Combination Effect of Nefopam With Propacetamol for Postoperative Pain After Thyroidectomy

Yonsei University84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Thyroidectomy Pain

Interventions

NefopamDRUG

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.

PropacetamolDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, South Korea

Outcomes

Primary Outcomes

VAS score on wound site and posterior neck

Patients' subject pain score through VAS on the surgery wound site and posterior neck.

Time frame: one hour after the surgery

Secondary Outcomes

Additional pain rescue drug

how much of pain rescue drugs taken besides PCA

Time frame: for postop. 24hrs.

Postoperative nausea and vomiting

nausea score (0-none, 1- a little, 2- moderate, 3-severe) and vomiting (all or none)

Time frame: for postop. 24hrs.

Patient satisfaction

Patients satisfaction score ( 0- dissatisfaction, 1- a little dissatisfaction, 2- average, 3- a little satisfaction, 4- satisfaction)

Time frame: 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.

Time frame: three month after the surgery.

acute VAS on wound site and posterior neck

VAS for patients' subject pain scor

Data from ClinicalTrials.gov

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