Combination Effect of Nefopam With Propacetamol for Postoperative Pain After Thyroidectomy

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 Overview

• Status: Completed
• Conditions: Pain; Thyroidectomy
• Intervention / Treatment: Drug: Nefopam; Drug: Propacetamol

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: nefopam group	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.
Active Comparator: propacetamol group	Drug: 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.
Experimental: nefopam and propacetamol group	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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional pain rescue drug	how much of pain rescue drugs taken besides PCA	for postop. 24hrs.
Postoperative nausea and vomiting	nausea score (0-none, 1- a little, 2- moderate, 3-severe) and vomiting (all or none)	for postop. 24hrs.
Patient satisfaction	Patients satisfaction score ( 0- dissatisfaction, 1- a little dissatisfaction, 2- average, 3- a little satisfaction, 4- satisfaction)	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.	three month after the surgery.
acute VAS on wound site and posterior neck	VAS for patients' subject pain scor	postop. 24hrs.

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• 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. doi: 10.1089/thy.2006.16.599.

Study record dates

Study Major Dates

• Study Start: November 15, 2015
• Primary Completion (Actual): August 23, 2016
• Study Completion (Actual): August 23, 2016

Study Registration Dates

• First Submitted: October 6, 2015
• First Submitted That Met QC Criteria: October 13, 2015
• First Posted (Estimate): October 16, 2015

Study Record Updates

• Last Update Posted (Actual): March 21, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Nefopam; Propacetamol
• Other Study ID Numbers: 4-2015-0746