache and posterior neck pain. Thyroid. 2006 Jun;16(6):599-603. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Additional pain rescue drug | how much of pain rescue drugs taken besides PCA | for postop. 24hrs. | |
Secondary | Postoperative nausea and vomiting | nausea score (0-none, 1- a little, 2- moderate, 3-severe) and vomiting (all or none) | for postop. 24hrs. | |
Secondary | Patient satisfaction | Patients satisfaction score ( 0- dissatisfaction, 1- a little dissatisfaction, 2- average, 3- a little satisfaction, 4- satisfaction) | for postop. 24hrs. | |
Secondary | 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. | |
Secondary | acute VAS on wound site and posterior neck | VAS for patients' subject pain scor | postop. 24hrs. |
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