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Combination Effect of Nefopam With Propacetamol for Postoperative Pain After Thyroidectomy

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ClinicalTrials.gov Identifier: NCT02577068
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Thyroidectomy Pain Drug: Nefopam Drug: Propacetamol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : November 15, 2015
Actual Primary Completion Date : August 23, 2016
Actual Study Completion Date : August 23, 2016

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.




Primary Outcome Measures :
  1. VAS score on wound site and posterior neck [ Time Frame: one hour after the surgery ]
    Patients' subject pain score through VAS on the surgery wound site and posterior neck.


Secondary Outcome Measures :
  1. Additional pain rescue drug [ Time Frame: for postop. 24hrs. ]
    how much of pain rescue drugs taken besides PCA

  2. Postoperative nausea and vomiting [ Time Frame: for postop. 24hrs. ]
    nausea score (0-none, 1- a little, 2- moderate, 3-severe) and vomiting (all or none)

  3. Patient satisfaction [ Time Frame: for postop. 24hrs. ]
    Patients satisfaction score ( 0- dissatisfaction, 1- a little dissatisfaction, 2- average, 3- a little satisfaction, 4- satisfaction)

  4. Chronic pain and neurogenic pain [ Time Frame: 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.


  5. acute VAS on wound site and posterior neck [ Time Frame: postop. 24hrs. ]
    VAS for patients' subject pain scor



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577068


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02577068    
Other Study ID Numbers: 4-2015-0746
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Propacetamol
Nefopam
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents