Combination Effect of Nefopam With Propacetamol for Postoperative Pain After Thyroidectomy

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT02577068

Collaborator

(none)

Enrollment

Location

Arms

9.3

Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroidectomy Pain	Drug: Nefopam Drug: Propacetamol	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Nov 15, 2015

Actual Primary Completion Date :

Aug 23, 2016

Actual Study Completion Date :

Aug 23, 2016

Arms and Interventions

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.

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

Experimental: nefopam and propacetamol group

Drug: Nefopam

Drug: Propacetamol

Outcome Measures

Primary Outcome Measures

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

Additional pain rescue drug [for postop. 24hrs.]
how much of pain rescue drugs taken besides PCA
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)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT02577068

Other Study ID Numbers:

4-2015-0746

First Posted:

Oct 16, 2015

Last Update Posted:

Mar 21, 2019

Last Verified:

Feb 1, 2019

Additional relevant MeSH terms:

Propacetamol

Nefopam

Study Results

No Results Posted as of Mar 21, 2019