Combination Effect of Nefopam With Propacetamol for Postoperative Pain After Thyroidectomy

Not Applicable

Completed

• Conditions: Thyroidectomy; Pain
• Interventions: Drug: Nefopam; Drug: Propacetamol

• Registration Number: NCT02577068
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-16
• Study Start: 2015-11-15
• Primary Completion: 2016-08-23
• Study Completion: 2016-08-23
• Status Verified: 2019-02
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nefopam group	Nefopam	-
nefopam and propacetamol group	Nefopam	-
nefopam and propacetamol group	Propacetamol	-
propacetamol group	Propacetamol	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Additional pain rescue drug	for postop. 24hrs.	how much of pain rescue drugs taken besides PCA
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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of