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NCT Number: NCT02577068

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.

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Key information

Conditions

Thyroidectomy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nefopam

Drug

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

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 16, 2015
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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