Combination Effect of Nefopam With Propacetamol for Postoperative Pain After Thyroidectomy

Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02577068
• Other study ID #: 4-2015-0746
• Status: Completed
• Phase: N/A
• Start date: November 15, 2015
• Est. completion date: August 23, 2016

Study information

• Verified date: February 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Pain
• Thyroidectomy

Intervention

Drug:
• Nefopam
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.
• Propacetamol
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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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

Outcome

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.